Any change in the product design means a difference in the "design inputs." When the design input changes, the “design outputs,” “design verification,” and “design validations” that depend on these inputs should be reviewed and repeated if necessary.
Design verification is the process of verifying inputs and outputs. If we verify the input-output of a part of the product, only that part can be tested. However, if the result of the test affects the operational functions of the whole product, it should be applied to the finished product.
There is an obligation to prove the accuracy and validity of the test. If you are not working with an accredited laboratory, you should know the test method. You should audit the laboratory and keep relevant records such as testing, reporting, and the suitability of the laboratory environment.
It must be demonstrated that the test method is suitable for its intended use. This is achieved by performing a series of tests on the procedure, materials, and equipment that make up the method. Each step must be documented. Test Method Validation should be applied for tests that need to be applied.
Validation is required for all processes in which the equipment is involved. E.g., such as sterilization, packaging, injection, and extrusion. However, verifying the processes manually operated such as soldering, visual inspection, and pH testing, is required.
A validation study is a teamwork. We recommend that this team include at least equipment specialists, production engineers, quality assurance specialists, and senior management for approval.
We recommend that you pay attention to all items, but the items below may require special attention.
Yes, the software used in the product or in the quality management system must be validated. The following standards can be used as a source for software validation.
With the introduction of EU 2017/745 MDR and EU 2017/746, the requirements for the cyber security of medical devices that can be connected to a network have increased. Some new basic safety requirements have been established for all medical devices, including electronic programmable systems and software that are medical devices themselves. Manufacturers are required to design and manufacture their products in accordance with the latest technology, taking into account risk management principles, including information security, and establish minimum requirements for IT security measures, including protection against unauthorized access. It should not be forgotten that cybersecurity begins at the design stage of the device and must be ensured throughout the product's entire life cycle.
Guidelines for cyber security are as follows:
Within the scope of the EN ISO 13485:2016 standard, each of the following steps should be implemented carefully.
1. Design Planning: A design plan is prepared by forming a project team for products not included in the current product portfolio; it is planned to be produced upon management decision, market research, tenders, or customer demands. It may consist of the main topics such as the target, scope, compliance strategy, time constraints of the design, as well as actions, responsibilities, obstacles, clinical evaluation plan, and clinical development plan.
2. Design Inputs: Inputs should be entirely understandable and detailed. It should be noted that the verification method can be defined for each input. The suitability of the inputs should be structured in a way that they do not contradict each other. All applicable clauses of the 2017/745 Annex 1 GSPR and items requiring special attention should be considered to ensure that the device is designed to meet specifications and performance requirements.
3. Design Outputs: Design outputs are generated to meet the design input requirements. It is necessary to create output evidence that matches the inputs. If there is a deviation between outputs and inputs, the required actions must be determined and documented.
4. Design Review: A review is a systematic evaluation of design results. The review system gives feedback and provides information about existing or potential problems. The review team should act in accordance with an impartial approach.
5. Design Verification: In order to ensure that design outputs meet input requirements, verification processes are carried out and recorded at the appropriate design stages.
6. Design Validation: It is carried out to ensure that the product conforms to the defined user needs or conditions. Following the design verification, validity checks are performed on the finished product or separately for each purpose under defined conditions of use.
7. Design Transfer: This is the section where the design team examines the results and decides to start mass production. Generally, tests required by the standards are carried out by producing a sample with a small lot. The results are evaluated, and their suitability is examined. In the simplest terms, it is the phase in which the design is transferred to the production stage.
8. Design Changes: The changes applied for each phase are kept in the design revision file.
A detailed answer is given in the document “GS1 Healthcare GTIN Allocation Rules Standard”, published by GS1.
YES, provided that MDD/AIMDD certificates are not withdrawn by the notified body.
Where the relevant legal requirements are no longer met by the manufacturer or the certificate should not be issued, the notified body may withdraw a certificate, taking into account the principle of proportionality. The fact that the device is MDR certified is not a reason for the notified body to withdraw the MDD/AIMDD certificate.
This means: a 'legacy device' and the corresponding MDR-compliant device can be placed on the market in parallel until the end of the relevant transition period.
Article 120(3a) of the MDR introduces new transition periods depending on device risk classification. For this purpose, the classification rules set out in Annex VIII of the MDR apply.
In some cases the classification rules of the MDR may result in a different risk class. In this case, the risk class of the device specified in the certificate may be different from the risk class that determines the end date of the transition period.
However, where the risk class of the device is necessary to determine which MDR requirements apply during the transitional period (e.g. for the preparation of a PSUR), the class of the device is determined in accordance with the MDD classification rules (see MDCG 2021-25).
Certificates expiring before the entry into force of amending Regulation (EU) No 2023/607 (before 20 March 2023) shall only be considered valid if:
Even if the duration of the national derogation is limited or the manufacturer is required to carry out the conformity assessment procedure within a specified period, the device benefits from the full transitional period until 31 December 2027 or 31 December 2028 (as appropriate), provided that the conditions set out in Article 120(3c) of the MDR are met. The certificate shall be considered valid until the end of the applicable transitional period, unless withdrawn.
In accordance with Article 120(3c), (e) of the MDR, the manufacturer or authorized representative shall submit a formal application for conformity assessment in accordance with Section 4.3, first subparagraph, of Annex VII to the MDR by 26 May 2024 at the latest.
In order to benefit from the extended transition period, the manufacturer and the notified body shall sign a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII to the MDR by 26 September 2024 at the latest.
Article 120(3c) subparagraph (e) of the MDR does not refer to the review of applications in the third subparagraph of Section 4.3 of Annex VII of the MDR. This means: the application does not have to be fully reviewed by the notified body before the written agreement is signed.
The application should, in principle, contain the elements specified in the relevant conformity assessment referred to in Annexes IX to XI of the MDR.
The period between the deadline for the application (May 2024) and the actual conformity assessment activities to be carried out by manufacturers and notified bodies may be very long (up to 2028 at the latest). Therefore, documents that are not essential for signing the agreement and that can be updated until the conformity assessment is actually carried out do not need to be submitted with the application. For example, technical documentation for each device covered by the application and subject to technical documentation review may not be submitted at the time of application. When submitting the application, the manufacturer must specify a timetable for the submission of individual technical documents and other relevant information and agree on a plan for conformity assessment activities with the Notified Body.
The application should clearly identify the manufacturer and the devices covered by the application; for example, it may include a list of devices intended to be transferred to the MDR and, where applicable, the device(s) intended to replace a legacy device. The information submitted with the application should allow verification by the notified body of the qualification of the products as devices, their respective classification and the conformity assessment procedure chosen.
Where an application for conformity assessment of a device intended to replace a legacy device is submitted, not only the substitute device but also the legacy device intended to be replaced must be identified. The technical documentation of the substitute device may be submitted at a later stage.
The manufacturer must comply with the quality management system (QMS) requirements of the MDR by May 26, 2024 at the latest. Therefore, the application for conformity assessment of the QMS must include documentation on the manufacturer's QMS.
The term "device intended to replace that device" is used in the second subparagraph of Article 120(2) subparagraph (a), Article 120(3c) subparagraph (e) and the second subparagraph of Article 120(3e) of the MDR.
A device intended to replace a legacy device will usually (but not necessarily) be different from the legacy device. This is because the manufacturer has made (substantial) changes to the design or intended use of the device in order to replace the legacy device.
It is the responsibility of the manufacturer to identify the device intended to replace the legacy device and to explain its connection with the legacy device.
It should be noted that the device intended to replace the legacy device will need to undergo a full MDR conformity assessment before being placed on the market.
The transition period provided for in Article 120(3a) and (3b) of the MDR only applies to a "legacy device replaced by an equivalent device".
After MDR certification of the equivalent device, the legacy device and the equivalent device may be placed on the market in parallel until the end of the relevant transition period.
Hayır.- Provided that the application is not rejected, applications submitted before the entry into force of amending Regulation 2023/607 (i.e. before March 20, 2023) remain valid and are sufficient to fulfill the condition set out in Article 120(3c), point (e) of the MDR. There is also no need to sign a new written agreement.
The limitation in the third subparagraph of Article 120(3e) of the MDR indicates that there may be circumstances where the notified body issuing the MDD/AIMDD certificate may not be able to sign the contract (e.g. termination of business).
In any case, even in the event that the notified body issuing the MDD/AIMDD certificates is unable to be involved, a written agreement must be concluded between the manufacturer and the MDR notified body setting out the arrangements for appropriate surveillance to be carried out by the MDR notified body.
Even when appropriate surveillance is transferred to a different notified body designated under the MDR, legacy devices may continue to be placed on the market and put into service without modification of the labelling, including the CE marking, and may bear the number of the notified body which issued and maintains the validity of the certificate under the Directive.
However, the manufacturer may decide (where practically possible and subject to the details contained in the tripartite agreement) to change the labeling of legacy devices bearing the number of the notified body to which a formal application under the MDR was made.
In Article 120(4) of the MDR and Article 110(4) of the IVDR, the deadline for the continued placing on the market of devices placed on the market in accordance with previously applicable directives has been deleted.
Incidents may not be reported to competent authorities in accordance with Article 87(1) of the MDR. However, the manufacturer shall document incidents, maintain them in the quality management system and report them in accordance with the requirements set out in Article 88 of the MDR.
Serious incidents shall be reported by the manufacturer to the relevant competent authority in accordance with Article 87(1) to (5) of the MDR.
If an incident is judged not to be a serious incident on initial assessment, it should nevertheless be investigated, taking into account the circumstances, whether it could have led to one of the consequences set out in Article 2(65)(a) to (c) of the MDR. Examples of circumstances here include "if there had been no intervention by a third party" or "if more vulnerable patients had been exposed to the same situation", etc.
If the manufacturer cannot exclude the possibility that the incident may have led to the consequences referred to in Article 2(65)(a) to (c) MDR, the incident should be considered serious and reported to the relevant competent authority.
If, after becoming aware of a potentially reportable event, the manufacturer is uncertain whether the event is reportable, it should submit a report within the time required under Article 87(2) to (5) of the MDR.
The process to be followed by manufacturers for the management of incidents and serious incidents can be found in Flowchart 1 of the MDCG 2023-3 guidance.
In some cases, the device may not cause direct (or immediate) physical injury or harm to a person's health due to its intended use, but may cause indirect harm. Indirect harm may occur as a result of a medical decision made/not made, an action taken/not taken, or as a result of a treatment based on the information or result(s) provided by the device. Consequential harm resulting from an event that has or has the potential to have the consequences of a serious event must be reported in accordance with Article 87(1) to (5) of the MDR.
Examples of indirect harm: misdiagnosis, delayed diagnosis, delayed treatment, inappropriate treatment, absence of treatment, transfusion of inappropriate supplies.
According to Article 2(37) of the MDR, a "user" is any healthcare provider, healthcare professional or lay person (e.g. caregiver, patient) who uses the device, or any person who installs or maintains the device. The user of a device may also be referred to (e.g. in standards) as the operator.
"Use errors due to ergonomic features" can be defined as use errors resulting from device features designed to ensure that the device is easy, effective and safe to use by the target user.
Ergonomic features can be defined as the physical characteristics of a device that are designed to facilitate and ensure that the interaction between the user and the device is safe, effective and efficient. Ergonomic features of the device include components such as measurement and monitoring features, display scales, alarms, software menu and all other factors related to the user interface.
Errors in use due to ergonomic features can result from a mismatch between the device features (including the information provided in the user manual) and factors such as the user profile and/or the environment in which the device is intended to be used.
Note: In some cases (e.g. for devices where the patient is responsible for setting up or adjusting their own treatment, such as drug delivery devices, devices with diagnostic or measurement functions), use errors caused by ergonomic features may not be immediately detectable. As a result, there may be serious consequences due to the possibility that the error was unintentional and the user was not aware of it.
Errors of use caused by ergonomic features should be reported in accordance with Article 87(1) to (5) of the MDR if they are serious incidents, and in accordance with Article 88 of the MDR if the errors are incidents.
A serious deterioration in a person's state of health is considered "unexpected" if the condition leading to the deterioration has not been considered in the manufacturer's risk analysis.
A serious deterioration in a person's state of health is "anticipated" if it has been considered in the manufacturer's risk analysis and noted in the risk management report.
In the event of a serious deterioration in health, the manufacturer must provide documented evidence that a risk analysis has been used to eliminate or reduce, as far as possible, the risk associated with these events, or it must be shown that the risk is contained in the information communicated by the manufacturer to the user (e.g. the user manual).
Article 87(5) of the MDR outlines the timelines that manufacturers should use to report an unexpected serious deterioration in a person's state of health.
Under the MDR, the seriousness of the serious incident should be taken into account when making the reporting referred to in Article 87(1) of the MDR.
Timelines for reporting serious incidents should be considered in calendar days, i.e. reporting periods include weekdays, public holidays, Saturdays and Sundays.
As a general rule, the reporting period starts at 0:0:1 on the day after the date of awareness of a potentially serious incident. The date of awareness (day=0) refers to the date on which the manufacturer first became aware or received information that a (potential) serious incident had occurred, not after conducting its investigation.
The reporting timelines set out in the MDR are as follows:
-Any serious incident that does not involve death or an unexpected serious deterioration in a person's state of health must be reported as soon as a causal link between the device and the serious incident has been established or is reasonably possible and no later than 15 days from the date of awareness of the serious incident (Article 87(3) of the MDR),
-A serious public health threat must be reported immediately and no later than 2 days after the manufacturer becomes aware of the threat (Article 87(4) of the MDR),
-Death or an unexpected serious deterioration in a person's state of health must be reported as soon as a causal link between the device and the serious incident is established or suspected, and no later than 10 days from the date of awareness of the serious incident (Article 87(5) of the MDR).
As a general rule and in exceptional cases, the deadline expires on the 15th, 2nd or 10th day after this date (more specifically at 23:59:59). However, if this (last) day is a public holiday, Saturday or Sunday, the deadline is automatically shifted to the next working day. However, in line with the reporting requirement of Article 87(3), (4) and (5) of the MDR, the manufacturer is strongly encouraged to report immediately or at the earliest possible time.
Example: A manufacturer receives a complaint on June 1, 2022. The manufacturer decides that the serious incident criteria are not met and therefore does not submit an MIR to the relevant competent authority. The manufacturer then receives additional information on July 1, 2022. Upon review of this information, the manufacturer decides that the complaint is a serious incident. In this case, it must submit an MIR by July 16, 2022 at the latest.
Continuation of the example with variation: On July 2, 2022, the manufacturer became aware that a patient died on July 2, 2022. As the outcome of the serious incident is now a patient death, a report must be submitted no later than 10 days after the date of awareness of the serious incident. Therefore, the MIR must be submitted no later than July 12, 2022. Consequently, this is the earliest reporting date to be considered.
A delay in the submission of the initial report due to incomplete information provided by the healthcare facility, end-user or other relevant parties is not justified. As stated in Article 87(6) of the MDR, the manufacturer may submit an initial MIR and then a follow-up report with additional information on the (potentially) serious incident and progress in the incident investigation(s). Any report should not be unduly delayed due to missing information.
The "Final, (Non-reportable incident)" report type is used in cases where the manufacturer has submitted an MIR to the relevant competent authority, but its investigation found that the serious incident criteria (Article 87(1) of the MDR) were not met. It is included in the MIR under Section 1.2(d).
The "Final (Non-reportable event)" report type should be used when:
In the above cases, the manufacturer may check the box "Final (Non-reportable event)" in section 1.2(d) of the MIR and provide a justification for its conclusion in section 4.2(b).
The "Final (Non-reportable incident)" report type may also be used in cases where the manufacturer has received a report of a potentially serious incident from the competent authorities (Article 87(11) of the MDR) but has determined that the requirements of a serious incident have not been met within the timeframes set out in Article 87(3) to (5) of the MDR. In such cases, the manufacturer may submit a final MIR by selecting the report type "Final (Non-reportable event)" and provide a justification for its conclusion in section 4.2(b).
An incident cannot be considered non-reportable if the manufacturer has not completed a root cause analysis or has not identified the cause and/or contributing factors. In such cases, an MIR with report type "Final (Non-Reportable) incident" should not be submitted to the relevant competent authority.
Pursuant to Article 87(1)(b) of the MDR, for FSCAs carried out in a third country in relation to a device legally offered for sale in the Union market, all relevant competent authorities must be notified, unless the reason for the FSCA is limited to devices offered for sale in the third country.
An example of such an FSCA would be a recall of a device in a third country due to a malfunction occurring in certain lots. If the lots affected by this recall were also placed on the Union market, all competent authorities concerned must be notified of the FSCA.
Eudamed is the new European database for medical devices that will centralize all information on devices placed on the Union market. The database is defined and described in Article 33 of the MDR and its specific requirements on vigilance are summarized in Article 92 of the MDR.
Until EUDAMED is fully functional, competent authorities, economic operators and other interested parties should follow the "MDCG 2021-1 Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional" approved by the Medical Device Coordinating Group (MDCG).
The MDCG guidance includes alternative temporary solutions for the implementation of specific MDR provisions related to Eudamed. It also details the exchange of information to ensure that Member States and other interested parties fulfill their obligations under the MDR until Eudamed is fully functional.
Information on how to proceed in the event that Eudamed becomes technically unavailable or malfunctions after it becomes fully functional and on alternative mechanisms to be used for data exchange can be found in the "COMMISSION IMPLEMENTING REGULATION (EU) No 2021/2078 of 26 November 2021 laying down the rules for the implementation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 26 November 2021 on the European Database for Medical Devices (Eudamed)".
A "Periodic Summary Report (PSR)" is an alternative reporting method whereby the manufacturer can report similar serious incidents relating to the same device or device type in a consolidated manner, rather than reporting them individually. Here, the manufacturer should act in agreement with the relevant national competent authority coordinating periodic summary reporting (and in consultation with the competent authorities referred to in Article 92(8)(a) of the MDR).
Periodic summary reporting may be undertaken for similar serious incidents occurring on the same device or device type where the root cause has been identified or a site safety corrective action has been implemented, or where there are "common and well-documented" serious incidents.
The requirements for periodic summary reporting are set out in Article 87(9) of the MDR.
Medical Device Symbols are to be used with medical device labels when supplied. These symbols are a part of the regulatory requirements by leading regulatory bodies including the EU and FDA.
Applicable Label Standards
Medical Device Symbols used in Active & Non Active Devices
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SYMBOL |
TITLE |
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Name and Address of the Manufacturer |
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Date of Manufacture |
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Use by Date |
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Authorized representative in the European Community/European Union |
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Consult instructions for use or consult electronic instructions for use |
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Lot Number |
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Catalogue Number |
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Serial number |
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Importer |
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Distributor |
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Model number |
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Country of Manufacture |
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Sterile |
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Sterilize Use Aseptic Processing |
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Sterilized using ethylene oxide |
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Sterilized using irradiation |
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Sterilized using steam or dry heat |
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Do not resterilize |
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Non-Sterile |
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Do not use if package is damaged |
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Sterile fluid path |
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Sterilized using vaporized hydrogen peroxide |
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Single sterile barrier system |
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Double sterile barrier system |
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Single sterile barrier system with protective packaging inside |
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Single sterile barrier system with protective packaging outside |
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Fragile, handle with care |
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Keep away from sunlight |
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Protect from heat and radioactive sources |
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Keep dry |
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Temperature Limit |
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Humidity limitation |
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Atmospheric pressure limitation |
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Biological risks |
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Do not re-use |
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Caution |
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Contains or presence of natural rubber latex |
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Contains human blood or plasma derivatives |
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Contains a medicinal substance |
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Contains biological material of animal origin |
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Contains biological material of human origin |
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Contains hazardous substances |
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Contains nano materials |
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Single patient multiple use |
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In vitro diagnostic medical device |
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Control |
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Negative Control |
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Positive Control |
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Contains sufficient for |
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For IVD performance evaluation only |
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Sampling site |
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Fluid path |
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Non-pyrogenic |
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Drops per millilitre |
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Liquid filter with pore size |
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One-way valve |
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Patient number |
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Patient Name |
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Patient identification Indicates the identification |
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Patient information website |
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Health care centre or doctor |
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Date |
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Medical Device |
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Translation |
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Repackaging |
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Unique device identifier |
If the sample size is not specified in the specific standard of the test, the number of samples to be used must be statistically significant.
The worst-case condition sample is the product that will encompass all and the most difficult features to represent the product family. Aim; is to show that the result covers other products in the product group by performing the relevant tests on the worst-case sample. It should be noted that the "worst-case condition" may vary for each test group, and there may be more than one "worst-case condition" sample for a test.
You can conduct them in-house if you have the appropriate test environment and can validate your test method.
People should do tests with proven competencies. These competencies can include but are not limited to equipment usage, test method knowledge, and disposal.
IQ(Installation Qualification),-OQ(Operational Qualification) and PQ (Performance Qualification) steps should be followed in the validation study. If you need to skip a step, we recommend that you write a justification in your report.
You should always prepare and keep the documents according to your Document and Record Control Procedure, which you have prepared in accordance with the EN ISO 13485:2016 standard. Ensure that raw data reports are generated in accordance with good record-filling guidelines.
Classify your software as MDCG 2019-11. (EU) 2017/745 – MDR and (EU) 2017/746 Regulations with the Guidance on Software Qualification and Classification.
Rule 11 – Software for decisions with diagnosis or therapeutic purposes or software intended to monitor physiological processes
Software intended to provide information that is used to make decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
- death or an irreversible deterioration of a person's state of health, in which case it is in class III; or
- a serious deterioration of a person's state of health or surgical intervention, in which case it is classified as class IIb.
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I.
Rule 12 – Active devices intended to administer and/or remove substances
All active devices intended to administer and/or remove medicinal products, body-liquids or other substances to or from the body are classified as class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.
As software devices cannot physically administer and/or remove substances, please refer to the implementation rule 3.3 of Annex VIII for MDSW covered by this rule.
4.2.3. Rule 13 – All other active devices
All other active devices are classified as class I
Taking into consideration all implementing and classification rules applicable to active devices, if no other rule applies, all other active devices are class I.
4.2.4. Rule 15 - Devices used for contraception
All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb, unless they are implantable or long-term invasive devices, in which case they are classified as class III.
Rule 15 applies to devices used for contraception or prevention of the transmission of sexually transmitted diseases. Software used for contraception will be classified as class IIb.
Rule 22 – Closed-loop systems
Active therapeutic devices with an integrated or incorporated diagnostic function that significantly determines the patient management by the device, such as closed-loop systems or automated external defibrillators, are classified as class III.
Decide whether your product meets the requirements for the subtests subject to revision in both standards. If additional testing is required, you should have your product tested for this test.
Make sure that you have established a risk management system in accordance with EN ISO 14971:2019 standard. If you are looking for examples in application areas, you can use “ISO/TR 24971:2020 Medical devices - Guide to the implementation of ISO 14971” as a source.
It is also important that the UDI-DI barcoding system is a process that requires validation after it is installed.
Only "legacy devices" can benefit from the extended transition period. These devices can be;
The extension of the transitional period beyond 26 May 2024 is only valid if the conditions set out in Article 120(3c) of the MDR are met.
For devices for which the relevant certificate expired before March 20, 2023, in addition to the above requirement, the conditions set out in the second subparagraph of Article 120(2), (a) or (b) of the MDR shall also be met
Manufacturers do not have to apply for legacy devices under the MDR.
If their devices have a certificate whose validity expires after 20 March 2023 and before 26 May 2024, they benefit from an extension of the transitional period until 26 May 2024, provided that the conditions set out in Article 120(3c), points (a) to (c) of the MDR are met.
If the manufacturer does not submit an application for conformity assessment by 26 May 2024, the transitional period will expire on 26 May 2024.
New Article 120(3f) of the MDR introduces a special transitional period for class III custom-made implantable devices.
While all other custom-made devices can be placed on the market after their manufacturer has prepared a declaration in accordance with Annex XIII of the MDR, the conformity assessment of class III custom-made implantable devices requires the involvement of a notified body.
According to the new transitional provision, class III custom-made implantable devices may be placed on the market without the relevant certification until 26 May 2026, provided that the manufacturer submits an application to a notified body for conformity assessment by 26 May 2024 at the latest and signs a written agreement with that notified body by 26 September 2024 at the latest.
The extension of the transition period and the consequent extension of the validity of the certificate shall be automatic by law if the conditions set out in Article 120(3c) of the MDR are fulfilled.
For devices for which the relevant certificate expired before March 20, 2023, the conditions set out in the second subparagraph of Article 120(2), points (a) or (b) shall also be met.
In line with MDCG guidance 2020-34, notified bodies may not issue new MDD/AIMDD certificates during the transition period. However, they may issue written approvals correcting or supplementing information in an existing certificate.
There are situations where the manufacturer needs to demonstrate the validity of its certificate to third parties (e.g. to access the market in third countries or to bid in supply procedures). Therefore, manufacturers should have access to different tools to demonstrate that their devices are covered by an extended transitional period and a valid certificate.
Competent authorities should be able to issue free sale certificates during the validity period of the extended certificate.
The European Commission will update the factsheets for competent authorities, healthcare professionals and healthcare institutions and the supply ecosystem in non-EU/EEA countries to explain the functioning of the extended transition period.
A written agreement in accordance with Section 4.3, second subparagraph, of Annex VII of the MDR must be concluded between the notified body and the manufacturer in accordance with Article 120(3c), (e) of the MDR by 26 September 2024 at the latest. The requirements set out in Section 4.3, second subparagraph, of Annex VII of the MDR remain unchanged.
The formal application by the manufacturer or authorized representative should form the basis for signing the written agreement. Indications on the possible timetable for the submission of relevant documentation not submitted at the time of application should be included in the written agreement.
In order to promote consistency between notified bodies, NBCG-Med, in agreement with the MDCG working group Oversight of Notified Bodies (NBO), may provide additional clarification on the standard elements to be included in the written agreement referred to in Article 120(3c) (e) of the MDR.
The term "device intended to replace that device" is used in the second subparagraph of Article 120(2) subparagraph (a), Article 120(3c) subparagraph (e) and the second subparagraph of Article 120(3e) of the MDR.
A device intended to replace a legacy device will usually (but not necessarily) be different from the legacy device. This is because the manufacturer has made (substantial) changes to the design or intended use of the device in order to replace the legacy device.
It is the responsibility of the manufacturer to identify the device intended to replace the legacy device and to explain its connection with the legacy device.
It should be noted that the device intended to replace the legacy device will need to undergo a full MDR conformity assessment before being placed on the market.
The transition period provided for in Article 120(3a) and (3b) of the MDR only applies to a "legacy device replaced by an equivalent device".
After MDR certification of the equivalent device, the legacy device and the equivalent device may be placed on the market in parallel until the end of the relevant transition period.
The documentation on the QMS must be part of the application for conformity assessment and must be prepared by the manufacturer.
Compliance with the QMS-related requirements on post-market surveillance, market surveillance, inspection and registration is part of the appropriate surveillance process under Article 120(3e) of the MDR.
The assessment of the conformity of the entire QMS to the MDR shall be carried out by the notified body as part of its conformity assessment activities.
The arrangements for the transfer of appropriate surveillance for devices covered by the written agreement referred to in Article 120(3c), subparagraph (e) of the MDR should be determined by an agreement between the manufacturer and the MDR notified body to which the formal application was submitted and, where applicable, the notified body issuing the MDD/AIMDD certificates, in accordance with the third subparagraph of Article 120(3e) of the MDR.
The written agreement referred to in Article 120(3c), subparagraph (e) of the MDR and the agreement on the transfer of surveillance address different issues. However, depending on what is more convenient for the parties concerned (e.g. where the notified body issuing the MDD/AIMDD certificate is not involved), they may be combined into a single document.
The arrangement for the transfer of surveillance should follow the same principles as set out in Article 58(1) of the MDR and should include the transfer of the relevant documents from the outgoing notified body to the incoming notified body.
The agreement (tripartite agreement) between the outgoing notified body, the incoming notified body and the manufacturer should also address the possibility for the MDR notified body to suspend or withdraw a certificate issued by the MDD/AIMDD notified body, if duly justified.
The transfer of surveillance activities also takes place if the MDR notified body has not previously been appointed under the MDD/AIMDD.
As stated in the third subparagraph of Article 120(3e) of the MDR, the incoming notified body does not take responsibility for the conformity assessment activities performed by the issuing notified body.
In accordance with Article 120(3e) of the MDR, the notified body that issued the relevant certificate under the MDD/AIMDD remains responsible for appropriate surveillance in relation to the devices it certifies.
Alternatively, before 26 September 2024, the manufacturer may agree with an MDR notified body to make it responsible for surveillance. Not later than 26 September 2024 (MDR Article 120(3c), subparagraph (e)), the notified body signing this agreement shall be responsible for appropriate surveillance.
Article 120(3e) of the MDR provides that the supervision (obligation) of the previous notified body shall continue until 26 September 2024 at the latest.
Unless otherwise provided for in the tripartite agreement, the use of the number of the notified body that issued the certificate shall not be prevented until the end of the transition period.
According to Article 2(64) of the MDR, an "incident" is any malfunction or deterioration in the characteristics or performance of a device placed on the market. This includes errors in use resulting from ergonomic features of the device, inadequacies in the information provided by the manufacturer and unintended side effects.
According to Article 2(65) of the MDR, a "serious incident" is an event that has caused or has the potential to cause significant health or public health consequences, in addition to those referred to in Article 2(64). Serious incidents are a subset of incidents that directly or indirectly cause or may cause the death of a patient, user or other person, or serious temporary or permanent impairment of health, or pose a serious public health threat.
The key difference between an "incident" and a "serious incident" under the MDR is the seriousness of the health or public health consequence (or potential consequence) resulting from a problem with a marketed device.
Any incident that meets all three basic criteria listed below is considered a serious incident and should be reported to the relevant competent authority:
A- An incident has occurred (Article 2(64) of the MDR), and
B- The incident directly or indirectly led, might have led, or might lead, any of the consequences of a serious incident (Article 2(65) of the MDR), and
C- A causal relationship between the serious incident and the manufacturer's device has been established or is reasonably possible or suspected.
Criterion A: Occurrence of an event
Examples can be listed as follows:
Criterion B: The incident directly or indirectly led, might have led, or might lead any of the consequences of a serious incident
For this criterion to be met, it is sufficient that an event associated with the device has occurred and that this event, if it were to occur again, has caused or could cause any of the following consequences:
* A serious deterioration in the health status of a patient, user or other person may include:
a. a life-threatening illness or injury,
b. permanent or temporary impairment of body structure or a bodily function (including disorders leading to diagnosed psychological trauma),
c. a condition that requires hospitalization or prolongation of an existing hospital stay,
d. medical or surgical intervention to prevent a or b (e.g. professional medical care or unplanned additional medical treatment, a clinically significant increase in the duration of a surgical procedure)
e. a chronic disease,
f. fetal distress, fetal death or any congenital abnormality (including congenital physical or mental impairment) or birth defects.
Note: Indirect harm as a result of a medical decision or action taken/not taken based on the information or result(s) provided by a device may also result in a serious deterioration in the health status of a patient, user or other person, leading to serious events.
** A serious public health threat (MDR Article 2(66)) refers to an event that may result in imminent risk of death or serious deterioration in a person's state of health or serious illness; a serious disease that may require urgent remedial action and may cause serious morbidity or mortality in persons; or an event that is unusual or unexpected for a particular place and time.
Events of serious public health threat include:
Examples of serious public health threats include the following:
A serious threat to public health is in principle not limited to a single incident or an individual patient problem. The identification of these events may depend on signal detection or trending of multiple events of the same nature/typology, with the same root cause, etc.
Criterion C: a causal relationship between the serious incident and the manufacturer's device has been established or is reasonably possible or suspected
The manufacturer must investigate whether there is a causal relationship between the serious incident and its device or whether such a causal relationship is reasonably possible.
When assessing the link between their device and a serious incident, the manufacturer should consider factors such as:
Establishing or identifying the link between the manufacturer's device and the serious event can be difficult, especially when multiple devices and medicines are involved. In complex cases, it should be assumed that the device may have contributed or potentially contributed to the serious incident and the manufacturer should therefore be cautious in its assessment and conclusions. In case of doubt, the manufacturer should still submit the report referred to in Article 87(1) of the MDR.
A "malfunction or deterioration in the characteristics or performance of a device" in Article 2(64) of the MDR can be defined as a situation where a device, when used in accordance with the information supplied with the device, fails to achieve or maintain the performance intended by the manufacturer (Article 2(22) of the MDR).
Examples of device malfunctions:
Examples of deterioration in the characteristics or performance of the device:
If a device used in accordance with the information provided by the manufacturer fails to achieve or maintain its performance, the manufacturer should always conduct a root cause investigation.
A "use error" is an action taken or omitted by the user while using the device that results in a result or output that is different from that expected by the user or intended by the manufacturer.
Errors in use may result from the user's inability to pay attention, memory lapses or mistakes made during the use of the device, or from a lack of understanding or knowledge about the use of the device. These types of handling errors do not fall under the definition of an incident. However, errors in use resulting from the ergonomic characteristics of a device do qualify as incidents and may be reportable under Article 87(1) of the MDR for serious incidents.
Errors in use should be documented and evaluated within the manufacturer's quality management system, just in case.
"Abnormal use" is a deliberate violation of the intended use of a device. It is an intentional act or omission of an act by the user that is contrary to or violates the normal use of a device.
An example of abnormal use is when a doctor uses a device for a different indication than the one specified in the instructions for use, based on a medical judgment. This is also an example of off-label use of a device. Abnormal use of a device should be documented and evaluated within the manufacturer's quality management system.
An "unintended side effect" under the MDR is to be understood as any medical symptom that is unintended and unwanted in the human body as a result of the normal use of a device. Unintended side effects are not the result of a malfunction, deterioration in the characteristics or performance of the device or inadequacy in the information provided by the manufacturer.
A failed treatment (or treatment failure) should not be considered an unintended side effect.
For the purpose of this document, unintended side effects may be expected or unexpected side effects and are considered events under the MDR (Article 2(64)).
Expected undesirable side effects should be clearly listed in the product information and quantified in the manufacturer's technical documentation. These side effects should be acceptable in comparison with the benefits resulting from the performance of the device under normal conditions of use (MDR Annex I Section 8).
Expected unintended side effects should be reported in accordance with the trend reporting requirements under Article 88 of the MDR.
If the manufacturer cannot demonstrate that a potentially serious event is an expected unintended adverse side effect within the timeframes set out in Article 87(3) to (5) of the MDR, it must submit a Manufacturer Incident Report (MIR) within the reporting timeframes.
Unexpected undesirable side effects are not taken into account in the manufacturer's risk analysis, quantified in the manufacturer's technical documentation or presented in the product information. When unexpected unintended side effects occur, they should be treated as any other event. Therefore, if unexpected unintended side effects qualify as serious incidents under Article 2(65) of the MDR, they should be reported as individual serious incident reports (i.e. individual MIRs) under Article 87(1) of the MDR.
The terms " immediately" and "without undue delay" in the timelines for the reporting requirements set out in Article 87 of the MDR should both be understood to mean "without any delay that may be caused by the intentional or negligent act or omission of the manufacturer".
The report referred to in Article 87(1) of the MDR should be submitted within the timelines set out in Article 87(2) to (5) of the MDR, without undue delay or any delay that the manufacturer cannot justify.
To ensure timely reporting, the manufacturer may submit an initial MIR followed by a follow-up report (Article 87(6) of the MDR).
The "manufacturer awareness date" in the timelines for reporting a serious incident under Article 87 of the MDR is the date on which the first employee or representative of the manufacturer organization receives information (e.g. a complaint) about a potentially serious incident. If the handling of complaints and incidents is carried out by the authorized representative, or if these activities are outsourced to another natural or legal person (e.g. a subcontractor), the reference to the "manufacturer's organization" in the context of the date of awareness will also apply to that organization.
- 1.2.c. " Manufacturer awareness date" (in this field the manufacturer should enter the date of first awareness of the event).
- Section 5 "General comments" (in this field, the manufacturer should enter the date on which he/she received the information that determined that the event was reportable ("Date of manufacturer's awareness of reportability")).
In the general comments section in section 5 of the MIR, the manufacturer should also explain the difference between the two dates (manufacturer awareness date and reportability awareness date).
It should be noted that if the manufacturer is not sure whether the incident is a serious incident, it must still submit an MIR within the deadlines set out in Article 87(2) to (5) of the MDR.
Example: A manufacturer receives a complaint on July 1, 2022. The manufacturer determines that the serious incident requirements are not met and does not submit an MIR to the relevant competent authority. The manufacturer then receives additional information on August 1, 2022 and, after reviewing this information, decides that the complaint is a serious incident.
The manufacturer must then submit an MIR within the deadlines specified in the relevant sections of the MDR, i.e. immediately and no later than 15, 2 and 10 days after August 1, 2022 (the day after) (Article 87(3) to (5)). In the MIR, the manufacturer must include the dates as follows:
- 1.2.c. Manufacturer awareness date: July 1, 2022.
- Section 5 General comments: August 1, 2022, and an explanation of the difference between the two dates.
A "Field Safety Corrective Action (FSCA)", as referred to in Article 2(68) of the MDR, is a corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident associated with a device in use.
An FSCA may include:
- the return of a device to the supplier or a recall,
- a device replacement,
- a device modification,
- modification by the manufacturer or retrofitting by the buyer of the design change,
- a device destruction,
- advice given by the manufacturer regarding the use of the device, such as maintenance, cleaning instructions, training and/or additional information on the follow-up of patients, users or others,
- audits/inspections recommended by the device user (e.g. regular professional checks of proper functioning in a test environment),
- software / firmware changes to the device, including device update (e.g. rollback).
Note: Manufacturer recommendations may include changes to the clinical management of patients to address the risk of death or a serious deterioration in health status specifically related to the characteristics of a device. For example, in cases involving implantable devices, removal of the device is often not clinically justifiable. Specific patient follow-up or treatment would therefore constitute measures to be included in an FSCA.
An FSCA must be brought to the attention of the users or customers of the device in question without delay by means of a "Field Safety Notice (FSN)" sent by the manufacturer.
The content of the FSN must be consistent in all Member States, unless duly justified in relation to the situation of an individual Member State (e.g. a translation error in the instruction manual which occurs only in certain languages and therefore affects only certain countries). The FSN must be issued in an official Union language or in the languages specified by the Member State in which the FSCA was obtained.
The MDR requirements on the content of the FSN are summarized in Article 89(8) paragraph 2 of the MDR.
Example of FSCA conducted by a manufacturer: As part of post-market surveillance activities, the manufacturer detects a systematic device failure. If the affected devices are available on the market and have caused or have the potential to cause a serious incident, the manufacturer must initiate an FSCA to prevent or reduce the risk of such incidents.
The FSCA implemented by the manufacturer may include permanent or temporary changes to the device's labeling or instructions for use, or a recall of all affected devices on the market.
The manufacturer shall inform without delay the relevant competent authority(ies) in the Member State(s) in which the FSCA has been or will be carried out. Furthermore, the manufacturer shall ensure that information on the FSCA is brought to the attention of affected users without delay through an FSN.
For the purposes of Article 89 of the MDR on the analysis of serious incidents and site safety corrective actions, "evaluating competent authority" means the national competent authority of the Member State responsible for assessing the risks arising from serious incidents occurring and reported within its territory and/or the adequacy of the FSCAs foreseen or undertaken by the manufacturer within its territory (Article 89(2) and (3) of the MDR).
The competent authority in the Member State in which the manufacturer or its authorized representative has its registered place of business must always be informed about the FSCA, even if it is not among the Member States in which the FSCA is or will be carried out.
In the context of commenting on the content of the draft FSN as set out in paragraph 1 of Article 89(8) of the MDR, the manufacturer should, except in emergencies, submit the draft FSN to the evaluating competent authority for review and comment. In the cases referred to in Article 89(9) of the MDR, the draft FSN should be submitted to the designated coordinating competent authority.
In all cases, the final FSN should be communicated to all competent authorities carrying out the assessment.
Under Articles 10, 13 and 14 of the MDR, manufacturers, importers and distributors are required to notify competent authorities of devices that present or are considered to present a serious risk. A "serious risk" is defined here as a situation in which serious harm is likely to result from the use of a device that could affect patients, users or the public. Serious risk may also include situations where the effects of the risk are not immediately apparent.
In the case of a device presenting a serious risk, the manufacturer, importer or distributor shall immediately inform the competent authorities of the Member States in which they make the device available and, where applicable, the notified body which issued the certificate for the device in accordance with Article 56 of the MDR.
For an event to be a "common and well-documented" serious event referred to in Article 87(9) of the MDR, it must be clearly identified in the manufacturer's risk analysis and lead to incident reports to be considered by the manufacturer and the relevant competent authority. The serious event and the root cause must be clinically well known to the manufacturer (i.e. a certain qualitative or quantitative predictability must be established).
