Conscious, intentional act or intentional omission of an act that is counter to or violates normal use and is also beyond any further reasonable means of user interface-related risk control by the manufacturer. (EN 62366-1:2015/A1:2020-Article3.1)
Authorised representative means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under MDR Regulation; (MDR-Chapter 1, Article 2)
All manufacturers outside the EU-Zone require a registered representative within the EU to apply for CE Marking. Authorized Representatives carry out specific tasks for registration/documentation and can be audited on behalf of the manufacturers.
A medical device has to have more benefits than its risks; therefore, during and after the product development, the manufacturer has to make an active risk/benefit assessment and ensure that the device’s benefit exceeds the risks. (AdviQual Definition)
CE marking of conformity or CE marking means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in MDR Regulation and other applicable Union harmonisation legislation providing for its affixing; (MDR-Chapter 1, Article 2)
This is the conformity assessment per relevant regulation on the product. It literally stands for European Conformity's french version Conformite Europeenne. All products: laptops, phones, ovens have to have a CE mark to pass the relevant safety level for the EU public. For medical devices, it also stands for market clearance; without CE Certification, a manufacturer cannot place their products on the EU market.
Clinical Benefit means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health. (MDR-Chapter 1, Article 2)
Clinical Evaluation means a systematic and planned process to continuously generate, collect, analyse, and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer; (MDR-Chapter 1, Article 2)
Conformity assessment body means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection; (MDR-Chapter 1, Article 2)
The activity of the product/process/organisation that is complying with the clauses of the standard or the requirement. Notified Bodies perform conformity assessments and grant certification as a proof/result of the conformity assessment.
Normal use without use error. (EN 62366-1:2015/A1:2020)
A structured way of product design within the medical device industry. It practically is defining the user/product requirements, checking if all requirements are met by testing (verification), reviewing if the right product is designed (validation) once all the requirements are met releasing the product into the market. All medical device products have to be developed with a design controls strategy; conformity assessment carried out by NBs, and other product standards enforce this method to the manufacturers.
The GSPR, known as General Safety and Performance Requirements, is the director of any medical device CE marking. The GSPR has 23 requirements under MDR and 20 requirements under IVDR. The manufacturers who want to get their device CE marked should comply with these requirements and have sufficient evidence and conformity evidence to prove that they have complied with the GSPR.
Potential source of harm (EN 14971:2019- Article 3.4)
Instruction For Use (IFU) is the collection of information provided by the manufacturer to show the intended use of a medical device, contraindications, the proper use of the device, and the precautions to be taken during its use.
Indications are defined as all clinical conditions (diagnosis, treatment, monitoring etc..) a medical device is used for.
Label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents. (EN ISO 13485:2016+A11:2021)
It is the information that has to be communicated-user end-user about instructions and product specifications (use-by date, lot no). Labelling is not only applicable to the label but includes all the information about the specifics of the product inside and outside the packaging, including the online versions.
‘Medical Device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
Notified Body means a conformity assessment body designated in accordance with MDR Regulation; (MDR-Chapter 1, Article 2)
The certification body that conducts conformity assessment at the manufacturers' facilities on behalf of the competent authority, usually the ministry of health. It depends on the classification of the product whether or not the involvement of NB is needed. Low-risk products-Class I do not require notified body involvement. All the other classes of products require notified body involvement and notified bodies to perform the CE Marking and Quality management System assessments and certify manufacturers.
The performance Evaluation report results from the performance evaluation of an In-vitro Diagnostic Device in question. It is a continuous process performed by the manufacturer to generate, collect, analyze and assess performance data of the In-vitro Diagnostic device in order to be able to show safety and performance.
Post Market Clinical Follow-up trials are clinical trials performed on a medical device bearing CE marked with the approved indication(s).
Periodic Safety Update Report is one of the reports that should be prepared by class IIa, IIb and class III device manufacturers as a result of the PMS plan. PSUR is updated at least annually (once a year) for class IIb and class III devices. The manufacturer of the class IIa devices should update it when needed and once every two years. PSURs prepared for class III and implantable devices are submitted to the Notified Body involved in the conformity assessment via EUDAMED; the Notified Body inserts its evaluation to the system by reviewing the report. (AdviQual Definition )
Use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behaviour. (EN ISO 14971:2019 Article 3.15)
Process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels.
Freedom from unacceptable risk.
SSCP stands for Summary and Safety of Clinical Performance to be prepared by class III and implantable device manufacturers by Article 32 of Medical Device Regulation (MDR). It should be validated by the Notified Body involved in the conformity assessment process and uploaded to EUDAMED following its validation. The manufacturers should provide the access link to the SSCP in EUDAMED on the product label or instruction for use. (AdviQual Definition)
The packaging around medical devices that allows those devices to be sterilised provides a microbial barrier and maintains sterility effectively up to the point of use is known as a sterile barrier system. A sterile barrier system is an essential part of a sterile medical device.
Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market; (MDR- Chapter 1, Article 2)
With this code, the product can be publicly searched, and complaints on the product/regulatory approvals-certifications can be seen. UDI has various options (UDI-DI & UDI-PI) and it depends on the nature of the product which of these are applicable.
User action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user.
User Interface means by which the user and the medical device interact.
If you have a product line that consists of medical devices in a variety of sizes or models or various quantities, determining the worst-case product scheme is a little bit tricky, especially when the worst-case scenario does not refer exclusively to the system or package. Considering the worst-case situations like mass, size, geometry, configurations, and different processes is essential if you want your sample for testing to represent all your product line. (AdviQual Definition)
A systematic way of reviewing the activities and relevant documentation to see if a company fulfils the requirements. Assessment is carried out by checking the documentation; however, it is essential that the manufacturer is performing the required activities within its operations.
Positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health (EN ISO 14971:2019-Section 3.2)
Ability of a medical device or material to perform with an appropriate host response in a specific application. (EN 10993-1:2020-Article 3.1)
Biocompatibility is a general term describing the property of material being compatible with living tissue. The ambiguity of the term reflects the ongoing development of insights into how biomaterials interact with the human body and eventually how those interactions determine the clinical success of a medical device. Biocompatible materials do not produce a toxic or immunological response when exposed to the body or bodily fluids.
Clinical evaluation report (CER) results from the clinical evaluation process of the medical device, performed following the clinical evaluation plan. Written and updated by the manufacturer in order to show conformity to GSPR (General safety and performance requirements)
Clinical data means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
Clinical Investigation means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device; (MDR-Chapter1, Article 2)
Clinical trial for medical devices is scientifically and ethically designed investigation to gather information regarding a medical device when used in human subjects when designing and running a clinical investigation for medical devices ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice, ICH GCP, Helsinki Declaration and local regulatory requirements should be followed.
Contraindications for a medical device show the situations and conditions that should not be used.
‘Custom-Made Device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices; (MDR- Chapter 1, Article 2)
Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between the national competent authorities and the European Commission. The public can access this portal in future to trace the information about products. (AdviQual Defnition)
Injury or damage to the health of people, or damage to property or the environment
Circumstance in which people, property or the environment is/are exposed to one or more hazards. (EN 14971:2019- Madde 3.5)
In vitro diagnostic medical devices (IVD) are tests used on biological samples (such as tissues, blood or urine) to determine the status of a person's health. Unlike medical devices or pharmaceuticals, IVDs never come into contact with a person. IVDs do not treat patients but provide information about the functioning of the body. IVDs do not cause direct harm but may pose risks if their use leads to an incorrect diagnosis. (AdviQual Definition)
Intended purpose means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation. (MDR-Chapter 1, Article 2)
Medical device regulation aims to ensure that patients have access to high-quality, secure, and efficient medical devices while preventing access to unsafe prepare products. Medical Device Regulation guarantees public health benefits and the protection of patients, health care staff, and the general public in the European Union. The latest European Medical Device Regulation (MDR) has been published in the Official Journal of the European Union. The MDR entered into force on 25 May 2017, marking the start of the transition period for manufacturers selling medical devices into Europe. (AdviQual Definition)
Operation, including routine inspection and adjustments by any user, and stand-by, according to the instructions for use or in accordance with generally accepted practice for those medical devices provided without instructions for use.
Product safety is provided for medical device packaging to keep the integrity of the package throughout its entire existence, including sterilisation, delivery, storage, handling, and use.
Proactive clinical follow up of the CE marked medical devices with approved indication. PMCF activities can be thoroughly designed and run clinical trials under MDR and ISO 14155, registries, retrospective studies or well-designed surveys with performance-related questions.
Post-Market Surveillance means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions; (MDR- Chapter 1, Article 2)
A quality management system (QMS) is defined as a formalised system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organisation’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. (AdviQual Definition)
Risk remaining after risk control measures have been implemented. (EN ISO 14971:2019 Article 3.17)
In every medical device from software to implant, there are common challenges with application, design, and process. Risk management is the forecasting and assessment of those challenges, as well as the detection of procedures to prevent or mitigate their effects. EN ISO 14971:2019 standard illustrates how to incorporate an effective risk management system for medical devices. (AdviQual Definition)
Software as a Medical Device can be described as a medical software designed to carry out one or more medical functions without the need for actual hardware. (AdviQual Definition)
Statistical Sampling: It is the approach of how many products you want to test in which scenario; this approach has to have a scientific, statistical validity. Statistical Sampling is a part of verification/validation and also clinical evaluation.
Sterilization refers to any process that removes, kills, or deactivates all forms of life and other biological agents like prions present in a specific surface, object or fluid. Sterilization can be achieved through various means, including heat, chemicals, irradiation, high pressure, and filtration. After sterilization, an object is referred to as being sterile or aseptic.
The feature of the USER INTERFACE that ensures EFFECTIVENESS, EFFICIENCY and USER satisfaction in the designed USER ENVIRONMENT (EN 62366-1:2015/A1:2020)
It is undeniable that your medical device design is superior in certain engineering aspects. Have you considered the human factor? Usability is a statistical study that assesses how well a particular user in a specific situation can use a product/design to accomplish a given purpose effectively, efficiently, and satisfactorily. EN / IEC 62366-1 standard describes the application of information regarding human nature, skill, shortcomings, and other characteristics to the design of medical devices (including software), structures, and tasks to ensure sufficient usability.
User means any healthcare professional or lay person who uses a device.
Validation simply checks if the right device or procedure is designed. In a typical medical device design, requirements are set (however can be changed later) at the beginning of the device development. Validation is checking the final product or process fulfils the initial requirements that the manufacturer determined. Since it is not practical to remember the requirements at every stage of product development, this final stage validation check gives a level of confidence if the right product or process is designed.
