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)
Contraindications for a medical device show the situations and conditions that should not be used.
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.
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.
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)
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.
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)
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.
Normal use without use error. (EN 62366-1:2015/A1:2020)
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.
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.
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.
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 )
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.
