The Medical Devices Regulation covers four main topics:
2. Conformity assessment procedure
3. Technical documentation
4. Quality management system
Not every medical device is the same and should therefore also not be treated as one entity. Therefore, the European Commission has divided medical devices in different classes. The different classes are divided by the risk that they impose. A low risk medical device should go through a different, less complex, conformity assessment procedure than a high risk medical device. The risk classes are divided from low, class I, to high, class III.
The following risk classes are identified in accordance with the Medical Devices Regulation:
– Class I, e.g. simple wound dressing.
– Class I with a measuring function, e.g. non-active oral thermometer.
– Class I sterile, e.g. sterile simple wound dressing.
– Class IIa, e.g. condoms.
– Class IIb, e.g. medical devices for the cleaning of contact lenses.
– Class III, e.g. medical devices integrating medicinal products.
Conformity Assessment Procedure
In order to indicate compliance of the medical device with the applicable European legislation the correct conformity assessment procedure must be carried out. The conformity assessment procedure depends on the classification of the medical device.
Manufacturers of medical device must ensure to have the required Technical Documentation in order regarding their medical device. The Technical Documentation entails all documentation which can be used to determine the compliance of the medical device with the applicable European legislation. The Technical Documentation entails minimally the following.
– Device description and specification (e.g. UDI, risk class, technical specifications etc.)
– Information regarding the labels and packaging.
– The instructions for use.
– Information regarding the manufacturing processes.
– Information regarding all production sites.
– Documentation demonstrating compliance with the general safety and performance requirements.
– The benefit-risk analysis.
– Documentation on all test results and analyses.
– Documentation on (pre-)clinical data.
– Quality Management System
Quality Management System
When medical devices are manufactured, they are often manufactured in series. In order to ensure the compliance of all the medical devices produced in series with the applicable European legislation, it is required for manufacturers to implement a Quality Management System (QMS). For instance in accordance with ISO 13485: 2016. In this way the presumption of conformity is determined of all the medical devices produced in series.