Until now, the rules for medical device manufacturers in Europe were laid out in the EU Medical Device Directive (93/42/EEC). In effect since 1993, this decades-old regulatory framework will be replaced by the EU’s Medical Device Regulation (MDR) (2017/745). The latter was published on May 2017 and will be coming into force on May 2020, after a transition period of 3 years. At the time of writing, this leaves manufacturers exactly a year to conform with the MDR.
Being a more inclusive yet more strict regulatory framework, the MDR can be considered a modern update of the existing medical device directive. This article is a brief summary in the form of a Q&A, about the key changes and most important points of the new EU medical device regulation.
The MDR has an expanded scope to include devices that are not strictly intended for medical purposes. Such device examples are cosmetic implants and colored contact lenses.
Firstly as is already the case with pharmaceuticals, the role of Qualified Person (QP) is introduced under the MDR. So a manufacturer defined Qualified Person will assume full responsibility for medical device compliance, under the MDR. Secondly, the MDR mandates the use of Unique Device Identification (UDI) mechanisms. These allow for fast tracking and tracing of every medical device anywhere in the supply chain, for both the authorities and manufacturers, ultimately aiding in more effective medical device products recalls. Lastly, the new EU medical device regulation will allow the Commission with the aid of expert panels, to define and publish Common Specifications. These will need to be taken into account by both Notified Bodies and medical device manufacturers.
One big change is that MDR requires more comprehensive clinical evidence for high risk medical devices, such as class III and implants. These need to cover any claims regarding both performance and safety of a medical device. Moreover, manufacturers will need to assess potential safety risks with clinical data acquired post market, after the medical devices have been marketed and are in widespread use.
Regarding classes IIa and IIb medical devices, clinical evaluation will need to be repeated according to the new EU medical device regulation. As a result, manufacturers may need to conduct a new clinical investigation, or take an equivalence approach and justify why their existing clinical investigation is adequate.
Yes, as every currently approved medical device must be recertified, under the new MDR. Moreover, the MDR requires medical device manufacturers to harmonize their technical documentation according to the new regulation. Then by taking into account the application risk, invasiveness, and duration of contact, manufacturers are to assess whether it is necessary for them to reclassify their medical devices.