On May 26, 2017, the Council of the European Union has adopted the European Medical Device Regulations 2017/745 (MDR), which were published in the Official Journal of the European Union and entered into force in the same date. The official date of application for the MDR will be May 26, 2020.

 

The new MDR replaces the existing MDD (Medical Device Directive), and amongst many new requirements, it emphasizes the importance of sufficient clinical evidence for existing and newly developed devices.

 

The intent of the new requirements is completely emphatic. One of the key objectives of the new EU MDR is to ensure a high level of health and safety protection for EU citizens. Making clinical investigation and evaluation requirements more stringent is aimed at improving health and safety through transparency and traceability.

 

Using clinical justifications based on device equivalence has been a standard practice for a long time. As per the requirements of the MDR, equivalence is going to be less accepted, particularly for higher risk devices. Consequently the clinical studies will become more important, especially for Class III and implantable devices where the MDR expressly requires clinical studies to be performed.

This means that starting from May 2020, a conformity procedure will be possible to be performed only based on sufficient clinical data coming from appropriately planned and performed clinical studies for these devices.

 

And that’s not all. More attention should be paid to the fact that based on current interpretation of relevant requirements of the MDR, from May 2020 only clinical studies performed and approved in the European Union will be accepted by Notified Bodies in a conformity assessment procedure for obtaining the CE mark for all medical devices. Using local CRO’s broad connections to the best investigational sites across Europe and a vast experience in the field is more important than ever.    

 

Obviously this will have its own transition period as well: clinical studies started before May 2020 will be possible to finish as they are, and they could be accepted as a source of clinical data for the Clinical Evaluation. However, after May 2020 studies can be performed only in one or more member states of the EU in order to be accepted by the NBs and CAs. All studies will need to be approved in EUDAMED, the existing, but extended database made publicly available, which will integrate information regarding devices and the relevant economic operators, certain aspects of the conformity assessment, notified bodies, certificates, clinical investigations, vigilance and market surveillance.  This web-based portal will enhance information-sharing between Member States, economic operators, notified bodies, sponsors, and the Commission. Use of the EUDAMED database will be mandatory. For Class III devices and implantables, the mandatory summary of safety and clinical performance will be made available to the public via EUDAMED post-notified body validation.