MDR – Medical Device Regulations
What is MDR?
The Medical Device Regulation was officially published on May 5th 2017 and came into force on May 25th 2017. Manufacturers of currently approved medical devices will have a transition time of three years until May 26th 2020 to meet the requirements of the regulation. For some manufacturers the new regulation provides an additional time after the date of application allowing them to place new products for maximum 4 more years on the market. Additional requirements will apply for this extended transition period. Click here to access the publied MDR on the Official Journal of the European Union. The corrigenda for the MDR and IVDR have also been made public in this official journal. The new MDR imposes strict demands on medical device manufacturers and the Notified Bodies whom they must involve in the approval process of medical devices other than self-declaration class I devices.
What are the Key Changes?
The MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. The most significant changes in the regulation include:
- Product Scope Expansion – The definition of medical devices and active implantable medical devices covered under the MDR will be significantly expanded to include devices that have not a medical intended purpose, such as colored contact lenses and cosmetic implant devices and materials. Also included in the scope of the regulation are devices designed for the purpose of “prediction and prognosis” of a disease or other health condition.
- Identification of Qualified Professional – Device manufacturers will be required to identify at least one person within their organization who is ultimately responsible for all aspects of compliance with the requirements of the new regulation. The organization must document the specific qualifications of this individual relative to the required tasks. Special relief may apply to so-called micro and small enterprises.
- Implementation of Unique Device Identification – The MDR mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers and Authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk. In addition, the European Databank on Medical Devices (Eudamed) is expected to be expanded to provide more efficient access to information on approved medical devices.
- Rigorous Post-Market Oversight – The MDR request increased post-market surveillance authority by the Notified Body. Unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime and help to reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers will also be required in many cases.
- Specifications – The MDR plans to allow the EU Commission or expert panels to be defined to publish common specifications which shall then be taken into account by manufacturers as well as Notified Bodies. These Common Specifications shall exist in parallel to the Harmonized Standards.
- Reclassification of Devices according to Risk, Contact Duration and Invasiveness – The MDR will require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.
- More Rigorous Clinical Evidence for Class III and Implantable Medical Devices – Manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical evidence to support the claims done on both safety and performance of a dedicated device. Device manufacturers will also be required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.
- Systematic Clinical Evaluation of Class IIa and Class IIb Medical Devices – Manufacturer will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.
- No Provisions – Under the MDR, all currently approved devices must be recertified in accordance with the new requirements. Exemptions are under negotiation right now yet not finalized.
The role of the Notified Bodies according to the EU Regulations:
As a fundamental rule, responsibility for ensuring that medical devices comply with legal requirements rests with the device manufacturers. For medical devices in higher risk classes, manufacturers need to involve a Notified Body in the approval process. The Notified Bodies must be designated by a national supervisory authority and notified by the EU Commission. The independence of the Notified Bodies is ensured by the notification system, which provides for continuous surveillance and regular re-designation by the supervisory authorities.