Medical device manufacturers are going to be confronted with major changes within the EU’s decades-old regulatory framework which governs market access to the EU. The EU MDR will replace the EU’s current MDR (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

Manufacturers of currently approved medical devices will be having a transition time of three years until May 26th, 2020 (which is now postponed to May 26th, 2021) to meet the requirements of the regulation. For some manufacturers, the new regulation provides a further time after the date of application allowing them to put new products for max four more years on the market.

In addition, to make sure a smooth transition from the Directives to the Regulations and to avoid market disruption several transitional provisions are in place until 2025. The new regulations contain a series of highly important improvements to modernize the existing system. Among them follows:

● Product scope expansion – The definition of medical devices and active implantable medical devices covered under MDR will be expanded to include devices that have no medical intended purpose, like contact lenses (Colored) and cosmetic implant devices and other materials. Devices designed for the “prediction and prognosis” of a disease or other health condition are also included in the scope of Regulation Devices.

● Identification of “qualified person”– Device manufacturers are required to identify one person at the least, within their organization who is ultimately responsible for all the aspects of compliance with the requirements of the new regulation. The organization should document the specific qualifications of this individual relating to the required tasks. Special relief may apply to micro and small enterprises.

● Implementation of unique device identification– The MDR mandates the use of UDI mechanisms. This requirement is expected to improve the ability of manufacturers and Authorities to trace specific devices through the supply chain, and also to facilitate the prompt and efficient recall of medical devices that have been found to pose a safety risk. Also, the European Databank on Medical Devices (Eudamed) is likely to be extended to provide more efficient access to information on approved medical devices.

● Rigorous post-market oversight– The MDR request increased the post-market surveillance authority by the Notified Body. Uninformed audits, along with product sample checks and product testing will improve the EU’s enforcement regime and helps to reduce the risks from unsafe devices.

● Specifications– The MDR plans to allow the EU Commission to be defined to publish Common Specifications which shall then be taken into account by manufacturers as well as Notified Bodies. These Common Specifications will be existing along with the Harmonized Standards and the State of the Art.

● Reclassification of devices according to risk, contact duration, and invasiveness –The MDR will require device manufacturers to check the updated classification rules and update their technical documentation accordingly by considering the very fact that class III and implantable devices will have higher clinical requirements and a proper scrutiny process.

● More rigorous clinical evidence for class III and implantable medical devices – Manufacturers are in need to conduct investigations in case they do not have sufficient clinical evidence to support the claims done on the safety and performance of a dedicated device. Device manufacturers are also being 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-Manufacturers will be in need to prepare their clinical evaluation again by considering the new wording of the regulation on when an equivalence approach and under which circumstances it’s possible to justify not conducting a clinical investigation.

● No “grandfathering” provisions– Under MDR, all existing approved devices must be recertified under the new requirements. Exemptions are under negotiation right now.