On the postponement of the European Medical Devices Regulation

In 2010 the breast implant scandal of the French manufacturer Poly Implant Prothèse (PIP) was the catalyst to tighten the approval guidelines and the supervision of medical devices in order to better ensure patient safety. The MDR provides for a new classification of medical devices and requirements for clinical evaluation are increased. As part of a scrutiny process a committee of experts will be allo-wed to control the conformity assessment of high-risk medical devices. More stringent requirements will apply to the notified bodies that control manufacturers. For identification and traceability pur-poses, each medical device will receive a product identification number. On this basis, the MDR plans to create an EUDAMED database to centrally manage all approved medical devices and document their safety. There is no protection of existing products - all currently approved medical devices must be re-certified according to the new requirements.

The conversion to the new MDR is complex and time-consuming for both manufacturers and notified bodies. The process is complicated by the fact that there are too few Notified Bodies in Europe responsible for certification. For this reason, it was decided in December 2019 that the data bank EUDAMED would not be put into operation until 2022.

The current proposal to postpone the beginning of the new MDR has met with a high response. By reducing bureaucratic hurdles, it is expected that medical technology companies will be relieved and bottlenecks in medical care will be avoided during the corona crisis.

The SKC Beratungsgesellschaft has wide experience in reimbursement mechanisms and is very famili-ar with regulatory requirements. Already during the development and certification processes, SKC's experts can provide strategic support to their clients in order to successfully position innovative medical devices on the market.