During this pandemic period, we hear daily news of bottlenecks in the supply chain of medicine and medical devices. In the case of medical devices, the situation could deteriorate significantly if application of the EU Medical Devices Regulation (EU MDR) becomes mandatory as planned in May 2020.
Even before the pandemic, there was considerable pressure on medical device manufacturers, as the majority of the notified bodies required for conformity assessment have not been re-certified or are no longer available due to Brexit. In addition, essential legal acts and guidelines for the implementation of the Medical Devices Regulation are still pending and, in view of the current crisis and the associated administrative burden, are not expected to be available in the foreseeable future.
Broad-based transitional provisions are now required. These may be initiated not only by the EU but also by the German Federal Government, based on Article 59 of EU MDR. According to Article 59, any competent authority may authorise the placing on the market or putting into service within the territory of the Member State concerned, of a specific device which has not undergone a conformity assessment procedure, where its use is in the interest of public health or patient safety or health. This regulation, which is geared to specific products and individual decisions, must now be used in order to be able to continue to supply products certified under the old law.
The Member State must inform the Commission and the other Member States of any such decision. The Commission may, in duly substantiated cases of extreme urgency, extend an authorisation granted by a Member State to the territory of the Union for a limited period of time by means of immediately applicable implementing acts. There is no question that the legislator had individual products in exceptional cases in mind here, which the wording of the Regulation also confirms. Nevertheless, this provision provides a basis for finding solutions in the interest of patients in an extraordinary situation for the health sector in a procedure clearly structured by the EU MDR and for averting new supply bottlenecks. It would be an important signal for the medical device manufacturers in order to regain some planning security in uncertain times.