Andreas Schwab, CDU Member of the European Parliament for the administrative district of Freiburg, has indicated that the European Commission has decided to initiate a “Corrigendum procedure” for the Regulation (EU) 2017/745 on medical devices (EU-MDR). The procedure would request that the deadline for certification of Class Ir reusable devices under the new MDR be granted a transition period beyond May 2020. The amendment aims to ensure patient safety by allowing a focus on certification of high-risk devices and prevent an undersupply of class Ir medical devices.

The potential for undersupply has been attributed to the combination of the reduction in number of Notified Bodies and delays in the designation of Notified Bodies under the EU-MDR. Accordingly, there is an expectation that there will be a lack of capacity for Notified Bodies to assess applications for Class Ir Medical Devices certification prior to the deadline, resulting in those devices awaiting certification being unable to be placed on the market after May 2020. Further details on the proposed submission and length of the transition period are yet to be released.

For the extension to come into effect, a corrigendum or amendment to the EU-MDR must be approved by the European Parliament. This requires the submission by the European Commission to the European Council prior to involvement of the European Parliament. It is likely that the earliest submission to the European Parliament would be in Dec 2019, leaving less than 6 months for the corrigendum to be legislated into the EU-MDR before the May 2020 deadline.

SFL is closely following the implementation of the MDR/IVDR to identify emerging compliance challenges for devices in the EU and the Swiss markets, and provides strategic support for companies to ensure readiness and a smooth transition. SFL provides integrated solutions for medical devices in response to political and legislative changes in the EU and Switzerland. Contact us to discuss how SFL can support to prepare your business against disruption when the new MDR/IVDR comes into full effect.