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Implementation of the Medical Devices Regulation

European Commission wants to extend risk-related transition periods

CC – 12/2022

On 26 May 2023, medical devices should have been re-certified according to the new Medical Device Regulation (MDR). But after months of debate about impending bottlenecks, the transition periods are now to be extended. This was announced by EU Health Commissioner Stella Kyriakides at the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting on 9 December.

Extension of the transition periods by 3 and 4 years respectively – depending on the risk group

In its information, the European Commission announced legislative and non-legislative measures to respond to impending shortages. The legislative proposals are to be presented in January 2023. Among other things, the European Commission intends to extend the transition periods. The extension would be staggered, with higher risk products having to be compliant by 2027 and lower risk products by 2028. However, strict conditions must be met for this, e.g. that the product has not been significantly modified and that manufacturers have already taken the necessary steps to initiate the certification process in accordance with the MDR. In addition, it should be possible to extend the validity of products which, according to the European Commission, do not pose a risk. In addition, the “sell off” provision in Article 120 (4) of the (EU) 2017/745 (MDR)are to be lifted.

Fast action required

In the debate, Member States welcomed the proposals and called for their rapid implementation. Germany, France and Ireland – as major industrialised countries – have taken the lead in keeping up the pressure on the European Commission and demanding swift action. Specific implementation proposals for the risk-based deadline extension were submitted by the Medical Device Coordination Group (MDCG) of the European Commission. In their position paper bridging measures for expiring certificates are proposed.

Transparency is still lacking

For the German Social Insurance, the MDR is an important step towards improving patient safety and the quality of treatment with medical devices. It is imperative that this premise remains in place for the measures announced. The temporary extension of the transitional periods must be subject to strict conditions that do not pose any risk to product safety. Companies must fulfil their obligations despite the announced extension. Despite all the political discussions, transparency is still lacking. More clarity is needed on the types of products that are at serious risk of being discontinued from the market. There must also be more transparency on the exact reasons for product discontinuation.

Background of MDR

The MDR was adopted at the suggestion of the European Commission in 2017 in response to the breast implant scandal in Germany and France and replaces the Medical Devices Directive that had been in force until then. The new regulation represents fundamental changes in the approval process for medical devices.