Guy’s and St Thomas’

The European Commission has proposed extending the transition period for the EU Medical Devices Regulation, addressing compliance challenges medical device manufacturers face. The move aims to mitigate potential shortages and ensure the availability of critical medical products in the European market.

The European Commission has responded to concerns surrounding the EU Medical Devices Regulation (MDR) by proposing an extension to the transition period for medical device makers. This move aims to address the challenges faced by manufacturers in meeting the stringent regulatory requirements and mitigate potential shortages of critical medical products in the European market.

The Commission acknowledged the limitations in the capacity of notified bodies responsible for ensuring compliance with the new regulatory framework. Recognising the potential impact on the availability of essential medical devices, the proposed extension grants medical device manufacturers additional time to achieve MDR compliance.

Under the proposal, high-risk devices would have until December 31, 2027, while low- and medium-risk devices would be granted an extended deadline until December 31, 2028, to complete conformity assessments. Notably, the proposal includes a provision for class III custom-made implantable devices, allowing for a new transition period until May 26, 2026. Manufacturers seeking this extension must have applied to a notified body by May 26, 2024, and finalised a certification contract by September 26, 2024.

To address concerns about potential shortages, the proposal eliminates the "sell-off" date provision under both MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR). This change allows devices compliant with former directives to remain on the market, reducing the risk of shortages. However, devices with limited shelf-life are explicitly excluded to prevent the offering of expired products.

Patient safety remains a priority, and the European Commission has outlined stringent conditions for applying extended transition periods. Factors such as the COVID-19 pandemic, supply chain disruptions, limited capacity of notified bodies, and economic operators' readiness have prompted the proposed extension. The Commission aims to ensure the continuous production of essential medical devices and uninterrupted access for needy patients.

European Health Commissioner Stella Kyriakides has expressed support for the proposal, emphasising the challenges faced by healthcare systems across the EU and the risk of medical device shortages. Kyriakides has urged swift adoption of the revised regulatory timeline. The proposal is now in an accelerated co-decision procedure involving the European Parliament and Council for final approval of the revised deadlines. Collaboration among stakeholders, including Member States, notified bodies, and industry players, will facilitate a smooth transition to the new regulatory framework outlined by the Medical Devices Regulation.

In conclusion, the European Commission's proposal to extend the transition period for the EU Medical Devices Regulation addresses compliance challenges medical device manufacturers face. By granting additional time and eliminating the "sell-off" date provision, the proposal aims to fortify the European medical device landscape and ensure the continued availability of critical medical products in the EU market. As the proposal progresses through legislative channels, stakeholder collaboration will facilitate a smooth transition to the new regulatory framework.