Cyprus Presidency of the Council of the EU Presents Progress Report on Medical and In Vitro Devices Negotiations

Cyprus Presidency of the Council of the EU Presents Progress Report on Medical and In Vitro Devices Negotiations

On 5 June 2026, the Cyprus Presidency of the Council of the EU presented a progress report on the proposed regulation simplifying the rules of medical and in vitro diagnostic devices.  For context, the European Commission published the proposed regulation on 16 December (more information available in a previous news article available here).

Within the Council of the EU, delegations welcome the proposal and support its objectives of incentives for innovation, simplification, reduction of disproportionate burden and fostering more uniform practices of notified bodies. While examination of the proposal in the Working Party on Pharmaceuticals and Medical devices is still ongoing, it seems that additional work with a view to refining and complementing the proposal will be necessary to reach a General Approach (the Council of the EU’s position), notably as regards the following aspects:

• Several delegations consider that a clearer delineation of tasks and responsibilities and the relationship between the European Medicine Agency and the Medical Device Coordination Group should be defined.
• Delegations overall welcome the changes proposed by the Commission to improve coordination among competent authorities regarding the qualification of a product or the classification of a device. However, several delegations propose further streamlining of the procedures to avoid bottlenecks in EU level coordination and to enable more efficient and consistent outcomes at EU level.
• Whereas most delegations welcome the introduction of a definition of ‘well-established technology device’ which will be subject to more proportionate requirements, they also underline the need for further refinement and clarification of the criteria.
• Overall, delegations welcome the strengthened and coordinated oversight of notified bodies to ensure uniform practices. However, several delegations remain cautious regarding the costs and resources needed for involving Joint assessment teams (JAT).
• The proposal makes the involvement of notified bodies in the conformity assessment and surveillance activities more proportional to the risk of devices and introduces some elements of flexibility in the conduct and frequency of audits by notified bodies. In addition, the proposal introduces changes to the reporting by manufacturers and broadens the type of evidence a manufacturer can rely on. However, several delegations identify certain regulatory gaps and remain cautious regarding the cumulative impact of some of the simplifications proposed by the Commission.
• Several delegations are supportive of the Commission proposal to prevent overlaps and to create one regulatory framework for Artificial Intelligence (AI)-enabled medical devices by limiting the application of the Artificial Intelligence legislation to medical devices. However, some delegations wish to complement the proposed implementing and delegated acts to lay down specific sectoral requirements regarding AI.