Medical Device Regulation once again in the focus of European health policy.

The European healthcare policy once again focuses on the availability and supply of medical devices and in-vitro diagnostics. The reasons for this are the upcoming evaluation of the regulatory framework of the Medical Device Regulation (MDR) in 2025, the new European Commission under the leadership of the Hungarian Health Commissioner-designate Olivér Várhelyi and a resolution of the European Parliament. The topic has literally become a long-burning issue.

Wait for an evaluation or act immediately?

On 23 October, the European Parliament adopted a resolution calling for an urgent revision of the MDR. The resolution is a response to implementation issues that have led to bottlenecks for medical devices – in particular, niche and orphan products – and challenges for small and medium-sized enterprises (SMEs). The European Parliament calls on the European Commission to systematically review the MDR and the In Vitro Diagnostic Regulation (IVDR) framework, reduce unnecessary administrative burdens and make the certification process more efficient.

Discussion about deadlines and adjustments

In the run-up to the resolution, there were intensive discussions between the political groups, in particular about the timing and scope of possible adjustments. The European Parliament is calling on the Commission to submit delegated and implementing acts on the MDR and IVDR by the end of the first quarter of 2025. This could include making it easier for small and medium-sized companies in re-certifying existing products or implementing fast-track authorisation procedures for medical devices that close a therapeutic gap. An amendment motion tabled by the EPP that sought to enshrine the targeted amendments in the resolution by the end of the third quarter was rejected. The Commission should propose a systematic review of all relevant articles of these regulations as soon as possible, accompanied by an impact assessment. This routine evaluation was scheduled for 2025 anyway.

Health Commissioner-designate signals readiness to act

In his hearing before Parliament, the Health Commissioner-designate, Olivér Várhelyi, emphasised that he will take up Parliament's demands and examine and propose targeted amendments through delegated acts by the end of the first quarter of 2025. From the German Social Insurance (DSV)'s point of view, it is positive that a comprehensive renegotiation of the MDR remains out of the question.

The first step should be a targeted evaluation of the EU regulations for medical devices and in-vitro diagnostics. This Consultation is due to start this year. Adjustments will then be reviewed and made on the basis of the results.

DSV calls for targeted adjustments for orphan devices

The DSV warns against rash adjustments to the MDR and rejects efforts to renegotiate the entire regulatory framework for medical devices and in-vitro diagnostics. The existing regulations already provide valuable safety and quality requirements that must not be weakened in the course of adjustments. A systematic and independent report on the reasons for the withdrawal of medical devices is needed. At the same time, however, the DSV sees a clear need for action with orphan devices, i.e. medical devices that are developed for orphan diseases and a small number of patients. From the DSV's point of view, special conformity assessment procedures for these devices therefore make sense. The technical documentation for devices with orphan status should be assessed by the responsible notified bodies. The clinical assessment and the intended purpose, on the contrary, should be reviewed by a central review authority at European level, while involving the expert panels of the European Medicines Agency (EMA). For detailed DSV proposals on orphan devices and other amendments to the MDR, refer to the DSV Opinion.