Health insurers warn against compromises on patient safety and clinical evidence.

In March, the European Commission hosted a high-level conference on the revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Around 400 representatives from politics, industry and healthcare discussed the legislative proposal presented on 16 December 2025 (see News 12/2025). In her closing remarks, Sandra Gallina, Director-General of DG SANTE, struck a self-critical tone. Europe, she said, had itself created a problem of medical device shortages through some of the more extreme elements of risk avoidance. Reflecting on the existing regulatory framework, Gallina acknowledged: “We did not get it right.” The MDR, developed in 2017 in response to several medical device scandals, had in some respects gone too far. According to the European Commission’s assessment, the regulation has proven too complex and overly burdensome. The new proposal is therefore intended to bring greater simplification and reduce administrative burden.

From patient safety to new political priorities

Nevertheless, it should be recalled that the original reform was a direct response to serious medical device scandals – including faulty brain stents causing strokes, hip and knee implants with material wear, and breast implants made of industrial silicone. These cases clearly demonstrated , to the detriment of patients , the consequences of insufficient regulation.

Against this background, the MDR was established with a clear focus on patient safety. This objective remains in place, as emphasised by the Commission. At the same time, the current revision – also evident in the conference discussions – shows that additional objectives have gained importance. Alongside quality and patient safety, strengthening the European health industry, ensuring product availability and enhancing the competitiveness of the internal market are increasingly coming into focus.

Comprehensive reform rather than a purely technical adjustment

The legislative proposal presented in December is therefore clearly guided by the political mandate of simplification and reducing administrative burden. Objectives such as relieving stakeholders, accelerating procedures and ensuring the availability of medical devices are in principle understandable and justified. At the same time, however, the proposal goes well beyond the announced “technical adjustment” and constitutes a comprehensive reform of the existing regulatory framework – with potentially far-reaching implications for patient safety, quality of care and the requirements for clinical evidence.

Role of statutory health insurers

Given the responsibility of statutory health insurance for providing care to around 75 million insured persons in Germany, the safe, effective and reliable supply of medical devices is of central importance. Health insurers are not only responsible for financing, but are also directly confronted with the consequences of regulatory decisions for healthcare provision, quality and patient safety. Reliable clinical evidence and transparent market surveillance are therefore indispensable prerequisites for sound reimbursement decisions. This also applies in the context of the European Health Technology Assessment (EU HTA), which relies on a robust and comparable evidence base.

Perspective of health insurers

From the perspective of the German Social Insurance (DSV), simplification must not be equated with deregulation. Efficiency gains should be realised in a targeted manner where they improve procedures without undermining the high level of protection established by the MDR and IVDR. Uniform requirements for clinical evidence, market surveillance and traceability remain essential prerequisites for patient safety, trust and high-quality healthcare.

At the same time, strengthening the European market in the long term is crucial. This cannot be achieved solely by reducing administrative barriers to production and market access – and certainly not by lowering clinical evidence requirements. On the contrary, a key competitive advantage of Europe lies in its high quality and safety standards (“Made in Europe”), which must be preserved and further developed. Consistent quality oversight throughout the entire lifecycle of a medical device – from development and market placement to use – remains as indispensable as a robust clinical evidence base.

Against this background, the central question of the current revision arises: where does necessary simplification end, and where does deregulation begin?

With its position paper, the DSV is contributing to the ongoing discussions with the following key priorities:

• Clinical evidence requirements must not be lowered.
  
• Special regimes for orphan, breakthrough and well-established technologies must be clearly limited.
  
• Transparency and binding rules in market surveillance and in addressing shortages must be strengthened.
  
• Liability provisions and patients’ rights must be consistently safeguarded.
  
• Digitalisation should be used in a targeted way to make procedures more efficient and enable genuine reduction of administrative burden.
  

Outlook

The DSV will closely accompany the further legislative process from this perspective. Discussions in the Council began on 23 March, and in the European Parliament the rapporteur, Oliver Schenk (EPP/DE), is expected to present his draft report in early summer. The objective remains to achieve simplification where it is meaningful – without compromising patient safety, quality of care and evidence-based regulation.