Opinion from German Social Insurance
issued 19 March 2026
Proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I
With the Regulation proposal presented on 16 December 2025 to simplify the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), the European Commission aims to simplify certification procedures, reducing administrative burdens and accelerating market access for medical devices. The regulatory framework is to be streamlined and future-proof to improve predictability and efficiency of procedures, reduce costs, remove barriers to innovation and ensure the availability of medical devices.
Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) constitute the central European legal framework for ensuring the quality and safety of medical devices and diagnostics. They are therefore key pillars of patient protection and of a high-quality, evidence-based healthcare system in the European Union (EU).
With the Regulation proposal, the European Commission intends to amend the MDR and IVDR to a significant extent. The proposed adjustments go far beyond mere “technical fixing”: more than three quarters of the articles of the MDR are amended in wording or substance. This constitutes a profound reform of the existing regulatory framework with potentially far-reaching implications for patient safety, quality of care, clinical evidence requirements and market surveillance. The European Commission bases its proposal largely on evaluations and feedback from stakeholders regarding the practical implementation of the MDR and IVDR. At the same time, publicly available, comprehensible, robust and systematically collected data are still lacking, for example on market withdrawals, supply shortages or national derogations.
The German Social Insurance (DSV) considers that a particularly careful assessment is required as to whether and to what extent regulatory simplifications are justified and what unintended consequences they may entail. The statutory health insurance funds are responsible for providing safe, effective and high-quality care to around 75 million insured persons in Germany. Uniform European requirements for clinical evidence, market surveillance and traceability are essential to minimise treatment risks, ensure quality of care and strengthen the trust of patients and medical professionals in medical devices and diagnostics. At the same time, reliable and needs-based provision of medical devices and in vitro diagnostic medical devices is essential for statutory health insurance. Shortages, market withdrawals or non-transparent special arrangements have a direct impact on the care of insured persons and on service providers.
Amendments to the MDR and IVDR are appropriate where they specifically reduce bureaucracy, make procedures more efficient and improve practical implementation without jeopardising the core objectives of the Regulations – a high level of protection for patients, evidence-based approval decisions and effective market surveillance.
Against this background, the DSV considers that the following points should be taken into account in the discussions on the revision of the MDR and IVDR:
Ensure clinical evidence and patient safety
The DSV rejects provisions that would lead to a lowering of requirements for clinical evidence and patient safety. A clinical evaluation without sufficient clinical data constitutes a contradiction and endangers patient safety and quality of care.
At the same time, the DSV expressly welcomes the planned approaches for the early involvement of expert panels in the clinical development and evaluation strategy of medical devices. Structured scientific advice at early stages can help to define evidence requirements more clearly, align studies more effectively and avoid undesirable developments in the conformity assessment procedure.
The DSV therefore calls for:
- clinical evaluation of medical devices to be based, in principle, on robust clinical data. Non-clinical data may complement clinical data and may only replace them in very limited exceptional cases (Art. 61 MDR),
- clinical studies involving medical devices already placed on the market, when used outside their intended purpose, should remain subject to the MDR authorisation, transparency and supervisory requirements (Art. 62 MDR),
- the scrutiny procedure pursuant to Art. 54 MDR and Art. 50 IVDR not to be restricted but to be extended to further care-relevant high-risk medical devices, as these assessments constitute a central prerequisite for initiating EU HTA procedures and thus enable reimbursement decisions by health insurance funds,
- a waiver of own clinical investigations based on claimed equivalence to be permitted only if the clinical evaluation of the equivalent product is based on a clinical investigation demonstrably conducted in compliance with the MDR (Art. 61(5) MDR),
- regulatory sandboxes to be used exclusively with clear substantive safeguards and solely for the purpose of structured evidence generation (Art. 59b and 59c MDR / Art. 54b and 54c IVDR).
Limit special regimes for orphan, breakthrough and WET devices
The DSV expressly welcomes that product categories such as orphan devices, breakthrough devices and well-established technologies (WET) are explicitly regulated in the legal text for the first time. This increases transparency, legal certainty and the clarity of procedures. It is also acknowledged that targeted procedural facilitations are envisaged for these product categories to promote innovation and enable care for small patient groups.
However, these special regimes must not lead to a de facto lowering of patient safety. The fundamental requirements for clinical evidence and market surveillance must fully apply to these product categories as well, or exemptions must be limited to products for which application risks can largely be excluded.
The DSV therefore calls for:
- certification conditions and structured programmes for generating the necessary clinical data to close evidence gaps alongside market placement,
- regular reassessment of the benefit-risk profile, the evidence base and the relevance for care,
- maximum review periods of five years – both for (legacy) orphan and breakthrough devices and for other exceptional arrangements such as in-house products (e.g. Art. 5 and 120 MDR / Art. 5 and 110 IVDR).
Strengthen binding transparency in market surveillance and supply shortages
The DSV expressly welcomes the strengthening of transparency regarding supply shortages and the expansion of reporting and early warning systems. Early information on imminent or existing shortages is a key prerequisite for safe, coordinated and reliable supply of medical devices.
The DSV therefore calls for:
- mandatory publication and regular updating of reported data on supply shortages, in particular based on notifications pursuant to Art. 10a MDR / IVDR,
- the continued and strengthened publication of national derogations pursuant to Art. 59 MDR / Art. 54 IVDR,
- strengthened information flows in market surveillance: preventive and corrective measures by manufacturers (Art. 83 MDR / Art. 78 IVDR) must be communicated automatically, systematically and comprehensively to the competent authorities.
Ensure liability and patient rights consistently
Previous medical device scandals – in particular the PIP case – have shown that clear liability rules and sufficient financial coverage by manufacturers are indispensable for effective patient protection. The proposed deletion of these provisions constitutes a clear step backwards.
The DSV therefore calls for:
- maintaining and strengthening manufacturer liability,
- mandatory financial coverage of potential liability claims,
- maintaining joint and several liability of authorised representatives,
- introducing an EU-wide mandatory liability insurance for manufacturers.
Use digitalisation as an efficiency lever
The DSV expressly welcomes the digitalisation of documentation and evaluation processes as an opportunity for more efficient procedures, increased transparency and reduced administrative burden.
The DSV considers:
- digital procedures must be interoperable, versioned and machine- and human-readable,
- digitalisation must not lead to reductions in the depth of assessment or regulatory oversight.
About us
The German Federal Pension Insurance (DRV Bund), the German Social Accident Insurance (DGUV), the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), the national associations for statutory health and long-term care insurance funds at the federal level and the Social Insurance for Agriculture, Forestry and Horticulture (SVLFG) have joined forces to form the "German Social Insurance - Working Group Europe" (Deutsche Sozialversicherung Arbeitsgemeinschaft Europa e. V.) with a view to their common European policy interests. The association represents the interests of its members vis-à-vis the bodies of the European Union (EU) as well as other European institutions and advises the relevant stakeholders in the context of current legislative projects and initiatives. As part of the statutory insurance system in Germany, health and long-term care insurance with 75 million insured persons, pension insurance with 57 million insured persons and accident insurance with more than 70 million insured persons in 5.2 million member companies offer effective protection against the consequences of major risks of life.