Brussels, 16 December 2025 – The Association of the European Self-Care Industry (AESGP) welcomes the European Commission’s legislative proposal amending the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). This targeted revision of EU rules for medical devices and in vitro diagnostics aims to simplify applicable rules, reduce the administrative burden on manufacturers, and enhance the predictability and cost-efficiency of the certification procedure by notified bodies, while preserving a high level of public health protection and patient safety.
AESGP strongly supports the necessity and urgency of reforming and simplifying the existing medical device regulatory regime. In particular, AESGP endorses the following measures included in the proposal:
- Removal of the re-certification requirement;
- Extension of reporting timelines concerning periodic safety update reports;
- Reduction of scope for the requirements to provide a summary of safety and (clinical) performance (SS(C)P);
- Reduction of notified body involvement in conformity assessments of lower and medium risk classes;
- Establishment of a legal basis for structured dialogue between notified bodies and manufacturers;
- Expansion of possibility to use non-clinical data;
- Facilitation of digital labelling as well as digitalisation of documentation for conformity assessment procedure.
These targeted reforms represent an essential step towards a more efficient and sustainable system. However, AESGP emphasises that streamlining processes alone will not suffice. A deeper and more substantial reform of the governance system for medical devices is needed to ensure long-term effectiveness and sustainability.
About self-care medical devices
Self-care medical devices encompass a wide range of products commonly used for minor ailments such as colds, skin irritations, abdominal pain, as well as for contraception and prevention of sexually transmitted diseases. Examples include plasters, condoms, saline nasal sprays, lubricating eye drops, and dermal creams or gels. According to the latest IQVIA Consumer Health market research supported by AESGP, self-care medical devices account for 12.4% of the total self-care products market in value and 45% in volume, with the highest penetration in categories such as eye care, dressings, and incontinence devices. Approximately 20% of new product launches in self-care are classified as medical devices.
Oliver Hartmann, Regulatory and Legal Affairs Director of AESGP, said: “Today’s proposal is a welcome move towards a smarter, more predictable regulatory framework for medical devices in Europe. Simplification is critical for innovation and people access, but a more substantial governance reform must follow to make the system truly future-proof.”