The debate over the revision of the EU Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) has recently intensified following the publication of position papers by MedTech Europe and AESGP, representing respectively the medical device and self-care sectors. Both associations broadly welcomed the European Commission’s proposal to simplify the current framework, while also highlighting critical issues and proposing targeted amendments.
MedTech Europe’s proposals
MedTech Europe positively assessed measures such as the removal of mandatory five-year renewals for CE certificates, the introduction of risk-based periodic reviews, and the increased digitalisation of technical documentation and conformity declarations. The association also called for stronger international regulatory cooperation, including the EU’s participation in programmes such as the Medical Device Single Audit Program (MDSAP), to improve global competitiveness and support exports.
The organisation further supported dedicated pathways for breakthrough and orphan technologies, while calling for clearer integration of AI Act requirements into the MDR/IVDR framework through a single conformity assessment process. However, MedTech Europe strongly opposed the possible reuse of single-use devices, arguing that such an approach could undermine patient safety.
AESGP calls for proportionality for low-risk devices
AESGP, representing the self-care medical device sector, focused primarily on the need for proportionality and legal certainty for low-risk products. The association criticised the proposed extension of conformity assessment scrutiny procedures to all medical devices regardless of risk class, warning that it could create unnecessary administrative burdens without significant safety benefits.
The organisation also raised concerns regarding the procedures used to determine whether products fall within the scope of the MDR and requested the removal of references to pharmaceutical legislation for substance-based devices. AESGP further advocated extending electronic instructions for use to patients as well as healthcare professionals and supported the introduction of a Class I category for low-risk software, while calling for clarification on rules governing software used in critical clinical situations.
