Proposal for a Regulation - Targeted revision of the EU rules for medical devices and in vitro diagnostics

ENEN

• INT/1116 – Medical devices and in vitro diagnostics / Simplification

Key points

The EESC:

• welcomes the Commission’s proposal to simplify and streamline the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) while safeguarding patient safety, public health protection and trust in the regulatory system;
• stresses that simplification must ensure legal certainty, predictable certification outcomes and harmonised practices across Member States, avoiding divergences among notified bodies and protecting SMEs and micro-enterprises from uncertainty;
• underlines that digitalisation of conformity assessment and audits must avoid duplication of requirements and additional costs, particularly for SMEs, workers and healthcare staff, and must be supported by clear guidance, training and technical assistance;
• insists that simplification must not be undermined by increased notified body fees and that post-market surveillance and vigilance systems must be strengthened as a key compensatory mechanism for more flexible pre-market requirements;
• supports innovation-friendly regulatory pathways for breakthrough and orphan devices while ensuring transparency (including through EUDAMED), and calls for the systematic involvement of social partners, healthcare professionals and civil society in monitoring implementation and impacts.

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