The Future of EU Medical Technology Regulatory System

MedTech Europe submission to the European Commission’s Call for Evidence consultation on the MDR/IVDR simplification reform

Revision proposal is first step towards fixing Europe’s complex Medical Devices & Diagnostics rules

Revision proposal is first step towards fixing Europe’s complex Medical Devices & Diagnostics rules

MedTech Europe calls for dedicated pathways for breakthrough, orphan and paediatric devices

Recertification under the MDR and IVDR – Frequently Asked Questions

Greener, smarter healthcare: Electronic Instructions for near-patient tests

Greener, smarter healthcare: Electronic Instructions for near-patient tests

European Commission launches ‘Call for Evidence’ on the future of the Medical Devices regulation and In Vitro Diagnostics Regulation

Open letter to Commissioner Olivér Várhelyi: safeguarding availability and innovation in 2025 and beyond

Open letter to Commissioner Olivér Várhelyi: safeguarding availability and innovation in 2025 and beyond

Electronic Instructions for use (eIFU) for certain medical devices intended for lay users

Sampling under IVDR: MedTech Europe proposal for a more risk-based approach

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