Medical technology regulations

Implementing Act on Notified Bodies requirements: a pragmatic first step to restore predictability

European Commission’s high-level conference on medical devices: innovation and patient safety

Implementing act on uniform application of the requirements for Notified Bodies (Annex VII)

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

Medtech Europe, LSMA and VDGH warn of serious impact of proposed changes to EU Implementing Regulation 2021/632

Risk based approach to Post-Market Clinical Follow-up (PMCF)

Greener, smarter healthcare: Time to digitalise near-patient testing

Joint industry paper calling for digital label for importer and authorised representative information

Recertification under the MDR and IVDR – Frequently Asked Questions

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