New medtech regulations

Recertification under the MDR and IVDR – Frequently Asked Questions

Digital label for authorised representative and importer

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

MedTech Europe’s reaction to the President of the European Commission’s State of the Union Address

MedTech Europe calls for technical documentation sampling of In Vitro diagnostics to become more risk-based

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

Sampling under In Vitro Diagnostics Regulation: MedTech Europe proposal for a more risk-based approach

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