The Future of EU Medical Technology Regulatory System

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

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

Just published: amending electronic Instructions for Use regulation for medical devices

European Medical Device Nomenclature required for Medical Device Regulation and In Vitro Diagnostic Regulation submissions

Leaflet: Towards a revised EU regulatory framework for medical devices

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