Medical technology regulations

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

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

MedTech Europe joins the European Framework for Advanced Medical Technology Evaluation and Follow-up Stakeholders Forum

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

Revision of Standardisation Regulation 1025/2012

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

MedTech Europe: practical guide for the use of European Medical Device Nomenclature

Leaflet: Towards a revised EU regulatory framework for medical devices

Towards a revised EU Regulatory Framework for medical devices

MedTech Europe responds to the European Commission’s targeted evaluation of Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

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