Europe – EU Update: Current State of Medical Device Regulations
Amending legislation published to extend the transition of legacy IVDs and roll out EUDAMED
Regulation 2024/1860 was officially released to extend the transition time for legacy...
Europe – New pilot programme to support orphan medical devices
EMA has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU)....
Europe – Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewing...
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2017/745 of the European Parliament and of...
Europe – Medical device competent authority statement on the status of the EU regulatory...
National Competent Authorities have endorsed a consensus statement and shared it with the European Commission on the status of the EU regulatory framework for...
Europe – Règlements européens relatifs aux dispositifs médicaux et de diagnostics in vitro :...
Le 10 juillet 2024, nous avons accueilli à Saint-Denis nos collègues européens dans le cadre d’un atelier de travail sur les dispositifs médicaux organisé...
Europe – Regulation (EU) 2024/1689 of the European Parliament and of the Council of...
The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework in particular for...
Europe – Regulation (EU) 2024/1860 of the European Parliament and of the Council of...
Regulations (EU) 2017/745 (3) and (EU) 2017/746 (4) of the European Parliament and of the Council establish a regulatory framework to ensure the smooth functioning of the internal market...
Europe – MDCG 2020-16 Rev.3 – Guidance on Classification Rules for in vitro Diagnostic...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
UK – Medical devices: UK approved bodies
Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
Europe – MDCG 2021-5 Rev. 1 : Guidance on standardisation for medical devices
The EU legislative framework on medical devices currently consists of two Regulations adopted and entered into force in 2017:
• Regulation (EU) 2017/745 on medical...
