Europe – Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU)...

The work of Notified Bodies (“NBs”) in the Conformity Assessment and Certification of Medical Devices (MD) and In-Vitro Diagnostic Devices (IVD) continues to be a...

Europe – MDCG 2021-4 rev.1 – Application of transitional provisions for certification of class...

According to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR), as part of conformity assessment of class D in vitro diagnostic...

Europe – Notification of a Body in the framework of a technical harmonization directive

Body Name ISTITUTO SUPERIORE DI SANITA' Address Viale Regina Elena, 299 00161 - ROMA Country Italy Phone +39 06 49906146 Fax +39 06 49903150 Email roberta.marcoaldi@iss.it Website www.iss.it Body Number 0373 Last approval date 03/05/2016...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

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)....
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

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...
How the New Free From Claims Impact the European Cosmetics Space

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...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

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...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

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...

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