Europe – LNE-GMED UK désigné dans le cadre de la réglementation britannique relative aux...

En décembre 2023, LNE-GMED UK, filiale GMED du groupe LNE a été accrédité par UKAS (United Kingdom Accreditation Service) au titre de la norme...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

Uk – UK approved bodies launch Team-AB as MHRA gears up for new medtech...

Approved bodies (AB) in the UK have come together to launch the UK Association for Medical Device Approved Bodies (Team-AB). It plans to lobby...

Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and...

Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented...

Europe – Experts outline challenges of combination products in Europe

Combination products are increasingly important, increasingly complex and are increasing the pressure on the European regulatory network, according to Thomas Wejs Møller, senior director...
SCCS - Final Opinion on Solubility of Synthetic Amorphous Silica (SAS)

Europe – MDCG endorsed documents and other guidance

MDCG a publié 5 nouveaux documents concernant les conseils de vigilance spécifiques aux dispositifs (DSVG). Le document initial est "MDCG 2024-1 Guidance on the...

Europe – User guide for micro, small and medium-sized enterprises

This guide has been prepared for micro, small and medium sized enterprises (‘SMEs’) operating in the pharmaceutical sector. Its aim is to facilitate understanding...

Europe – Commission proposes measures to improve the availability of in vitro diagnostics

Today, the European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. With this...

Europe – Regulation (EU) 2023/1542 concerning batteries and waste batteries, amending Directive 2008/98/EC and...

The Communication of the Commission of 11 December 2019 on ‘The European Green Deal’ (the ‘European Green Deal’) is Europe’s growth strategy that aims...

Europe – Overview of language requirements for manufacturers of medical devices

The Commission and Member States have created MDR and IVDR tables. These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

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...

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