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MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies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...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Implementation of medical devices future regime

On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom. The...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations...

In the case of implantable devices and class III devices, clinical investigations shall be performed, except if: — the device has been designed by modifications of...
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) - updated information

Switzerland – New organisational structure with separate Medical Devices Surveillance Sector

For the strategy period 2023-2026, Swissmedic’s objectives include making legal responsibilities for medical devices more visible and stepping up international collaboration in this area....

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