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...
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...
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...
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...
