UK – Software and Artificial Intelligence (AI) as a Medical Device
Software (including AI) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices...
UK – New action to tackle ethnic and other biases in medical devices
Plan comes in response to independent report identifying the extent and impact of ethnic and other biases in the design and use of...
Europe – MDCG 2023-2 List of standard fees
Article 50 of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 46 of
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish...
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 – Votre avis sur l’extension de la période de transition des RDM et...
La Commission européenne va soumettre au Parlement européen et au Conseil une proposition d'amendement modifiant les règlements (UE) 2017/745 (RDM) et (UE) 2017/746 (RDMDIV) en ce...
UK – MHRA expected to launch recognition framework for devices
According to Richard Phillips, executive director of the Association of British HealthTech Industries (ABHI), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is...
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 – Amendement des normes IEC 60601 : les impacts sur l’évaluation des DM
Publiée pour la première fois en 1977, la norme IEC 60601-1 décrit les exigences générales de sécurité et de performances applicables aux dispositifs électro-médicaux....
Europe – Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing
The European Commission is set to assess how to streamline regulatory pathways for the biotechnology and biomanufacturing sector as part of a broader push...
Europe – European Commission Publishes Directive on the Liability of Artificial Intelligence Systems
On September 28, 2022, the European Commission published its long-promised proposal for an AI Liability Directive. The draft Directive is intended to complement the...
