Europe – New European MDCG guidance clarifies designation of Notified Bodies under MDR, IVDR
The European Commission’s Medical Device Coordination Group (MDCG) has published new guidance covering designation, re-assessment and notification of Notified Bodies (NBs) as well as...
Europe – The clock is ticking – MedTech Europe’s recommendations ahead of May 2025...
Class D IVDs are critical for public health. They mainly fall into two categories: a) those related to blood, cells, tissues or organ screening,...
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 – « Le risque d’une pénurie de dispositifs médicaux fait craindre une nouvelle...
Alors que la crise du Covid-19 n’est toujours pas terminée, gardons à l’esprit la première leçon qu’elle nous a apprise : l’anticipation est la clé...
UK – MHRA appoints first new UK Approved Body to certify medical devices since...
The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies,...
UK – NHS rolls out artificial pancreas in world first move
Tens of thousands of children and adults living with type 1 diabetes across England are set to receive an ‘artificial pancreas’ in a world-first...
UK – NICE recommends AI technologies for radiotherapy treatment planning
The recommendation aims to speed up the time taken to produce outlines of healthy organs, in order to help target cancer cells while avoiding...
Europe – TÜV SÜD Danmark ApS today received its designation as Notified Body 2443...
TÜV SÜD Danmark ApS today received its designation as Notified Body 2443 under Medical Device Regulation 2017/745 by the Danish Medicines Agency (DKMA). Notified...
UK – MHRA and international partners publish five guiding principles for machine learning-enabled medical...
The MHRA, FDA and Health Canada have today published five guiding principles for the development of PCCPs for MLMD manufacturers. These guiding principles aim to support...
UK – Medical devices: UK approved bodies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
