Europe – MDCG 2024-5 guidance on content of the Investigator’s Brochure for clinical investigations...
When a sponsor of a clinical investigation shall submit an application according to article 70(1) of the MDR, the application shall be accompanied by...
Europe – MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical...
Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) shall be performed in line with the requirements of Article 76(2) of...
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...
Europe – Update : MDCG 2022-9 rev.1 – Summary of safety and performance template...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires
that the manufacturer shall draw up a summary of safety and performance (SSP)...
Europe – Study on the implementation of Article 17 of Regulation (EU) 2017/745 on...
Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic...
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...
Europe – NF EN ISO 20916 – Mars 2024 – Dispositifs médicaux de diagnostic...
Le présent document définit les bonnes pratiques pour la planification, la conception, la conduite, l'enregistrement et l'établissement du rapport d'études des performances cliniques menées...
Europe – Request for a scientific opinion on risks for the health associated to...
Article 51(1) of Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council...
UK – MHRA warns of unsafe counterfeit anti-choking devices
The Medicines and Healthcare products Regulatory Agency (MHRA) is warning the public not to buy counterfeit or unbranded anti-choking devices as they do not...
Europe – Recent ECJ ruling could lead to standards development tumult
Earlier this month, the European Court of Justice (ECJ) ruled there is “an overriding public interest” for the European Commission (Commission) to disclose harmonized...
