Europe – Lancement d’un groupe de travail européen sur l’évaluation des DM numériques (ANS)
PARIS (TICpharma) - Un groupe de travail européen sur l'évaluation des dispositifs médicaux (DM) numériques a débuté ses travaux en vue de "parvenir à...
Europe – European Commission Proposes Extending MDR, IVDR Transition Periods
At the EPSCO Health Council on 14 June 2022, Health Ministers expressed their concerns that severe challenges related to the implementation of Regulation (EU)...
Europe – Un nouveau organisme notifié au titre du règlement (UE) 2017/745
Body Name - HTCert (Health Technology Certification Ltd)
Address - Jacovides Tower 81-83 Grivas Digenis Avenue
1090 Nicosia
Country - Cyprus
Email- info@htcert.com
Website - www.htcert.com
Body Number - 2803
Last approval...
Europe – GUIDANCE on the content and structure of the summary of the...
This document is intended to provide Commission guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of...
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...
UK- Wearable technology to be offered to thousands with type 1 diabetes in UK
The condition affects around 270,935 people in England and 16,090 people in Wales.
The National Institute for Health and Care Excellence (NICE) has published final...
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 – MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations
Software has become an increasingly important part of the medical device landscape. It is
estimated that one in four medical devices either incorporate medical device...
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 – 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...
