USA – FDA recognizes new medical device sterilization standards
Amid a regulatory effort by the US Environmental Protection Agency (EPA) to limit the use of ethylene oxide (EtO), the Food and Drug Administration...
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...
Europe – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607...
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional
provisions for certain...
USA – FDA warns device makers for GMP issues, unauthorized uses
The US Food and Drug Administration (FDA) recently warned a hemodialysis manufacturer for marketing their products without submitting a premarket notification for one of...
Europe – European Commission approves updated regulation to ease contact lens UDI requirements
The European Commission has agreed to amend the EU Medical Device Regulation (MDR) to ease the Unique Device Identifier (UDI) requirements for certain products,...
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...
France – Laurence Comte-Arassus élue présidente du Snitem
L’assemblée générale ordinaire du Snitem (Syndicat national de l’industrie des technologies médicales) s’est tenue le mardi 27 juin 2023 à la Chambre de commerce...
Europe – Add 1 – MDCG Position Paper on the application of Art.97 MDR...
The position paper MDCG 2022-18 was published in December 2022 to provide a
uniform approach to the application of Article 97 of Regulation (EU) 2017/745...
France – Sécurisation des prescriptions: Vidal décroche le marquage CE classe IIb pour son...
Le groupe Vidal est le "premier acteur français" à obtenir le marquage CE classe IIb pour son logiciel de dispositif médical (DM) d'aide à...
USA – Medtech groups warn EPA of ‘devastating’ impact of proposed EtO rules
Two proposed regulations to limit the use of ethylene oxide (EtO) and the facilities that use the sterilizing agent could have a “devastating” impact...
