Europe – MDR/IVDR survey shows NBs have increased capacity
A recent survey published by the European Commission shows a promising trend for devices and diagnostics transitioning to Medical Device Regulation (MDR) and In...
UK – Implementation of medical devices future regime
On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom....
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...
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...
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...
Europe – Pediatricians push for urgent action to stop MDR from disrupting medical device...
The European Academy of Paediatrics (EAP) has warned urgent action is needed “to secure continued access to essential medical devices for children and for...
Europe – Règlement d’exécution (UE) 2023/1194 de la Commission du 20 juin 2023 modifiant...
Est paru le 21 juin 2023 au Journal Officiel de l’Union Européenne le Règlement d’exécution (UE) 2023/1194 modifiant les dispositions transitoires établies dans le Règlement...
Europe – EUDAMED user guide : Economic Operators – Actor module
EUDAMED is the IT system developed by the European Commission to implement the EU
medical devices regulations:
Regulation 2017/745 on medical devices
Regulation 2017/746 on in vitro...
