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...
Europe – MedTech Europe signs joint healthcare statement highlighting how the AI Act can...
In the joint statement, healthcare stakeholders representing patients, healthcare professionals and industry, share their views on how the AI Act can give citizens the...
UK – MHRA issues new guidance on the use of life saving adrenaline auto-injectors
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during...
