Publication ofRegulation (EU) 2023/607amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Publication of aQ&A on practical aspectsrelated to the implementation of Regulation (EU) 2023/607....
For detailed information and conditions of applicability of transitional provisions, please refer to the Regulation amending (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices published in March 2023. ...
1. European Union Medical Device Regulation (EU MDR) Intro 2. Classification of Devices 3. Explanation of Economic Operators 4. The General Safety and Performance Requirements (GSPR) 5. Requirements for the Technical File 6. Risk Management Requirements Unique to the EU MDR ...
Learn why the EU Medical Devices Regulation transition was extended, as well as how this impacts medical device manufacturers and service partners. READ MORE The Unique Language Challenges of IVDs and the EU IVDR The EU IVDR brings a myriad of language requirements similar to those for MDR. ...
Last week marked a significant development in the complex implementation of the new EU medical devices legislation, theMedical Devices Regulation(MDR) and theIn VitroDiagnostic Medical Devices Regulation(IVDR). At the request of the EU Member States’ Health Ministers, who ar...
It has been suggested that we are entering a new era in medical device regulation in Europe. This paper discusses the implementation of the European Medical Devices Directive (EMDD) in EU member states with a particular focus on the UK. Case studies are then presented of two models of ...
Devices placed on the EU market prior to 26 May 2022 with notified body certificate, may be placed on the market or put into service under the Directive until 26 May 2025. See graph below for a summary of the timeline of Regu...
Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union effective from 26th May, 2021. The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibiliti...
On 15 March 2023, the Regulation (EU) 2023/607 was formalised, which provides medical device manufacturers more time to certify medical devices to mitigate the risk of shortages. The amended regulation introduces a longer transition period for products already on...
BS EN 556-1-2024 Sterilization of medical devices — Requirements for medical devices to be designated STERILE Part 1: Requirements for terminally sterilized medical devices 医疗器械的消毒ーー医疗器械标识为无菌的要求第1部分: 终端消毒医疗器械的要求.pdf,B