Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and…
Posts published in “Medical Devices Directive – MDD”
Manufacturer incident report 2020 Manufacturer incident report for importing XML file with Adobe Professional 2020 Changelog file 2020
MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified…
REGULATION (EU) 2020/561 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the…
Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
Joint Action on Market Surveillance of Medical Devices (JAMS) Stakeholder Conference Held In Brussels On Dec. 12th 2019
Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC
How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities
How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities
So after reviewing some concepts for a Clinical Evaluation training I gave this week, some people asked me about sources of literature on how to…