Team NB position statement on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical Device Quality…
Posts published in “In Vitro Diagnostic Medical Device Regulation IVDR”
M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization…
Manufacturer incident report 2020 Manufacturer incident report for importing XML file with Adobe Professional 2020 Changelog file 2020
Ongoing Guidance development within MDCG Subgroups
Privacy statement – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Planned meetings of Medical Device Coordination Group (MDCG) and subgroups in 2020
State of play of joint assessments of Notified Bodies in the medical device sector
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
COM(2020) 93 – Identifying and addressing barriers to the Single Market SWD(2020) 54 – Business Journey on the Single Market: Practical Obstacles and Barriers COM(2020)…
So new draft agendas were published for some of the next MDCG meetings. Here are some topics that caught my attention (besides the important general…