Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC
Posts tagged as “MDCG”
MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019
The next meeting of the MDCG is schedule for 20 June 2019. Some guidance are up for endorsement: Vigilance: Manufacturer Periodic Safety Report (MPSR) form…
MDCG 2019-6 Questions and answers: Requirements relating to notified bodies
MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI
MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
MDCG 2019-3 Interpretation of Article 54(2)b
Meetings of MDCG and subgroups – 2019
MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers