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…
Posts published in June 2019
Team-NB published a press release regarding the survey run among its members to analyse the certificates being issued
Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs)…
Medical devices: Implementation of Regulation (EU) 2017/745 on medical devices (MDR)- Information from the Irish and German delegation
MDCG 2019-6 Questions and answers: Requirements relating to notified bodies
EMA – Consultation on draft guideline on quality requirements for medical devices in combination products
Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons (DCBs) and Drug-Eluting Stents (DESs) to the MHRA