Targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities

The European Commission is conducting a targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities. About Commission Implementing Regulations A Commission Implementing Regulation is a legally binding act of the European Union. It is…

Read More

CMDh updates August 2021

CMDh Minutes for the meeting on 22-23 June 2021 The minutes for the above meeting are now available here (24 page document) and the following items are included: 1. Brexit (pg 7) The CMDh discussed a topic included under 8.3…

Read More

MDCG updates August 2021

The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number Notes MDCG 2021- 23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746…

Read More