medicines-medical devices-regulatory affairs
The Medical Device Coordination Group (MDCG) has published the following updates: Guidance No About the guidance MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnosticmedical devices (IVDs) This document outlines the general principles of clinical evidence…
The following commission implementing decisions on the harmonised standards for medical devices drafted in support of the Medical Devices Regulation (EU) 2017/745 (MDR) of the European Parliament and of the Council have been published thus far: Commission Implementing Decision (EU)…
The European Commission has published a comprehensive study report on medicines shortages in the EU. A very brief overview of the study is available here. About medicines shortages in the EU Medicine shortages present a growing problem for many EU/EEA…
The European Parliament has adopted a report calling for increased use of off-patent medicines in Europe to improve patient access, highlighting lessons learned during the Covid-19 pandemic and urging the European institutions to address them directly in future healthcare policy…
The EU Commission has published a public consultation on the revision of the EU’s pharmaceutical legislation. This is part of its work to create a future-proof and crisis-resilient regulatory framework for the pharmaceutical sector and the latest step towards an…
The European Medicines Agency has recently published a 29 page Reflection Paper on Good Manufacturing Practice (GMP) and Marketing Authorisation holders (MAHs). Whilst it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products…
The European Medicines Agency (EMA) is consulting the public on draft common EU standards for electronic Product Information (ePI). You can read more about ePI here. About the draft common standard for ePI The draft EU common standard for ePI…
Last updated: 23 August 2022 This post is an attempt to facilitate understanding of the basics of the UDI system, an EU identification system for medical devices introduced in the Medical Devices (EU) Regulation (EU) 2017/745 (MDR) and the In…