Labelling and packaging of human-use drugs after Windsor Framework agreement
Introduction The MHRA has issued new guidance on the labelling and packaging of medicinal products for human use for the UK (including Northern Ireland) following the agreement of the Windsor Framework. The Windsor Framework sets out the long-term arrangements for...
EU Medical Device Vigilance Reporting: FAQ
In our first article surrounding EU Medical Device Vigilance Reporting, we discussed medical device vigilance reporting requirements for IVD and medical device manufacturers. This article will address some frequently asked questions questions about vigilance reporting that we receive from clients.
Responsibilities of Importers and Distributors
MDR 2017/745, which was enforced on May 26th, 2021, expands the responsibilities of importers and distributors. This article will examine the revised responsibilities of the importer and the distributor under the new regulation