The following devices in Great Britain (England, Wales and Scotland) need to be registered with the MHRA under existing arrangements: Class I medical devices, IVDs, custom-made devices.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products. This guidance will apply from 1 January 2021 in line with the Human Medicines Regulations.
The European Commission’s Medical Device Coordination Group (MDCG) released its much-anticipated guidance on the classification of in vitro diagnostics (IVDs).
The UK has left the EU, and the transition period after Brexit comes to an end this year. Stakeholders need to get ready for new rules from 1 January 2021.
As of 1 September 2020, all medical devices used by care providers must have a CE marking. Since mid-March, due to shortages caused by the corona pandemic.
In line with a reduction in restrictions, the inspectorate plans to resume an on-site UK risk-based GxP inspection programme starting in September.
The European Commission has published an overview of the information that will be publicly available under EP and Council Regulation (EU) 2017/745 on medical devices.
On the 9th of July 2020 the European Commission has adopted a Communication to help national authorities, businesses and citizens prepare for the inevitable changes.
Due to the corona crisis the majority of the clinical trials conducted were put on hold. Since the Dutch Government currently gradually reduces the restrictive measures.
The European Commission’s Medical Device Coordination Group (MDCG) issued guidance explaining the process for transitioning CE certificates
The AEMPS extends the deadline until May 25, 2021 for the adequacy of the labeling and the instructions for use of medical devices as a consequence of the changes made by Brexit