Medical Devices - Regulatory Updates - January Vol. 1
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.
Medical Devices - Regulatory Updates - December Vol. 1
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.
Medical Devices - Regulatory Updates - November Vol. 2
The European Commission’s Medical Device Coordination Group (MDCG) released its much-anticipated guidance on the classification of in vitro diagnostics (IVDs).
Medical Devices - Regulatory Updates - September Vol. 2
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.
Medical Devices - Regulatory Updates - September Vol. 1
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.
Medical Devices - Regulatory Updates - August Volume 2
In line with a reduction in restrictions, the inspectorate plans to resume an on-site UK risk-based GxP inspection programme starting in September.
Medical Devices - Regulatory Updates - August Volume 1
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.
Medical Devices - Regulatory Updates - July Volume 2
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.
Medical Devices - Regulatory Updates - July Volume 1
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.
Medical Devices - Regulatory Updates - June Volume 2
The European Commission’s Medical Device Coordination Group (MDCG) issued guidance explaining the process for transitioning CE certificates
Medical Devices - Regulatory Updates - June Volume 1
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