The current Regulatory scenario for medical devices in the United Kingdom (UK) is governed by the Medical Devices Regulations 2002 (SI 2002 No. 618, as amended), also known as the UK MDR 2002. This framework was originally based on the European Union (EU) Directives, but following the UK’s exit from the EU, there have been changes to how medical devices are regulated in Great Britain (GB), comprising England, Wales, and Scotland.
Here are the key points with respect to the current Regulatory scenario for medical devices in the UK:

It is well known that from January 1, 2021, medical devices to be placed on the UK market are obliged to follow a new Regulatory regime. Currently, the UK market is a witness to many Regulatory changes, with the impact of Brexit. The UK’s existing Regulatory Authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), has taken over the European Union (EU) responsibilities, ultimately changing the UK regulations.

On January 31, 2020, the United Kingdom (UK) officially left the European Union (EU) making the Brexit come alive. In the light of Brexit, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have released certain Regulatory guidelines to ensure both pharmaceutical and medical device manufacturers are ready for the transition period. Here are the industry-wise key insights to be aligned with:

With each year, Life Sciences industry is transforming in unpredictable ways, of course it is to better the end-user’s safety. The industry is progressing with technological advancements and the health authorities are equally striving to upgrade the existing Regulatory frameworks to align with market requirements. The Agencies are considering the industry point of view, too, to simplify the regulations. We have seen many such regulations in 2018. But what’s there in 2019?