The European medical devices market, being the second largest in the world, is majorly driven by a growing patient population, technological advancements, and increasing healthcare expenditure. However, when it comes to expanding the medical device business into the European geography, a complex web of regulations and recent geopolitical changes adds an extra layer of challenge.

Europe is the busiest region with evolving Regulatory landscape, as Brexit compliance, application of the EU MDR, transition to UKCA marking, and upcoming IVDR deadline take the front seat. All these dynamics have kept the Regulatory professionals on their toes. The UKCA mark came into effect on January 1, 2021, and the CE marked devices have a grace period until July 31, 2023, to eventually transition to the UKCA mark.

Based on the European Commission’s (EC) proposal on facilitating the movement of goods from Great Britain to Northern Ireland in October 2021, the Commission has now set up plans to maintain the medicines’ supply in specific markets post-Brexit.

Brexit has brought about significant changes in the EU and the UK in terms of regulations affiliated with cosmetics, pharmaceuticals, personal care products and medical devices. The UK decided to leave the EU in 2016 and officially left the trading bloc on Jan 31, 2020. Both countries decided to keep a few things unaltered until Dec 31, 2020.

Significant Changes taken place in the Cosmetics Industry in the UK 2021

Some significant changes have taken place in the UK post-Brexit, which are listed below.

Following the Brexit on 31 December 2020, Great Britain is no longer part of the EU scheme for regulating biocidal products. The existing EU Biocidal Products Regulation (EU BPR) has been transformed to Great Britain Biocidal Product Regulation (GB BPR). However, most aspects of the EU BPR will continue in the same way under the GB BPR.

Here are a few updates on the GB BPR:

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The withdrawal of the United Kingdom from the European Union had many concerns. One of them being Regulatory Submissions. To smoothen the submissions process, the EU and the UK have set up a clear set of rules. Many of them are related to the existing and new marketing authorisation applications (MAAs) for CAPs, DCP and MRP, Batch testing, QP Certification, etc. Let us have a look at what Brexit means for the EU and the UK Regulatory Submissions. Here is a clear-cut Brexit impact summary that has recently been published by a consulting firm.

As you may know, January 1, 2021, has called off the 11-month long post-Brexit transition period. This also marked the deadline for the United Kingdom (UK) based food and beverages manufacturers to implement their product labeling changes. With regards to the changes, on November 5, 2020, the UK Department for Environment, Food & Rural Affairs (Defra) has published an update related to the information to be mentioned on the label of food products that are intended for sale in the UK and the European Union (EU), particularly in Northern Ireland.

Being one of the crucial export sectors of the UK, the Chemicals industry could get hit hard due to Brexit. British companies are already competing with the American and the Asian markets and are under tremendous pressure in battling higher R&D costs.

Since the commencement of Brexit transition timelines, the entire medical devices community is underway to understand its impact on future trade and Regulatory relations between the European Union (EU) and the United Kingdom (UK). As noted, the UK left the EU on January 31, 2020, as per the Withdrawal Agreement between both the countries. The agreement brings up a transition period until December 31, 2020, which intends to give time for national administrations, businesses and citizens to get ready for the significant changes due to the Brexit.

It is a known fact that the UK has officially left the European Union (EU) on January 31, 2020 and it is in the transition period until December 31, 2020. During the transition period, all the pharmaceutical companies in the UK must abide by the EU pharmaceutical law. In March 2020, EMA also updated Brexit-related guidance for the benefit of the pharmaceutical companies. As per the guidance, the following entities can be located in the UK until the year-end: