Consultancy publishes Brexit guide for healthcare companies

01 December 2020 Consultancy.uk 3 min. read

With so much still to be decided before the UK and EU finalise their protracted divorce, life sciences consulting firm Maetrics has released a concise guide summarising the known requirements for healthcare companies, to help them prepare for regulatory changes. In particular, firms will need to ready themselves for the certification of medical devices and products.

Despite the fact that the pandemic has pushed Brexit negotiations from the front pages in recent months, they are still ongoing, and time to secure a deal is fast running out. Combined with the effects of Covid-19, they will have a dramatic influence on Britain’s healthcare service for years to come. Maetrics is a consultancy dedicated to guiding life sciences companies through challenges related to quality, regulatory, and compliance, with services allowing clients to reach new efficiencies as well as business goals – and as such, it has released a guide for healthcare companies to help them cope with changes pertaining to Brexit.

Steve Cottrell, President at Maetrics, commented, “Our industry is facing a number of on-going regulatory pressures, and this makes strategic planning more critical than ever… Businesses should immediately begin to identify where more information is still needed, as well as potential areas of complexity. These information gaps can then be filled in and addressed efficiently as and when there are new developments.”

CE MARKING IN THE UK POST-BREXIT: A TIMELINE

Cottrell added that Maetrics’ aim with the new mini-guide was to provide an easily absorbed overview that will help with preparations for the UK’s upcoming certification – one of the key areas of focus for the consultancy’s paper. There will be new regulatory requirements in the UK from 1st January 2021 for medical devices and in vitro diagnostic devices to be placed on the market within the UK. These include the fact that products on the UK market will require a UK Conformity Assessment (UKCA) mark, with CE marks being phased out and no longer recognised in Britain by 1st July 2023.

CE marking is an administrative marking that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. The mark indicates that a product fulfils the requirements of relevant European product directives, as well as all the requirements of the relevant recognised European harmonised performance and safety standards.

At the same time, after Brexit, all medical devices on UK markets must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). The executive agency of the Department of Health and Social Care is responsible for ensuring that medicines and medical devices work and are acceptably safe. Deadlines have varying risk-based grace periods.

The report’s researchers added, “The ongoing pressures and increase in compliance requirements in the UK and EU markets is putting a strain on medical device manufacturers and regulatory authorities alike. Savvy medical device companies are seeking the support of external expertise to achieve rapid and reliable compliance within the current highly constrained timelines and the unusually complex regulatory landscape.”