NEW YORK – The UK Medicine and Healthcare Products Regulatory Agency (MHRA) this week issued a new guidance on how the country will regulate in vitro diagnostics after Jan. 1, 2021, when the transition period following the UK's exit from the European Union ends.
The UK left the 27-member block earlier this year and the framework for regulating IVDs after Brexit has remained unclear. According to MHRA, IVDs in the future will require certification in Great Britain, defined as England, Scotland, and Wales, while companies will still be able to sell tests in Northern Ireland under existing EU IVD regulations.
As laid out in the guidance, MHRA will continue to recognize CE marks until June 30, 2023. All companies wishing to place IVDs on the UK market will require registration with MHRA after Jan. 1, 2021 but will still be able to sell CE-IVD marked products for the next two and a half years. There will be a year-long grace period for registering class I devices, which covers most IVDs.
Since the EU's new Medical Device Regulation and IVD Regulation (IVDR) will come into effect post-transition, in May 2021 and May 2022, respectively, they will not apply in the UK. Instead, companies that wish to sell IVDs in Great Britain after July 1, 2023, will need to obtain a new marking called a UK Conformity Assessed mark, or UKCA. This mark will not be automatically recognized in EU countries, MHRA noted, meaning companies that wish to sell in the UK and the EU will have to seek both a UKCA and CE-IVD mark in the future.
MHRA will from Jan. 1, 2021 rely on organizations, called approved bodies, to oversee the conformity of IVDs with regulations in Great Britain during and following the transition to the new UKCA regime. MHRA noted that existing notified bodies certified by the government to assess the conformity of tests under the current EU IVD Directive (IVDD), will have their designations rolled over and will not need to reapply for designation as approved bodies to issue UKCA marks after the transition.
The new regulatory framework does not apply in Northern Ireland, which will transition with the rest of the EU to the IVDR in 2022. Companies in Northern Ireland will continue to have their tests certified under the IVDD and IVDR once they come into effect.
The UK left the EU in January. In February, the government passed a bill to guide future regulations in the country of 68 million people, which remains one of the largest markets for IVDs in Europe and is the home country of numerous IVD manufacturers in the region.