The UK’s Medicines and Healthcare products Regulatory Agency today released an update on what medtech and pharmaceutical companies can expect to see as the country begins to implement plans to split from the European Union.
The Brexit agreement implementation period is set to end on December of 2020, according to the notice, during which the country will continue to use CE Marking for regulating medical devices.
Industries based in the UK will not have to find an authorized representative in the EU markets, according to the notice, and notified bodies in the UK will “continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognized for both the UK and EU markets.”
The MHRA said that new rules coming as part of the EU Medical Devices Regulation will be implemented in the UK as well, as the changes are set to go into effect during the implementation period in May of 2020.
EU Regulations on in vitro diagnostics are not set to apply until May 2022, outside the implementation period, but the MHRA said that “elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements.”
New Clinical Trials Regulations are expected to also be implemented during 2020, and would “therefore apply to the UK under the terms of the time-limited implementation period,” according to the release.
The MHRA warned that if the clinical trial regulations are not in effect before implementation ends, “UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, so that researchers conducting clinical trails can plan with greater certainty.”
As for a full transfer of authority to UK licenses, the MHRA said it was uncertain and would be determined by negotiations.
“The timing of this will depend upon the outcome of negotiations on our future relationship with the EU, which we do not want to pre-judge. Whatever the outcome of negotiations, we will look to be pragmatic and support the sector,” the MHRA wrote.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
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