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Strasbourg

Tomorrow marks 50 days to the end of the UK’s transition period out of the EU. “Tunnel” negotiations have intensified this week between the European Commission and UK government towards creating a bilateral free trade agreement (FTA), which most commentators said should have been on the table by mid-October to allow time for European Parliament ratification and other EU clearances.

One week ago, the Office for Life Sciences (OLS) observed that many businesses still seemed unprepared for all eventualities by the 1 January 2021 Brexit date.

Some 40% of businesses think the transition will be extended, the OLS’s Alex McLaughlin told a British In Vitro Diagnostics Association (BIVDA) meeting on 4 November. “It really will not be extended, and you need to need to plan for everything to change as of 1 January,” said McLaughlin, head of international trade and medical device regulation at the OLS, as he repeated the position of Prime Minister Boris Johnson.

McLaughlin also noted that intensive negotiations were ongoing to include the UK in the EU’s Horizon Europe research program, possibly as part of a broader FTA with the EU; or with the UK treated as a third party for this purpose. His view, one week ago, was that it should ultimately be possible to close a deal on all of the non-politicized areas of an EU deal in time.

Whether the UK’s official stance on a hard Brexit is modified by the arrival in office of a pro-EU US President in Democrat Joe Biden remains to be seen. The UK also needs to factor in the progress it needs to make on a US deal. So far, the UK’s biggest success in post-EU deal terms has been with Japan; that deal needs to be ratified by UK parliament and the Japanese National Diet. It is largely a copy-over of the Japan-EU deal, with additional agriculture and digital provisions.

As to a UK-US deal, the OLS said it was confident that whoever was in the White House, the prospects for a US deal were positive after six hours of bilateral talks the week before. There is interest and willingness on both sides, “and that is good for business in medical devices across the UK and the US,” including in the ways the regulatory authorities can collaborate.

McLaughlin noted that the US health care talks were not being politicized, and were being led by career officials.

As to the Australia and New Zealand trade deals, these remain at very early stages. There is a strong political will on both sides and there have been exploratory talks on life sciences which will be fleshed out in the coming two to three months, said the OLS official.

More MHRA Guidance For Medtech Regulatory Systems In UK

The OLS also updated UK medtechs on the new procedures for UK market access after the UK finally leaves the EU. More guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) was issued on 4 November on regulating devices after 1 January, stressing the different rules that will apply in Great Britain and Northern Ireland in the UK’s post-EU phase.

Jess Kirby, OLS senior policy advisor for international trade and medical devices, had earlier brought the BIVDA meeting attendees up-to-date on several important areas, notwithstanding the possibility that EU-UK medtech mutual recognition agreement (MRA) provisions might yet be decided. 

Among other points, she noted that:

  • All UK notified bodies (approved bodies in the UK) will be able to issue UKCA marks for Great Britain, and CE UKNI marks for Northern Ireland in certain circumstances;

  • The UKCA mark can be issued by designated conformity assessment bodies in any country with which the UK has an MRA;

  • Manufacturers of class I medical devices and general IVDs can self declare for the UKCA marking for the for GB market; class 1 sterile and measuring devices will need assessment by an approved body to be placed on the GB market;

  • All devices used in the UK must be registered with the MHRA, for which a UKRP might be needed; and

  • From 1 January, the GMDN will be used when registering products with the MHRA, respecting the permitted grace periods. These do not apply to class I devices and general IVDs, which are already required to be listed with the MHRA.

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