Brexit appears inevitable – and it seems UK MHRA will emulate New Zealand!

19 December 2019 | Arthur Brandwood | Director and Principal Consultant

Brexit

As the dust settles on the UK general election, it appears that Brexit is inevitable, it’s only a matter of short term timing and terms.

So what does this mean for Medical Device regulation in the UK?

Well, it’s clear that the requirements in the UK will remain the same as in Europe. The UK will continue to operate under current national rules which reflect the various device directives (MDD/IVDD and AIMD).

The MHRA will also be introducing new national regulations which mirror the new European MDR and IVDR, and on the same timetable.

The tricky part is that the UK Notified bodies will no longer be able to operate, and the MHRA does not have capacity to do product assessments itself for devices supplied in the UK. So how to square this circle?

It appears that the MHRA intends to emulate New Zealand.

It’s Reliance writ large : UK will accept a UK decision and assessment, under European law, while leaving the EU and having no input into those laws

Our Kiwi friends across the ditch here from Sydney are busily re-writing their national controls in a revamped NZ Medicines Act. It too will introduce full conformity assessment requirements for medical devices, very much along European lines. But like MHRA cousins “Up Over”, MedSafe will have no capacity to do assessments.

And the solution? Unilateral recognition of CE. New Zealand will accept a prior international review from Europe, US, Canada, Japan or Australia as evidence of suitable assessment for New Zealand Registration. MHRA isn’t going quite that far, but it is simply requiring any manufacturer wishing to supply in the UK to obtain a CE certificate from a Notified Body based in Europe.

That’s right – for supply in the UK, MHRA will require compliance to a European law, demonstrated though assessment by a European body, while leaving the EC and having no input into those laws.

One other important detail, the UK will implement European UDI requirements.

Separately, manufacturers will need to double up on authorized representatives, having both an EC Rep as now as well as a UK “Authorised Person” (which is an EC Rep with a British accent).

Postmarket reporting, UK clinical trials reviews and approvals and UK product registrations will all continue to operate under current UK arrangements.

So what to do?

  • You use a UK Notified Body, switch to a European one. The separate tribulations in Europe in re-designating enough Notified Bodies to MDR/IVDR means that manufacturers need to have this well underway anyway or accept being locked out of Europe (and the UK) for a year or two.
  • If you supply in the UK, find and appoint a UK Responsible person who is competent to carry out the representative responsibilities.
  • If you are currently using a UK EC representative, they should be able to function as a UK Authorized person, but you will then need to find a new EC Rep actually based in Europe outside of the UK.
  • Update your systems to make sure your processes cover duplicate reporting and registration requirements in the UK and Europe.

For more details, see the MHRA Brexit page

We offer deep support for navigating international regulatory processes. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Reach out today and start a conversation. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)

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