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Information about the new medical device regulatory systems that will apply in Great Britain and Northern Ireland has started to ramp up as expected, given the short time left to set up workable new structures.

The system that will apply in Northern Ireland has come under close scrutiny, due partly to the US President-Elect’s support for the EU, and the rejection by the House of Lords on 9 November of the government’s proposed Internal Market Bill – a device that would enable it to alter the terms of the EU Withdrawal Agreement, should there be no agreement on an EU free trade deal. 

And its sheer complexity.

Northern Ireland Update

Office for Life Sciences (OLS) senior policy advisor for international trade and medical devices Jess Kirby recently reminded stakeholders that the Medicines and Healthcare products Regulatory Agency (MHRA) will remain responsible for all goods on the Northern Ireland market, and for medical device post-market surveillance locally.

Devices trade from Northern Ireland to the rest of the UK will take place seamlessly, with no extra requirements or paperwork needed (“unfettered access”), she said on a recent medtech Brexit webinar. (Also see "50 Days To Brexit – And No Extension, Govt Warns UK Medtechs" - Medtech Insight, 10 Nov, 2020.)

For trade going the other way, there will be no tariffs on goods entering Northern Ireland. Devices and other goods entering the EU – or those that are at clear and substantial risk of doing so  ̶  via Northern Ireland will face tariffs. There will some extra processing of goods arriving in Northern Ireland, but there will be no new physical customs infrastructure and a policy of “de-dramatization,” said Kirby.

From 1 January, most medical devices, IVDs and custom-made medical devices will need to be registered with the MHRA before being placed on the Northern Ireland market. The EU Medical Device and IVD Regulations will apply locally, meaning that the CE marking will apply in Northern Ireland. UK approved bodies can conduct conformity assessments leading to the Northern Ireland UKNI mark, but this mark will need to accompany the CE mark on the device. Conversely, products carrying both CE and UKNI marks cannot be placed on the EU market.

More guidance on these themes has just been issued by the MHRA. 

UKCA, UKRP Updates

Among other points, Kirby 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;

  • Both the UKCA and CE marks can be placed on a device, as long as they are shown clearly and alongside each other, for the Great Britain market. Devices with both marks will be able to be placed on the UK market both before and after the 30 June 2023 transition deadline;

  • The CE UKNI mark is only to be placed on a product by a UK-based approved body that has carried out an assessment for the purposes of the Northern Ireland market;  

  • The UKCA mark will be able to be issued by designated conformity assessment bodies in any country with which the UK has a mutual recognition agreement;

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

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

  • UKRPs need no set qualifications or experience for the role, simply to be able to carry out a list of duties (as different to the requirements to become an EU Authorized Representative  ̶  AR). They do not have separate registration persons. They must be based in the UK;

  • From 1 January 2021, the name and address of the UKRP will be required on UKCA-marked device labeling (but not on the labeling of CE marked devices). The MHRA recommends that UKRPs are appointed as soon as possible – preferably before the end of this year, and well ahead of when their services will be called upon. They are required to provide their details when registering the products in line with the grace periods;

  • For manufacturers based outside the UK and EU, both a UKRP and an EU AR will be needed to access both markets. Only in Northern Ireland can a single entity satisfy the roles for both markets;

  • All devices in the UK must be registered with the MHRA as of next year – in accordance with the three risk class-based deadlines. The MHRA’s website issues updated information for industry, which can also be sought from device.registrations@MHRA.gov.uk on subjects such as grouping device registrations of different device classes;

  • The Global Medical Device Nomenclature (GMDN) must be used when registering products with the MHRA. The grace periods do not include class I devices and general IVDs, which are already required to be listed with the MHRA; and

  • UK manufactured medical devices already in circulation within the EU market, CE-marked by UK notifies bodies, “are considered valid on the market.” But new batches of the same product may not be placed on the EU market, as they would not be valid.

A shortened list featuring some of these requirements was published on 10 November (see reference above).

Not Yet EU-Reciprocated

The foregoing points suggest a relaxation of requirements regarding the dual marking of devices as far as the UK market is concerned, said the Association of British HealthTech Industries (ABHI). Association regulatory and compliance director Phil Brown believes that this type of relaxation  ̶  allowing the CE and UKCA markings to be present on devices used in the EU27 – is not reciprocated in Europe.

The same goes for the UKNI mark, which, like the UKCA mark, is not recognized in the EU. Information on this is still awaited, he told Medtech Insight.

Read also

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