• Melita Ball

January 22, 2020 Blog Post

How the UK Plans to Regulate Medical Devices if There’s No Brexit Deal

Hello Readers!

This topic and content was curated from the EU website. An important read no matter where your business is. If there is a no-deal Brexit, the UK’s current participation in the European regulatory network for medical devices would end, and the MHRA would take on the responsibilities for the UK market that are currently undertaken through the EU system. This section provides further detail on how we propose the UK system would operate.

Conformity of Products

For a time-limited period, we will continue to allow devices to be placed on the UK market that are in conformity with the applicable EU Directive. Relevant labelling requirements will continue to apply including the requirement for products to carry a CE mark and devices which currently require conformity assessment by a NB must have a valid CE certificate.

If there’s a no-deal Brexit, UK-based NBs will no longer be recognised by the EU after Brexit, meaning the devices they have certified will no longer be in conformity with the applicable EU Directive. As such these products will not be able to be placed on the EU market.

To support the continuity of supply of products to the UK market, we will give UK-based NBs an ongoing legal status and continue to recognise the validity of certificates that they issued prior to exit day. This will allow products covered by certificates issued by UK-based notified bodies to continue to be placed on the UK market after exit day.

UK law will not require any changes to the labelling of affected products. Furthermore, the UK will continue to accept labelling in the English language, which includes information from other jurisdictions (such as Ireland), on condition that information complies with all UK requirements.

Clinical Investigations

The UK will continue to recognise existing clinical investigation approvals – both for regulatory and ethics approvals – and there will be no need to re-apply. UK clinical investigation applications will continue to be authorised by the MHRA and ethics committees as they are presently.

Market Surveillance of Devices

Currently, post-market safety data is shared across all members of the European regulatory network for devices (EU, EEA, Turkey and Switzerland), and any disagreement over the marketing of a device can be escalated through regulator forums such as the Medical Devices Coordination Group, and potentially through the European Commission and Court of Justice of the European Union (CJEU).

If there’s no deal, the MHRA would continue to perform market surveillance of medical devices on the UK market and be able to take a decision over the marketing of a device in the UK, regardless of the position of the European regulatory network, or any decision of the CJEU.

New EU Regulations

Through the no deal statutory instrument, which will amend the Medical Devices Regulations 2002, the UK will have a regulatory system in place on 1 February 2019, which will mirror all the key elements contained in Regulations 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic medical devices (IVDR) and which will be brought into force in line with the transitional timetable being followed by the EU for the full application of those two Regulations.

Registration of Medical Devices on the UK Market

After exit day, all medical devices, active implantable medical devices, in vitro diagnostic medical devices (IVDs) and custom-made devices will need to be registered with the MHRA prior to being placed on the UK market.

Thoughts? Please comment below …

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