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Draft statutory instrument published in respect of Northern Ireland

By December 8, 2023No Comments

The Department of Health and Social Care have laid a new draft statutory instrument before the House of Commons and the House of Lords on 14 November. Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023 (SI 2023) makes provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/746 of the European Parliament.

BIVDA have provided our initial understanding of this text below.

Please consult your own legal team before acting on any of this advice, as it is our own interpretation.

In summary, the draft regulations relate to the implementation of Regulation (EU) 2017/746 (EU IVDR) which since 26 May 2022 fully applied in Northern Ireland, under the terms of the Windsor Framework. This indicates that IVD devices in Northern Ireland must comply EU IVDR only and not UK Medical Device Regulations 2002 (MDR). This draft SI updates the existing legislation and make supplementary provision such as fees and enforcement, to ensure that the EU IVDR is fully implemented and can operate effectively in Northern Ireland.

Part 2 of this draft SI outlines the amendments to primary legislation such as the Human Tissue Act 2004, the Consumer Rights Act 2015 and the Medicines and Medical Devices Act 2021 to incorporate changes related to medical devices.

Amendments to secondary legislation are provided in Part 3. There are amendments made to the Medical Devices Regulations 2002, including changes related to revocation, transitional and saving provisions with respect to EU MDR, revocation of requirement to appoint a UK responsible person for placing IVD devices on the market or for performance evaluation. It extends to various other regulations concerning blood safety, waste electrical and electronic equipment, and market surveillance, making amendments to align them with the EU MDR and EU IVDR.

Part 4 amends the Medical Devices (Northern Ireland Protocol) Regulations 2021 and adds new Part 2A and Part 3A. It details the requirements of UKNI marking, legal representatives, contact persons, ethical review, arbitration, clinical investigations and performance studies under EU MDR and EU IVDR. Amendments are made to provisions related to fees and certificates, notified bodies, offenses, and enforcement.

Next Steps

This new legislation should come into force on the 28th day after the day on which they are made. It has been laid before the House of Commons and the House of Lords and will go through debates in each chamber. If it is approved, it will pass into law. This process expected to take 2-4 weeks to complete. However, this might be affected by upcoming Christmas.

If you have any questions in the meantime, please send these to regulatory@bivda.org.uk.

Please note: BIVDA is not in a position to give definitive advice on matters concerning the law and you should always contact your legal advisers on such matters. BIVDA does not accept any liability for any errors, omissions or misleading or other statements in this communication whether negligent or otherwise.

Tehelj