Since Brexit, the UK has been subject to two separate regulatory frameworks on medical devices. Great Britain is subject to the Medical Devices Regulations 2002/618 (UK MDR) - essentially a lightly amended version of the EU's old Medical Device Directive framework. Meanwhile, under the terms of the Northern Ireland Protocol, Northern Ireland is subject to the EU's new medical device regulatory framework, which consists of the Medical Device Regulation 2017/745 (EU MDR) and In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR).
This means that manufacturers and distributors of medical devices and in vitro diagnostics (IVDs) which do business throughout the UK must comply with two separate regulatory frameworks. Understandably, this can cause some headaches. This is particularly so where a manufacturer wishes to sponsor a clinical investigation or a performance study with sites in both Great Britain and Northern Ireland. The EU MDR and IVDR contain dramatically more specific and exacting rules on the conduct of clinical investigations and performance studies than those found in the UK MDR.
For example, a sponsor of a clinical investigation or performance study in Northern Ireland who is established outside of Northern Ireland or the EU must appoint a legal representative. A legal representative must be established in Northern Ireland or the EU and is responsible for ensuring the sponsor's compliance with the EU MDR or IVDR. No equivalent exists under the UK MDR for clinical investigations or performance studies conducted in Great Britain.
This particular rule creates irritating additional bureaucracy for a sponsor of a clinical investigation or performance study throughout the UK who is established in Great Britain or another country outside of the EU and Northern Ireland. Notwithstanding that the UK is notionally a single jurisdiction, such a sponsor is required to appoint a legal representative in Northern Ireland or the EU. At best, this involves paying administrative fees to a third party to act as little more than a post box. At worst, a legal representative can be particularly risk-averse and concerned about their potential liability for non-compliance by the sponsor. This can result in the legal representative demanding active input on the management of the investigation or study, and in some cases threatening to terminate the relationship with the sponsor if the sponsor does not act on the legal representative's advice.
Pursuant to its powers under the EU MDR and IVDR, the MHRA has now amended its guidance on clinical investigations and performance studies conducted in Northern Ireland in an effort to address this particular issue. From now on, a sponsor conducting a clinical investigation or performance study solely in Great Britain and Northern Ireland will not be required to appoint a legal representative for Northern Ireland, provided that: (a) the sponsor is either established in Great Britain or has appointed a legal representative established in Great Britain to act in respect of Northern Ireland; and (b) the sponsor has appointed a contact person in Northern Ireland to be the addressee for communications under the EU MDR or IVDR.
This is a small change. It will make life a bit easier for a sponsor of clinical research who is established in Great Britain. However, for sponsors established outside of Great Britain, this makes little difference. A sponsor established in Northern Ireland or the EU was already not obliged to appoint a legal representative, so this change makes no difference. More frustratingly, a sponsor established outside of the UK or EU will still be obliged to appoint a legal representative, albeit they will have a slightly wider pool to choose from as they will be able to appoint a legal representative established in Great Britain.
Under the EU MDR and IVDR, it is within the MHRA's power to do away entirely with the requirement to appoint a legal representative for clinical investigations and performance studies conducted solely on the territory of the United Kingdom. This would have been a far more impactful option that would have done more to bridge the regulatory gulf between Great Britain and Northern Ireland.
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