The UK medical devices regime and the impact of the Northern Ireland Protocol
Published on 22nd Jul 2022
Life Sciences analysis: Peter Rudd-Clarke, partner, and Anna Lundy, associate director, at Osborne Clarke discuss how the medical device industry is impacted by the Northern Ireland Protocol.
This analysis was first published on Lexis®PSL on 11/07/2022 and can be found here (subscription required).
Divergence between Great Britain and the EU
In the EU, the Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)), altogether the EU Regulations, provide the framework for placing medical devices and in vitro medical devices (IVDs) on the market.
The EU Regulations have modernised medical devices legislation and have addressed flaws associated with the old system under Directive 93/42/EEC, Directive 90/385/ECC and Directive 98/79/EC (the EU Directives).
In Great Britain, medical devices and IVDs are regulated under the Medical Devices Regulations 2002 (the 2002 Regulations), SI 2002/618, which implemented the EU Directives. As set out below, the EU Regulations apply in Northern Ireland.
The EU Regulations did not take effect during the Brexit transition period and, as a result, they did not automatically pass into UK law as retained EU law under the European Union (Withdrawal) Act 2018.
Key requirements for the GB market
Requirements for placing medical devices on the GB market in part depend on the manufacturer's location. If outside the UK, manufacturers must appoint a UK Responsible Person (UKRP) who assumes regulatory responsibility for the device.
Devices need to undergo a conformity assessment by a UK based approved body (if they are not subject to self-assessment only such as Class 1 devices) and, from 1 July 2023, the new UKCA mark will need to be affixed to the medical device. Until then, the CE mark will be accepted in GB. Devices may need to be registered with the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
The framework concerning medical devices in Northern Ireland is subject to the Northern Ireland Protocol (the NI Protocol) and specifically the Medical Devices (Northern Ireland Protocol) regulations 2021, SI 2021/905, which provides for the implementation of the MDR. The IVDR applies in Northern Ireland too. Medical devices moving from or through GB to NI are considered an import into the EU and are subject to the EU Regulations. The objective of this is to avoid the need for a customs border between NI and the Republic of Ireland. Practically, this enables free movement of goods between Northern Ireland and the rest of the EU.
Key differences with the GB regime
As NI follows the EU Regulations, manufacturers supplying into NI from GB will need to appoint an Authorised Representative. The MDR also expanded what constitutes a medical device, for example, fashion contact lenses. Additionally, many medical devices moved up a Class in the MDR and now require notified body assessment, unlike in GB. The UKCA mark will not be valid in NI, where the CE mark is instead required. Where distributors are importers, they have importer responsibility. This includes supermarkets.
Issues faced by the UK medical devices industry
Medical device manufacturers are already struggling with significant delays in getting devices certified and re-certified by notified bodies under the MDR. The UK medical devices industry now faces the additional challenge of complying with two separate regimes to access both its own internal market (GB and NI) and the EU.
Additionally, because medical devices entering NI from the rest of GB are classed as imports, there are further checks on them at NI entry points. This has increased costs due to the time and resources needed to complete paperwork.
Areas of potential divergence
The UK government recognised that the law needed to be brought up to date for the GB market and so launched a consultation in 2021, via the MHRA into the future regulation of medical devices. The UK government published the results of the consultation, and its response, on 26 June 2022.
The UK government has stated that it will use the Medicines and Medical Devices Act 2021 to enact secondary legislation to reform the regime applicable to GB. Although the UK government has not yet published draft legislation, the response published on 26 June 2022 indicates where the UK government intends to mirror the EU Regulations but also where it wants the GB market to diverge from the EU model.
In critical areas like expanding the scope of regulations, classification of some devices as higher risk, and obligations concerning traceability, the UK government has indicated that the GB regime will align with the EU's.
However, the UK government plans for the GB market to diverge from the EU system in specific areas. The Independent Medicines and Medical Devices Safety Review of 2020 criticised the lack of patient and public involvement in monitoring the safety of medical products. This appears to have led to the aim of involving patients and the public in post-market surveillance requirements. In addition, the UK government wants to make it more difficult for manufacturers to claim that a new medical device is compliant on the basis it has 'equivalence' status to an existing product (further tightening requirements intended to make products safer). The political drive to look beyond the EU market can be seen in the proposals to recognise certifications granted by other countries.
Impact of the Northern Ireland Protocol Bill
The Northern Ireland Protocol Bill seeks to, inter alia, disapply certain parts of the current NI Protocol and Withdrawal Agreement, remove jurisdiction of the Court of Justice of the EU and bring NI under the UK's subsidy control regime.
For manufacturers, the critical element of the Bill is the government's intention to allow businesses to choose between placing goods on the NI under either UK or EU rules, even if UK and EU regulations diverge over time. For goods moving from GB to NI and staying there, regulatory checks and controls would not be required. These checks and controls would, however, still be required for goods intended for the Republic of Ireland and the rest of the EU.
The government plans to implement this through expanding the trusted trader scheme, financial penalties for non-compliance and data-sharing. This flexibility could make the NI market attractive to businesses based in both GB and the EU and would be a significant change from the status quo which requires goods placed on the NI market to be compliant with EU rules only. However, time will tell whether these provisions are amended by Parliament, assuming the Bill itself survives political pressures.
Getting ready for the new UKCA regime
The UK government intends the new UKCA regime, replacing CE marking, to come into force on 1 July 2023. However, in its response to the MHRA's consultation, the UK government has stated that industry will be able to take advantage of transitional arrangements under which products that already have UKCA or CE certification will be able to remain on the market after the new regulations come into force. General medical devices can be placed on the market until either the certificate expires or for three years after the new regulations take effect (in the case of IVDs, five years), whichever is sooner.
Caveats to this are that transitional arrangements will not apply to a product where there have been significant changes in its design or intended purpose. In addition, all post-market requirements under the new framework will need to be complied with, even if transitional provisions are applicable.
Notwithstanding the transition periods, the UK medical devices industry can start to prepare for the new regime by considering whether products which are not currently regulated as medical devices will in future be regulated as such (for example, cosmetic contact lenses or dermal fillers). Businesses should also prepare for the GB market to broadly fall in line with the EU regime when it comes to classification of products, requirements on importers and distributors and traceability. However, the devil of compliance is in the detail and companies will need to consider the draft legislation when the government publishes it, as well as expected guidance from the MHRA, on how companies can take practical steps to ensure that they are compliant.
Companies placing medical devices on both the GB and NI market will need to keep one eye on the UK government's plans for reform, and another on developments concerning the NI Protocol.