What MHRA medical devices regulation consultation seeks to address

Posted: 08/12/2021

On 16 September 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) published its open consultation on the future regulation of medical devices in the United Kingdom (the consultation). Its objective is to update the Medical Devices Regulations 2002 (the regulation) that currently set out the regulatory framework for medical devices in the UK. Stakeholders are requested to provide responses by 25 November 2021.

Alongside the consultation, the MHRA announced its intention to address regulations applying to software and artificial intelligence (AI) as a medical device in the form of an extensive work programme. This will include reforms across the software as a medical device lifecycle, from qualification to classification, to requirements that apply pre- and post-market. The aim is to ensure the UK's framework adequately addresses the unique challenges and opportunities posed by advancing software and AI as a medical device.

The current regime

When the regulation first came into force in 2002, it implemented in the UK the EU's previous medical devices regime, which included three EU medical devices directives:

• Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the member states relating to active implantable medical devices;
• Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices; and
• Directive 93/42/EEC of 14 June 1993 concerning medical devices.

The EU's Medical Devices Regulation (Regulation (EU) 2017/745) (the EU MDR), which has been in force since 26 May 2021, repealed Directive 90/385/EEC on active implantable medical devices and Directive 93/42/EEC on medical devices following a four-year transition period. Directive 98/79/EC on in vitro diagnostic medical devices will also be repealed, by the In-Vitro Diagnostic Devices Regulation (Regulation (EU) 2017/746) (the IVDDR) due to come into force on 26 May 2022.

Neither of the two repealing EU regulations are retained by UK law following the UK's departure from the EU (other than in Northern Ireland where, due to the Northern Ireland Protocol, the EU MDR has applied from 26 May 2021 and the IVDDR will apply from 26 May 2022, in line with the EU’s implementation timeline).

Instead, the MHRA has plans for a new regime for regulating medical devices in the UK and the reforms contemplated by the MHRA are wide ranging. The consultation sets out the possible areas of reform, many of which will align the regulation with the new EU regime and international standards.

However, there are some areas of divergence from those other standards, such as new rules relating to the environmental sustainability and public health impact of medical devices. In addition, the MHRA is considering introducing some innovative routes to the UK market for manufacturers of medical devices. This includes a pathway for “innovative MedTech” aimed at devices developed for rare conditions that will be ‘game changers’ for end users and those manufactured by small- to medium-sized enterprises.

The consultation

The consultation aims to develop a new UK regime for medical devices that enables:  

• improved patient and public safety;
• greater transparency of regulatory decision making and medical device information;
• close alignment with international best practice; and
• more flexible, responsive and proportionate regulation of medical devices.

The consultation document itself sets out, over 15 chapters, the proposals on which it is seeking responses. These deal with the following issues:

1. The scope of the proposed regulation. The consultation proposes the expansion of the current definitions for medical devices and in vitro medical devices, including products without an intended medical purpose that have similar functioning and risk profiles to medical devices, such as cosmetic contact lenses and dermal fillers. Amendment to the scope of the regime would have the effect of more closely aligning the UK regime with internationally recognised definitions and reducing the impact of trade barriers between nations.
2. Classification. Changes to the classification of medical devices according to levels or risk are suggested to again align more closely with international best practice (including the new EU regime), but also to recognise changes in technology that better account for how medical devices are used. For example, one proposal, which reflects the new EU regime, is to classify active implantable devices and their accessories as Class III. Almost all software as a medical device (SaMD) is classified in Class II or above.
3. Economic operators. The objective of this chapter is to strengthen the accountability of manufacturers, importers and distributors engaged in the supply of medical devices. Suggested amendments include:

• requiring manufacturers to hold liability insurance to ensure adequate compensation of those adversely impacted by a medical device;
• the introduction of requirements for those selling medical devices at a distance via electronic means (e.g. websites and app stores);
• regulating claims made about medical devices to ensure they accurately reflect their safety, performance and intended purpose;
• setting out requirements for those importing or distributing medical devices to improve device traceability; and
• introducing a requirement to appoint a qualified person responsible for regulatory compliance.

4. Registration and unique device identifiers (UDIs). This chapter suggests amendments that relate to the traceability of medical devices and indicates a potential system of UDIs that the MHRA could use to trace devices, and that patients and professionals could use to report incidents.
5. Approved bodies. These are designated by the MHRA to assess whether manufacturers and their medical devices meet regulatory requirements. This part of the consultation indicates that the MHRA would like to set out more detailed requirements for approved bodies with the effect of raising the standard of best practice and increasing their transparency and that of their subsidiaries.
6. Conformity assessment. The intention of the MHRA is that assessments of medical devices (conformity assessments) are conducted with greater transparency and consistency. Amendments to the current regime, such as the introduction of additional scrutiny in assessments and expanding the required content of conformity assessment certificates, are proposed to tackle ever more complex software medical devices and implantable devices on the market, and to ensure that the safety of such devices is consistently and robustly assessed.
7. Clinical investigation/Performance studies. Manufacturers should collect and assess clinical data relevant to their medical devices to ensure their safety and performance. The consultation's suggested amendments to the current regime aim to produce consistent, comprehensive and systematic methods of investigation that protect the health and welfare of any participants of such assessment studies. Amendments include tightening requirements for claiming equivalence to another medical device, requiring documented evidence of scientific validity and analytical and clinical performance data for in vitro devices, and ensuring that those conducting clinical investigations or performance studies effectively obtain informed consent from study participants.
8. Post-market surveillance, vigilance and market surveillance. The consultation indicates that manufacturers of medical devices should continue to monitor medical devices once they are put on the market (post-market surveillance). The consultant requests responses on the possibility of a post-market surveillance regime, which concerns how information is collected and assessed and ensures that manufacturers report any safety incidents to the MHRA.
9. In vitro diagnostic medical devices. The consultation intends to update the in vitro medical devices regime to improve patient safety by increasing the level of scrutiny applied to such devices and making the provision of information relating to tests more transparent.
10. SaMD. The use of SaMD, which includes AI, is on the rise. The MHRA wishes to address this rise, and the increasing complexity of such devices. The MHRA suggests that technology has moved on to such an extent that the original regulation, when drafted, could not have envisioned the uses of such software medical devices. The proposals include drafting a clear definition of SaMD, the introduction of requirements for selling such devices, and introducing minimum requirements relating to cybersecurity. As mentioned above, the MHRA has published a new work programme to update the regulatory framework for software and AI as a medical device. The programme includes work packages across two workstreams: to make key reforms across the SaMD lifecycle and to consider the challenges posed by the advances in AI to medical device regulation. This includes proposals considering the qualification and classification of SaMD, as well as specific sections for cyber secure medical devices and mobile health and apps.
11. Implantable devices. The MHRA has identified the specific risks posed by implantable devices, due to the their uniquely invasive nature and how they are used. The consultation proposes expanding the scope of the regulation to include temporarily implantable devices, increasing the classification of certain implantable devices based on their potential risks, and introducing reporting and information provision requirements pre- and post-market.
12. Other product-specific changes. This chapter proposes product-specific changes, such as those that govern single-use or custom-made medical devices.
13. Environmental sustainability and public health impacts. The MHRA intends to use the consultation as an opportunity to update the environmental and sustainability objectives associated with the manufacture, use and disposal of medical devices in line with international commitments. The proposals include the introduction of environmental and public health impact assessments as part of conformity assessment and, the introduction of waste management responsibilities into supply chan.
14. Routes to market. To increase the appeal of the UK market, the MHRA is considering introducing some innovative routes to the UK market that can be utilised by manufacturers with a medical device single audit programme certificate, or with an approval from certain other international regulators. This will enhance the supply of devices to the UK market and emphasises the MHRA's support for the global harmonisation of medical device regulation. The MHRA is also considering other alternative pathways, in particular for “innovative MedTech” devices that meet certain eligibility criteria, such as devices used to treat rare conditions, devices that are “game changers” for end users or devices being manufactured by SMEs.
15. Transitional arrangements. The final chapter requests stakeholders' input into transitional arrangements that could be implemented to ensure the efficient and smooth transition to the new regime.

The above summary is not an exhaustive list of the topics on which the MHRA seeks responses, and some chapters are more extensive than others. The MHRA requests stakeholder input in each of the above chapters, but stakeholders are not required to provide responses to all the sections set out by the consultation.

It is the MHRA's intention that the new regime established following this consultation would come into force from July 2023. This would coincide with the date on which UKCA marking will become mandatory in the UK and the CE (EU) mark will no longer be valid. As indicated by chapter 15, the MHRA is keen to ensure that eventual introduction of the new regime is accompanied by adequate transitional measures to ensure a smooth transition to the new requirements, so responses to this chapter will likely be particularly critical to this goal.

This article has been co-written with Tom Perkins, trainee solicitor in the IP, IT and commercial team.

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