On 16 September, the MHRA published its long awaited consultation on the regulatory framework that will govern medical devices in the UK. This follows the publication in July of the MHRA Delivery Plan for 2021-2023, which made clear that the MHRA intends to “establish a new medical devices legislative framework for the UK to support safe innovation and ongoing access to products”.
The current framework for medical devices in the UK is set in the Medical Devices Regulation 2002, which implemented the EU Medical Devices Directives. However, the EU regime has now been substantially updated by the Medical Devices Regulations. Whilst the new Medical Device Regulations 2017/745 have been applicable in the EU since 26 May 2021, they do not apply in Great Britain and have not been implemented into UK law. The Regulations will, however, apply in Northern Ireland under the terms of the Northern Ireland Protocol. Similarly, the In Vitro Diagnostic Medical Devices Regulations 2017/746, due to apply in the EU from 26 May 2022, will not apply in Great Britain, but will apply in Norther Ireland.
The MHRA was heavily involved in the development of the new EU legislation and believed in the need to update the current Medical Device Directives and the UK Regulations. There have been concerns that as the updates to the EU regime do not apply in Great Britain, the UK may be seen as a less attractive country in which to develop and market medical devices, or that it does not protect patients to the same extent.
As such, the consultation focuses on patient safety and innovation (which are not mutually exclusive) whilst recognising that gaining and maintaining competitiveness in a global market will best be supported by alignment with internationally recognised best practice and standards, including greater alignment with the new EU Regulations.
The proposed new framework
The proposals have been set out over 15 chapters. We set out below a summary of the proposals, but this is by no means a comprehensive overview, and the impact of the proposed amendments are likely to be different for each stakeholder. The importance of patient safety is, however, a key consideration throughout.
Chapter 1 – Scope of the Regulations
This Chapter sets out proposals for amending the current legal definition of medical devices, to broaden the scope and encompass medical devices and IVDs as set out in the Global Harmonization Task Force’s (and/or its successor organisation, International Medical Device Regulators Forum (IMDRF)) internationally recognised definitions, and to take account of advances in medicine, engineering and technology. This would lead to some products not currently regulated in the UK falling into the new regime, and to some products no longer being considered as a medical device or IVD. Examples given of products that could fall under the proposed new approach are “products without an intended medical purpose that have similar functioning and risk profiles to medical devices” (such as cosmetic contact lenses) and “products which support conception”. It is also proposed to expand the definition of IVD to include software.
Chapter 2 – Classification of Medical Devices
General medical devices currently fall within one of four classes and the consultation considers whether these should be updated to align with international best practice. For instance, under the new EU Regulations, some devices have been “up-classified” and some are now required to undergo classification for the first time. The MHRA considers that similar amendment to the UK rules should be made to take better account of the significant technical progress made since the classification rules were established and of how medical devices are used, including a device’s level of invasiveness and potential toxicity, where appropriate. For example, a possible change could be for active implantable medical devices and their accessories to be classified as Class III, as opposed to Class IIb; this approach aligns with the new EU regime. The consultation recognises that this would require substantial amendment to the existing classification rules and definitions.
Chapter 3 – Economic Operators
The consultation asks whether the accountability of manufacturers, importers and distributors should be strengthened to help ensure devices are safe and meet their intended purpose. Whilst economic operators are defined under the new EU Regulations, and each have their own prescribed responsibilities, the same approach is not taken under the current UK regime. Accordingly, it is proposed that those involved in the supply of a device, such as a distributor and importer, should be defined to ensure clarity and that their responsibilities should be outlined in more detail, including giving further responsibility to the UK Person Responsible. Several other proposals for change are made in this section, including (but not limited to):
- requiring manufactures to hold liability insurance to cover legal liability arising from adverse incidents;
- bringing ‘in-house’ production of medical devices by health institutions within the scope of the regulatory regime, whilst still exempting such supply from certain requirements; and
- introducing regulations governing claims made by manufacturers about their medical device(s) to prevent misleading or unsubstantiated claims.
Chapter 4 – Registration and UDI
The consultation suggests the introduction of a system of Unique Device Identifiers used to trace devices and by which incidents could be reported. This aligns with the approach taken in both the US and the EU. A single UK database is proposed, to bring together information about medical devices on the market.
Chapter 5 – Approved Bodies
Approved Bodies have been designated by the MHRA to assess whether the requirements under the current UK Regulations have been met by manufacturers and their devices. The MHRA is seeking views on how to improve functioning of these bodies, including requiring them to have UK Accreditation Service (UKAS) accreditation.
Chapter 6 – Conformity Assessments
The consultation recognises that bringing additional products within the scope of the UK regime (as proposed in Chapter 1) or changing the classification criteria (as proposed in Chapter 2), may increase the number of devices requiring conformity assessment and/or change the required assessment for a device. As more innovative and (in many cases) complex devices are developed, the MHRA’s aim is to ensure conformity assessments are robust and effective at assessing device safety, quality and performance. The MHRA is also considering whether Approved Bodies should be able to impose restrictions on devices to certain groups of patients or to require specific post-market follow-ups.
Chapter 7 – Clinical Investigation and Performance Studies
This is the longest of the Chapters and contains extensive possible changes. It suggests that more detailed requirements on how clinical evaluations are conducted and documented could be introduced, including additional detail on content and scope, to ensure there is sufficient evidence on safety and performance. For example, stricter rules for claiming equivalence could be implemented and clinical investigation requirements for products without an intended medical purposes may be introduced. It also suggests enhancing the performance evaluation requirements of IVDs.
Chapter 8 – Post-Market Surveillance and Vigilance
The MHRA suggests that these requirements could be made clearer and more stringent to strengthen the level of surveillance undertaken by manufacturers, including reporting post-market findings to the MHRA. This change could be based on the manufacturer’s post-market surveillance plan to include details on, for example, serious incident data and field safety corrective actions (FSCA). The consultation proposes that similar requirements relating to post-market clinical follow-up could be introduced for IVDs. It suggests that the reporting of serious incidences and FSCAs should be a legal requirement, rather than being based on guidance, with new reporting criteria and timescales.
Chapter 9 – In Vitro Diagnostic Medical Devices
The MHRA proposes amendment to the IVD classification rules to increase the level of scrutiny IVDs are subjected to, in recognition of fast-moving developments in the industry, and to align the UK’s approach with international standards. Specific definition and clinical evidence requirements have been proposed for companion diagnostics. On genetic testing, to which particular rules under the current UK regime do not apply, the MHRA considers that amendments could be made to take into account the risk classification of such testing, whilst ensuring that users are provided with information of their nature, significance and implications.
Chapter 10 – Software as a Medical Device
This Chapter acknowledges that both software as a medical device (SaMD) and AI as a medical devices (AIaMD) have grown in market share and complexity and that the current framework has restricted their application within the healthcare system. The MHRA’s aim is to ensure the regulations are clear, effective and proportionate to the risks these devices present, and envisages that the majority of changes will be set out in guidance, rather than in legislation. For example, the MHRA has also announced a new work programme to provide a regulatory framework for software and AI. This programme includes eleven work packages, and the MHRA will release roadmaps for the work packages before the end of 2021.
The consultation proposes that the definition of software should be: “a set of instructions that processes input data and creates output data”. This definition is consistent with the definition in EU MEDDEV Guidance document on Qualification and Classification of stand alone software (MEDDEV 2.1/6). The proposed classification framework is stated to be aligned with the IMDRF guidance. The consultation also suggests modification of the definition of “placing on the market” to clarify that this includes deploying SaMDs on websites, app stores and via other electronic means. In relation to AIaMD, requirements on performance evaluation methods, similar to those used for IVDs, could be imposed.
Chapter 11 – Implantable Devices
The MHRA is considering expanding the scope of the regulations to include temporarily implanted devices and up-classifying certain implantable devices according to the level of risk associated with them, which may lead to more stringent pre-market requirements being introduced. The consultation suggests controlled access to high-risk implantable devices may be introduced, including supply of some devices only through practitioners with specialist expertise. Additional rules of post-market requirements may also be introduced, such as the supply of information about such devices to patients.
Chapter 12 – Other Product-Specific Changes (including on the re-manufacturing and re-processing of devices and custom made devices)
Chapter 13 – Environmental Sustainability and Public Health Impact
Chapter 14 – Routes to Market
The consultation states that the MHRA is considering introducing routes to the UK market for manufacturers with a Medical Device Single Audit Programme (MDSAP) certificate, or with an approval from another international regulator, whereby the manufacturer is subject to a domestic assurance process with an Approved Body. The MDSAP sets out a harmonised approach to auditing and monitoring the manufacturing of medical devices on an international scale. It allows medical device manufacturers to have a single audit of their Quality Management System which satisfies the requirements of multiple regulatory jurisdictions. The MHRA is also considering a different pathway for “Innovative MedTech”, such as devices developed by small to medium enterprises, for rare conditions or devices which are “game changers” for end users.
Chapter 15 – Transitional Arrangements
Timing for next steps
The MHRA has stated its aim to create and have in force a new regulatory regime by 1 July 2023 (although appropriate transitional provisions will be adopted). This will coincide with the requirement that all medical devices must be UKCA marked to be placed on the market in Great Britain; CE marks will cease to be accepted on the market in Great Britain at that time.
To meet this timeline, the current consultation is set to run for 10 weeks, until 25 November 2021. It contains a set of detailed questions throughout each Chapter, although there is no obligation for stakeholders to answer every question. The MHRA have also developed a short set of less technical, overarching questions which can be completed instead of, or in addition to, any questions in the technical set. We are aware that a number of industry associations are preparing responses to the consultation, and are also encouraging companies and stakeholders to reply individually.