On 26 June 2022, the MHRA published the UK Government’s response to the consultation on the regulatory framework for medical devices in the UK (the Response), and following analysis of the nearly 900 responses received, its intentions for the future UK regulatory regime for medical devices (the UK Regulations).
In September 2021, we posted about the MHRA’s consultation, with a summary of the proposals set out across 15 technical chapters. The consultation ran between September and November 2021, and focused on patient safety and innovation, whilst recognising that gaining and maintaining competitiveness in a global market will be best supported by aligning with internationally recognised best practice and standards.
We have considered the Response and set out some of the key factors we consider to be of particular interest below. We have not precisely follow the order in the Response and have not covered every aspect or changes; this is necessarily a high level summary.
While the approach the MHRA intends to take in the UK Regulations is clarified and set out in more detail in the Response, no draft statutory text has yet been published. A lot of detail will also be left to guidance that will accompany the UK Regulations. It will therefore be important to see how closely aligned the new UK framework is to the proposals described in the Response and with international rules and standards.
The UK Regulations
The Response states that the UK Regulations will be built on five pillars:
- Strengthening MHRA power to act to keep patients safe;
- Making the UK a focus for innovation, and the best place to develop and introduce innovative medical devices;
- Addressing health inequalities and mitigating biases throughout medical device product lifecycles;
- Proportionate regulation which supports businesses through access routes that build on synergies with both EU and wider global standards; and
- Setting world leading standards, including building the UKCA mark as a global exemplar.
The aim remains to better align with international best practice where this is to the benefit of UK patients, and diverging only where advantageous to do so. On the whole, the proposals bring the UK regime into line with the requirements in the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), and refer to international definitions and guidance, such from the International Medical Device Regulators Forum (IMDRF).
The UK Regulations will apply in Great Britain (England, Wales and Scotland); under the terms of the Northern Ireland Protocol, the EU MDR and IVDR apply in Northern Ireland.
The MHRA intends to amend the definitions of medical devices and IVDs in line with international guidance (as set out in the consultation), and to extend the scope of the UK Regulations to include some non-medical products with a similar risk profile to medical devices, such as dermal fillers (which are expected to be Class III), tattoo and hair removal lasers, and coloured contact lenses. Registration of such products with the MHRA will be required. Health and wellness diagnostic tests will not be included at this stage.
The ‘intended purpose’ of all medical devices is to be construed objectively, and seemingly brought in line with the definition contained within the EU MDR. Furthermore, as with the EU legislation, the distinction currently made in the UK Regulations between active implantable medical devices and other medical devices will be removed.
The Response acknowledges that existing classification rules in the UK are, in some respects, out of step with best international practice, particularly for implantable medical devices such as surgical mesh and software as a medical device. The MHRA intends to progress the classification changes outlined in the consultation. Accordingly, there will be a reclassification – and likely up-classification – of certain products, including certain implantable devices, as has taken place in the EU. The MHRA intends to publish guidance on the changes to the classification rules alongside the legislation.
The IVD classification rules will be amended to increase the level of scrutiny applied to IVDs, using a series of rules that will align the UK more closely with the structure used by the IMDRF (which are also broadly in line with the approach to classification in the EU IVDR). This will support global harmonisation efforts and assist in providing a risk-based approach to classification of IVDs. However, the new IVD classification system will classify genetic tests proportionate to their risk, and will introduce risk-based classification rules specifically for companion diagnostics (rather than having all companion diagnostic products as a particular class as in the IVDR).
The MHRA intends to strengthen the accountability of manufacturers, importers and distributors engaged in the supply of medical devices, with the aim of driving up safety standards. Some key changes are as follows:
- Various obligations relating to the UK Responsible Persons (UKRP) will be laid down in the UK Regulations, including legal liability for defective medical devices on the same basis as the manufacturer;
- The manufacturer and UKRP should have access to a qualified person to support regulatory compliance, which seems to be a similar role to the Person Responsible for Regulatory Compliance in the MDR and IVDR.
- In line with the MDR and IVDR and current guidance, greater obligations will be placed on importers and distributors, to help improve traceability.
- In relation to fulfilment service providers (FSP), the UK Regulations will clarify that FSPs will fall within the scope of an economic operator and need to meet the requirements of ‘importers’ or ‘distributors’ depending on their role in the supply chain, taking in account the risk of duplicative labelling and registration requirements. This appears to be a departure from the MDR, under which the MCDG guidance notes that FSP may have this role in certain circumstances.
- Economic operators will be required to inform the MHRA if they are aware of any issues that will interrupt supply or cause a shortage of medical devices on the UK market.
Registration and UDI
The Response notes that there is strong support to make improvements in this area, including for the introduction of a globally harmonised device identification and coding system, which allows unambiguous identification of a specific device on the UK market. Under the UK Regulations, medical devices will require assignment of a Unique Device Identifier (UDI) before being placed on the UK market. Furthermore, a more comprehensive registration database for medical devices will be established, which will include UDI information. It is currently unclear to what extent this system will be aligned with the EU system of UDIs.
The intention is to bring in ‘essential requirements’ for medical devices in alignment with the EU MDR and EU IVDR, with tailoring to the domestic context. This includes closer alignment with the General Safety and Performance Requirements.
The aim remains to ensure conformity assessments are robust and effective at assessing device safety, quality and performance. Changes include removing the option to use batch verification (except for Class D IVDs) and type examination for all medical devices; subjecting Class IIB implantable devices to 100% review of technical documentation; and, prohibiting parallel conformity assessment applications to more than one Approved Body. The MHRA noted that batch verification, product quality assurance and type examinations are rarely used, therefore excluding these as possible assessment routes should not have a significant impact. Furthermore, the minimum content of Certificates of Conformity and Declarations of Conformity shall be detailed in the UK Regulations.
In relation to obtaining conformity assessment by demonstrating equivalence with a device that is already on the market, the MHRA intends to introduce requirements that the device a manufacturer is claiming equivalence to should be “entirely equivalent” to the manufacturer’s medical device (on a biological, physical, and clinical basis). This appear to take the UK beyond the equivalence requirements in the EU MDR. The Response states that it is hoped that the proposed approach will help mitigate the risks of “product creep”, where new devices on the market in practice become very different from their equivalent devices.
Alternative routes to market
The Response notes that there was strong support to introduce routes to market that avoid duplication and minimise burden on industry, promoting international collaboration with like-minded regulators while maintaining regulatory oversight. The MHRA intends to use both Medical Device Single Audit Program (MDSAP) certificates and Domestic Assurance as alternative routes to market in the UK, which will enhance the supply of devices while retaining appropriate levels of scrutiny to ensure patient safety remains a priority.
There was significant support for the introduction of a pre-approvals route for innovative devices but also support for the MHRA broadening its role to host a conformity assessment function for certain scenarios and product groups. The MHRA therefore intends to establish an innovative MedTech route to market, though this will be limited to specific, defined circumstances.
Clinical Investigation and Performance Studies
This is the longest section of the Response, detailing that a wide range of more stringent pre- and post-market requirements for medical devices will be introduced, including for clinical evaluations and performance studies, which are intended to drive up patient safety standards. Similarly, performance evaluation requirements of IVDs will be enhanced.
More detailed requirements on how clinical evaluations are conducted and documented will be introduced, including additional detail on content and scope, to ensure there is sufficient evidence on safety and performance. Non-UK based sponsors of clinical investigations and performance studies will be required to appoint a UK-based legal representative.
The MHRA also intends to proceed with the proposal to introduce clinical investigation requirements for products with similar functions and risk profiles to medical devices that do not have an intended medical purpose.
Post-market surveillance, vigilance and market surveillance
Requirements will be strengthened and increased, to ensure better incident monitoring and reporting, and increase responsiveness to any post-market issues. The UK Regulations will be amended to clarify and strengthen the requirement for manufacturers to implement a post-market surveillance system in respect of all medical devices they have placed on the UK market. Definitions of “serious incident”, “serious deterioration” and “serious public health threat” will be included in the UK Regulations.
Manufacturers will be required to report statistically significant data, including any statistically significant increase in the frequency or severity of incidents that could have a significant impact on the benefit-risk analysis. Furthermore, manufacturers will be required to issue field safety notices (FSN), with the minimum requirements for content being outlined in the UK Regulations.
The MHRA will also be required to notify the manufacturer or UKRP of any new risks it has identified in relation to a device through active monitoring of data.
Liability and compensation
Manufacturers will be required to have measures in place (such as sufficient financial coverage) to provide recompense to those affected by adverse incidents related to medical devices, with such requirements being proportionate to the type of device, risk class and size of company. Similar provisions were hotly debated during the legislative process of the MDR and IVDR, and we would expect the same with these provisions in the UK.
In-house manufactured product and laboratory developed tests
A definition of “health institution” will be incorporated into the UK Regulations. Health institutions will be required to meet many of the regulatory requirements that apply to commercial manufacturers, and will be subject to inspection by MHRA. However, there will be an exemptions for health institutions relating to UKCA marking requirements, involvement of Approved Bodies in conformity assessment, and the requirement for a certified QMS. This is to ensure that health institutes can continue to service patients with rare conditions.
‘In house’ manufactured or modified devices will need to meet the relevant essential requirements of the UK Regulations, in a similar way to commercially available devices. However, certain exemption will apply where the device is put directly into service and not placed on the market. Medical devices manufactured or modified in-house will be required to register with the MHRA.
The position in the Response appears to be that such test will not benefit from any transitional provisions, which will mean such test would have to comply with the requirements by July 2023. We would expect these provisions and the scope of any exemption to be the subject of substantial debate while the legislation is finalised.
Software as a medical device (SaMD)
A new definition of “software” will be included in the UK Regulations, currently proposed as follows: “A set of instructions that processes input data and creates output data”. The MHRA also acknowledges that there is interest in defining other associated terms.
The classification rules in the UK Regulations will be amended to include the IMDRF SaMD classification rules for general medical devices, but not IVDs, to allow for international alignment. This is likely to lead to up-classification of software, which was one of the areas that industry hoped the MHRA may offer more discretion compared to the EU MDR. Further essential requirements will be introduced to assure the safety and performance of SaMD specifically, including cybersecurity and data protection issues, similar to those in the MDR.
With regard to AI as a medical device (AIaMD), the MHRA does not propose to define AIaMD or set out specific legal requirements beyond those being considered for SaMD, as this would risk being overly prescriptive.
Other relevant changes
- The MHRA does not plan to introduce any changes to the scope of medical devices regulated as implantable medical devices at this time. While changes to classification rules will have implications for the level of scrutiny a device undergoes, as well as the intention to strengthen clinical evaluation requirements of all medical devices, it is not considered that further implantable-specific requirements are required in technical documentation and to clinical evidence requirements. Additional rules of post-market requirements will be introduced, such as the supply of information about such devices to patients and the use of implant cards.
- Additional requirements will be placed on UK Approved Bodies and the Response indicates that there was a strong preference for alignment with other jurisdictions. Approved Bodies will be required to hold appropriate UKAS accreditation. Further, the MHRA intends to allow Approved Bodies to conduct fully remote or hybrid audits of their clients in specific circumstances.
- The intention is to move regulatory requirements for the re-manufacturing of single-use devices into the legislation to ensure enforcement action is available. Furthermore, the re-manufacture of Class I single-use devices will be prohibited, as will the re-processing of single-use medical devices.
- The UK Regulations will be amended to include the term ‘kit’ and will introduce additional requirements for assemblers of systems, kits and procedural packs, taking in account the need for international alignment.
- Components that make a significant change to the safety and performance of a medical device will be regulated as medical devices in their own right.
- More detailed requirements relating to technical documentation and some stringent requirements for the post-market surveillance for custom-made devices will come into effect. Class III and IIb custom-made devices should require a certified QMS.
- The MHRA also noted that there is significant support for introducing requirements for claims made about medical devices to ensure that these accurately reflect the safety, performance and intended purpose of the medical device.
- The intention of the proposals is to drive better environmental outcomes that compliment or enhance patient safety.
- The Response refers to the establishment of the Equity in Medical Devices Independent Review, which seeks to establish the extent and impact of potential ethnic and other biases in the design and use of medical devices.
At the time of the consultation, the intention was for the new regulatory regime to be in force by 1 July 2023. This is still the plan, but there are significant measures enabling products that already have conformity assessment markings, either UKCA or CE, to remain on the UK market after the UK Regulations come into force:
- Products that are EU CE marked under the MDR or IVDR can continue to be placed on the UK market until either the certificate expires or for 5 years after the UK Regulations take effect, whichever is the sooner. This will apply even if the certification/ declaration of conformity is dated after the UK Regulations take effect.
- For medical devices that hold a EU CE mark issued under the MDD, AIMDD and IVDD before the new UK Regulations take effect, these can be placed on the market until the certificate expires or for an additional 3 years (for general medical devices), and 5 years (for IVDs) after the UK Regulations take effect, whichever is sooner.