Following its public consultation on the future regulation of medical devices, the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulator, has announced its plans to improve patient safety and encourage innovation.
The medical devices landscape has shifted enormously over the last two decades since the Medical Devices Regulations 2002 were enacted in the UK. Those regulations implemented EU Directives that dated back to the 1990s and have now been replaced across the EU. The current UK framework didn’t envisage the number, range and complexity of devices used nowadays in the healthcare sector which have transformed medicine. The nature of individuals’ engagement with their own health has also been altered irrevocably by a myriad of factors ranging from COVID-19 to the the availability and ease of use of software devices.
The next step will be for the MHRA to prepare regulations setting out the detail of how this transformed regulatory framework will operate. For now, we know more about the content and, crucially, the timing for these changes.
In this briefing, we take a look at some of the key initiatives to be adopted. The full government response can be found at - https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom.
What are the goals behind the new measures?
The MHRA intends to build on the current strong regulatory foundation, its world leading reputation, international partnerships and globally recognised successes during the pandemic. With this platform, the government wants to realise the twin aims of protecting patients and the public as well as facilitating access for UK patients to the latest advances the MedTech sector can offer.
Health inequalities will be addressed and biases mitigated throughout the lifecycle of products. Internationally recognised standards will be set with the aim that the new UKCA mark is seen as a global exemplar. The scope and scale of this opportunity at reform are ambitious, with the ultimate prize being improving people’s health and future-proofing the regulatory safeguards as further innovation occurs.
What's on the canvas of reform?
The report runs to over 150 pages setting out the many different measures that will appear in the legislation. In terms of headlines:
- some products will be reclassified including certain implantable devices;
- the scope of regulations will be extended to capture certain non-medical products with similar risk profiles to medical devices, such as dermal fillers and coloured contact lenses;
- post-market surveillance requirements will be strengthened and increased, ensuring better incident monitoring, reporting and surveillance;
- improved traceability of medical devices, including the use of Unique Device Identification (UDI), will be introduced;
- regulation of novel and growing areas such as software, including artificial intelligence (AI) as a medical device, will be improved in order to offer alternative and safe routes to market for game changing innovation;
- routes to market which avoid duplication and minimise burden on industry will be introduced, including a pre-approvals route for innovative devices, with the MHRA broadening its role to host a conformity assessment function internally for certain products;
- the measures will ensure the UK aligns with international best practice where those standards are superior than current standards and greater transparency of regulatory decision making will be introduced through updating the requirements that apply to Approved Bodies and increasing the consistency of conformity assessments.
When will the reforms impact on the sector?
Of key concern for all in the industry has been their ability to comply with any timetable for change. The new EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Device Regulation (2017/746), despite being delayed by the pandemic, have already placed considerable burdens on manufacturers with concerns over Notified Body capacity, the ability to bring products to the market and meet the new requirements in time.
The MHRA has recognised that a “considered implementation plan for such an ambitious programme of reform is critical to its success”. Accordingly, the plans balance prioritisation and pace with the need to ensure there is time for the sector to adapt and that, vitally, patients and the healthcare system can continue to access the essential medical devices they need.
While the government still plans for the new regulations to come into force in 2023, there are significant measures for a phased introduction of the new requirements enabling products which already have conformity markings, either UKCA or CE, to remain on the market for a period of 3 to 5 years after the regulations come into force, depending on the device and the rules under which the existing conformity mark was given.
Although transitional arrangements will apply to the new requirements, the MHRA have stated two caveats. First, devices that are subject to significant changes in design or intended purpose will be excluded from these provisions. Secondly, all post-market requirements applicable to the new regulatory framework will need to be complied with for all products which benefit from the transitionary arrangements.
The fact that the new measures will be gradually phased in and that the industry will have time to adapt to the changes will be welcomed. Having said that, the EU has still issued a notice urging manufacturers to ensure compliance with the new EU Regulations well before the expiry of the transitional periods and not to view them as grace periods. Those putting medical devices on the UK market would be advised to do the same and continue with their planning for implementation.
Selected Highlights
The government response covers every aspect of the medical device sector. Some points to note include the following:
- Essential Requirements - it is the government’s intention to amend the essential requirements for medical devices, accommodating technological progress and aligning with other regulators in delivering international best practice where it is in the interests of the UK. The General Safety and Performance Requirements will be broadly reflected in the UK regulations, tailored to the domestic context.
- Manufacturer obligations: measures for recompense - manufacturers will have to have measures in place, such as sufficient financial coverage, for providing recompense to those impacted by adverse incidents with medical devices on the UK market. The intention here is that requirements will be commensurate with the type of device, risk class and size of company. It is not intended to establish a centralised compensation fund.
- Health Institutions - the intention is to include a definition of ‘health institution’ within the regulations and to provide further detail in supplementary guidance. Health institutions will be required to meet many of the regulatory requirements that apply to commercial manufacturers. The key differences will be an exemption for health institutions from UKCA marking requirements; an exemption from the requirement for Approved Bodies to be involved in the conformity assessment process; and an exemption from the requirement to have a certified Quality Management System (QMS), though a QMS will still be required. ‘In house’ manufactured or modified devices will have to meet the relevant essential requirements of the UK medical devices regulations but an exemption from UKCA marking requirements would be intended to reduce the burden.
- UK Responsible Persons (UKRP) – there will be an explicit requirement for the UKRP to have an address in the UK at which they are physically located. The government intends to introduce a requirement for UKRPs to have a Qualified Person permanently and continuously at their disposal, subject to the outcome of further consideration on how this would operate in practice.
- Traceability and UDIs - The MHRA wants to see greater transparency in its regulation of medical devices and more traceability across the UK. They propose to enhance transparency of information about medical devices by increasing the amount of information captured and shared about devices at the point of device registration. They also plan to introduce requirements that will help identify medical devices placed on the UK market, helping to address issues with devices where they arise. The government intends to bring in requirements for distributors and importers to cooperate with manufacturers, UKRPs, and public and private sector healthcare professionals and institutions, to achieve an appropriate level of traceability for medical devices.
- Clinical Evaluations - more detailed requirements will be necessary for conducting and documenting a clinical evaluation. The objective would be to ensure that medical device manufacturers conduct effective, consistent and systematic clinical evaluations of their medical devices, taking into account all relevant clinical data, in order to demonstrate that a medical device is safe and performs as intended. This would help ensure that medical devices are not placed on the UK market unless there is sufficient evidence of their safety and performance.
- Post-market Surveillance – the requirement for manufacturers to implement a post-market surveillance system will be clarified and strengthened. The UK medical devices regulations will be amended to require manufacturers to issue field safety notices (FSNs). Minimum requirements for the content of the FSN will be included.
- Software as a Medical Device (‘SaMD’) - the majority of change in this area is likely to be in the form of guidance rather than legislation, with the proposals aiming to ensure that the regulation of SaMD is ‘clear, effective, and proportionate to the risks’ these medical devices present. It is planned to add “A set of instructions that processes input data and creates output data” to the definition of ‘Software’ in the UK medical devices regulations. Feedback received called for clearer definitions including of ‘diagnose / treat’; ‘driving patient management’; ‘informing clinical management’; and ‘prediction’ / ‘prognosis’ and it will be interesting to see if the regulations provide such clarification. There is a proposal to amend the classification of UK medical devices to include the International Medical Device Regulators Forum’s SaMD classification rule for general medical devices. The intention is to proceed with the introduction of further essential requirements to ensure the safety and performance of SaMD. For post-market requirements, ‘predetermined change control plans’ (PCCPs) will be introduced on a voluntary basis but may be mandated in the future.
- Artificial Intelligence as a medical device (AIaMD) – The government currently does not propose to define AIaMD or set specific legal requirements beyond those being considered for SaMD.
Next Steps
Whether the UK has succeeded in its aims of improving patient safety while creating a landscape that fosters innovation and future-proofs its regulatory foundations will be a test of time but the proposals are largely in line with what was expected from the terms of the consultation.
The government has set a broad agenda but has kept in mind the need to stay aligned to EU and internationally recognised standards and allow sufficient time to phase in the new measures. All those working in the sector should take stock of impending changes as even the more realistic timescale for implementation will still require considerable work.
The detail will come in the legislation but at least there is now some certainty over content, timing and priorities. The MHRA is set to continue working and engaging with industry and stakeholders while refining the legislation and implementing the changes.
Please contact us if you wish to discuss the government response further.
