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Published 5 julio 2022
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:
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.
The government response covers every aspect of the medical device sector. Some points to note include the following:
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.
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