(AGENPARL) - Roma, 25 Giugno 2022(AGENPARL) – LONDON sab 25 giugno 2022
Patient and public responses
Chapter 17 was written with the general public in mind or those with less time to spare.
If you would like to review the responses for the Chapter 17 questions only, see chapters: 1, 2, 3, 4, 7, 8, 11 and 14.
Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory framework for medical devices in the United Kingdom (UK).
The aim was to seek views on developing a future legislation for medical devices which delivers:
- 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 sought the views of patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public to help shape our future approach to regulating medical devices in the UK. It contained 15 technical chapters, one chapter on general feedback (Chapter 16) and one chapter on a range of topics aimed at lay persons and those with limited time (Chapter 17 – which we refer to in this document as the ‘abridged consultation’ chapter). The government response covers Chapter 17 of the consultation, and responses to it, within the main chapters where relevant (rather than having a dedicated chapter on responses to Chapter 17 as a whole).
The response
We received 891 consultation responses: 413 from individuals and 451 from organisations. Due to the large scale of the consultation, respondents were invited to select and respond to their areas of interest and most respondents therefore did not answer every question. The response rates to some questions do not add up to 100% because of rounding.
We encouraged responses from a wide range of people. Respondents were not required to provide their demographic data. Data from those who chose to provide it is as follows:
- 263 healthcare professionals
- 200 manufacturers of medical devices
- 84 members of the public / patients
- 56 healthcare institutions
- 24 trade associations
- 63 small/medium enterprises (small)
- 55 small/medium enterprises (medium)
- 54 small/medium enterprises (micro)
Highlights of the government response
In this far-reaching public consultation, the MHRA has received strong support for proposals that will enable the MHRA to improve patient safety and safeguard public health by enabling access to a high-quality supply of safe and effective medical devices through appropriate regulatory oversight. The MHRA will therefore proceed with preparing regulations reclassifying products such as certain implantable devices, extending the scope of regulations to capture certain non-medical products with similar risk profiles to medical devices (e.g., dermal fillers, coloured contact lenses) and to strengthen and increase post-market surveillance requirements ensure better incident monitoring reporting and surveillance.
Strong support was also heard for improved traceability of medical devices, including the use of Unique Device Identification (UDI).
The consultation also outlined changes with potential to improve support for innovation in medical devices, and access to medical devices. These included improving regulation of novel and growing areas such as software (including artificial intelligence (AI)) as a medical device to offer alternative and safe routes to market for game changing innovation.
The MHRA received strong support to introduce routes to market which avoid duplication and minimise burden on industry, promoting international collaboration with like-minded regulators while maintaining regulatory oversight. Responses showed significant support for the introduction of a pre-approvals route for innovative devices but also support for the Agency broadening its role to host a conformity assessment function internally for certain scenarios and product groups.
In November 2021, the Secretary of State for Health and Social Care announced the Equity in Medical Devices Independent Review, chaired by Dame Margaret Whitehead, which seeks to establish the extent and impact of potential ethnic and other biases in the design and use of medical devices. The MHRA recognises the role of regulatory standards for equitable outcomes and will provide extended guidance on how manufacturers of medical devices, including software and AI medical devices, can demonstrate and ensure the safety and efficacy of their products across diverse populations.
The government will also be introducing alternative routes to market, including domestic assurance, to enhance the supply of devices while retaining appropriate levels of scrutiny to ensure patient safety remains a priority. The changes the MHRA will be taking forward will also ensure the UK aligns with international best practice where those standards are superior than current standards and they will introduce greater transparency of regulatory decision making through updating the requirements that apply to Approved Bodies and increasing the consistency of conformity assessments for example.
Respondents recognised the scale of what was proposed and expressed support for a stepwise transition to the new framework, enabling smooth implementation for patients, the healthcare sector and industry. In Chapter 15 of this response, we set out transitional arrangements which respond to this feedback. Whilst we still plan for the new regulations to come into force in 2023, there are significant measures enabling products which already have conformity markings, either UKCA or CE, to remain on the market after the regulations come into force for a period of 3 to 5 years, depending on the device and the rules under which the existing conformity mark was given.
Outside the scope of this consultation, the MHRA has also announced a work programme for the regulation (wider guidance, policy, and standards) of health-related software and AI that will deliver ambitious change, providing protection for patients and public and making the UK the home of responsible innovation in this sector.
This document sets out what the MHRA has heard, the government’s response to the consultation, and the MHRA’s next steps for the implementation of a transformed regulatory framework for medical devices in the UK.
Fonte/Source: https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom
