Apr. 24 2009
Source Page: Medicines and Health Care Products Regulatory Agency (MHRA) business plan for 2009-10. 34 p.Found: Medicines and Health Care Products Regulatory Agency (MHRA) business plan for 2009-10. 34 p.
May. 21 2024
Source Page: MHRA announces consultation on improved safety for high risk in vitro diagnostic devicesFound: MHRA announces consultation on improved safety for high risk in vitro diagnostic devices
Mar. 11 2024
Source Page: MHRA response to Equity in Medical Devices: Independent ReviewFound: MHRA response to Equity in Medical Devices: Independent Review
Mar. 08 2024
Source Page: Voluntary scheme aggregate net sales and payment information: February 2024Found: Voluntary scheme aggregate net sales and payment information: February 2024
May. 07 2024
Source Page: Update on pioneering initiative on regulation and evaluation of digital mental health technologiesFound: Update on pioneering initiative on regulation and evaluation of digital mental health technologies
Asked by: Chi Onwurah (Labour - Newcastle upon Tyne Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to improve the regulatory environment for medical devices and technology.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is progressing reforms to the Medical Devices Regulations 2002. These are outlined in the Government response to the consultation on the future regulation of medical devices in the United Kingdom published in June 2022.
On 9 January, the MHRA published a roadmap, which sets out a clear path for the development of new and robust regulations for medical devices over 2024 and 2025. The new regulations will put patient safety first, whilst enhancing the United Kingdom’s position as a world-leading environment for medical technology innovators.
In September 2023, the Department, in partnership with the MHRA, the National Institute of Care Excellence, NHS England, Health Technology Wales and Scottish Health Technology Group, launched the Innovative Devices Access Pathway pilot. The pilot provides an accelerated pathway for innovative technologies that meet an unmet need in the National Health Service, including regulatory and support to streamline their adoption into the NHS.
Mar. 14 2024
Source Page: Freedom of Information responses from the MHRA - week commencing 6 November 2023Found: The MHRA codes medical devices within adverse incident reports using the Global Medical Device Nomenclature
Feb. 14 2024
Source Page: Funding for game-changing tech which could destroy cancers and predict diseaseFound: Funding for game-changing tech which could destroy cancers and predict disease
Feb. 14 2024
Source Page: Funding for game-changing tech which could destroy cancers and predict diseaseFound: Funding for game-changing tech which could destroy cancers and predict disease
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what progress they have made in aligning medical device regulations with those of international counterparts, and what impact this alignment is expected to have on patient safety, healthcare efficiency and innovation in the life sciences sector.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Following the Medicines and Healthcare products Regulatory Agency’s (MHRA) Consultation on the future regulation of medical devices in the United Kingdom, we have committed to undertaking full reform of the current regulatory regime for medical devices in the UK. The MHRA’s Roadmap towards the future regulatory framework for medical devices sets out a route to deliver, enabling regulation via a series of new statutory instruments (SIs). Priority measures to protect patient safety will be put in place this year, with core elements of the new framework intended to be in place by 2025. A draft statutory instrument to introduce strengthened post market surveillance requirements is planned to be laid in the first part of 2024. A copy of the roadmap is attached.
Following the announcement on the Chancellor’s Life Sciences Growth package in May 2023, we continue to progress the development of a framework for international recognition, including through targeted engagement with stakeholders, building on the outline proposals for alternative routes to market which were included in our 2021 consultation. The planned regulations are also designed to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances.
Implementing the remainder of the changes outlined in the June 2022 Government response to the 2021 consultation is ongoing. In September 2023, we launched the Innovative Devices Access Pathway as pilot, building the UK offer to innovators of medical devices addressing un-met clinical needs. In the coming year, we also plan to lay further SIs, bringing clarity to industry of the requirements they will need to meet to launch products in the UK in the future. Whilst these changes were outlined in the 2022 government response, we will ramp up our targeted engagement to ensure implementation is done smoothly and in a way that protects ongoing safe supply of products to UK patients.