“Government response to consultation on the future regulation of medical devices in the United Kingdom”
Medical device regulations update for NHS maxillofacial services
August 2022
Outline
On 26 June 2022, the HM Government published their response to the MHRA consultation: “The future regulation of medical devices within the UK”.
This document takes the form of 16 response sections, a number of which contain outcomes that will have an operational impact on all NHS maxillofacial laboratory services.
Following a three month consultation period, between September and November 2021, MHRA received a total of 891 responses: 413 were from individuals and 451 from organisations. Respondents (that provided relevant demographic data) were classified as;
| 263 | healthcare professionals |
| 200 | medical device manufacturers |
| 84 | members of the public/patients |
| 63 | small enterprises |
| 56 | healthcare institutions |
| 55 | medium enterprises |
| 54 | micro enterprises |
| 24 | trade associations |
With specific consideration for the goals and rationale of the consultation;
- 92% of respondents believed the ambition/scope of the consultation was good to excellent while 7% viewed this question as poor,
- 67% of respondents viewed the consultation as proportionate, 18% believed it to be disproportionate, and 15% had no opinion.
HM Government Response
This response clearly outlines the intention of HM Government to clarify and strengthen current legislation concerning the manufacture and supply of medical devices in the UK. Alongside UK economic operators, Healthcare Institutions will ultimately be required to comply with any new statute.
Key areas of note for NHS Maxillofacial Prosthetists/ Reconstructive Scientists are outlined in the points below.
- Issues associated with the ‘in-house’ manufacture of medical devices by Healthcare Institutions will be addressed to apply a more systematic approach to regulation and improve patient safety.
- There is the intention to identify and record the manufacturing activities of all UK Healthcare Institutions to improve the traceability of all medical devices.
- It is recognised that forthcoming legislative requirements, and any consequent liability measures for recompense, are a concern and will effect Healthcare Institutions.
- Any new statute will clearly define the term ‘Healthcare Institution’.
- While Healthcare Institutions will be required to meet many of the legal obligations that commercial operators must follow, key exemptions include the necessity to involve Approved Bodies with conformity assessment processes.
- Healthcare institutions will not require an Approved Body to certify a quality management system, but they must still maintain a QMS.
- It is recognised as disproportionate/unfeasible that all manufacturers of custom-made medical devices will require Approved Body certification for their QMS; i.e. such as for dental crowns & bridges. However, all manufacturers will require a QMS to cover (dental) Class I and Class IIa devices.
- It is acknowledged that Medical device prescriptions, detailing device design, characteristics, etc., can be provided electronically by a medical practitioner.
- Healthcare Institutions will be obliged to assign a UDI to, and register all medical devices manufactured, retain technical documentation, and record manufacturing details.
- Healthcare Institutions will be required to supply medical device details to MHRA as necessary; i.e. for audit or inspection.
- Healthcare Institutions will be obliged to provide stringent post-market surveillance measures to develop adverse incident reporting.
- MHRA will be able to inspect the manufacturing activities of all Healthcare Institutions and take enforcement action as necessary.
- Healthcare Institutions will be required to record and store UDI numbers for all implantable devices.
- Key, relevant information, regarding implantable devices, will be provided by Healthcare Institutions to patients, and logged into the patient record.
Comment
This is the most far reaching consultation to date regarding the manufacture and supply of medical devices within the United Kingdom. It is clear that HM Government intention is to supersede and elevate current international legislation, such as EU regulation 2017/745, to ensure the continued export of medical devices from UK economic operators.
In addition, following recent widespread public concern involving medical devices; mesh implants, breast implants, pacemakers, etc.; this consultation provides strong support for MHRA to improve their supervisory oversight. To this end, MHRA now have a clear mandate for the preparation of new legislation to transform the regulatory framework within the UK to improve public health safety.
References
- https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1085333/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_the_United_Kingdom.pdf
- https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
- https://www.impt.co.uk/2021/07/29/mhra-registration/
- IMPT website, News item: MDR Update, 01 July 2021
- IMPT website, News item: Medical Device Regulations, 08 October 2020
- https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/999071/MHRA_Delivery_Plan_21-23_Final_210618.pdf
- https://www.gov.uk/government/publications/the-medicines-and-healthcare-products-regulatory-agency-delivery-plan-2021-2023/medicines-and-healthcare-products-regulatory-agency-delivery-plan-2021-2023
- https://www.legislation.gov.uk/uksi/2002/618/regulation/15/made
- https://www.gov.uk/government/publications/custom-made-medical-devices
- https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#who-must-register
- https://www.gov.uk/government/publications/in-house-manufacture-of-medical-devices/in-house-manufacture-of-medical-devices
