AXREM summary of the MHRA response to the consultation on the future regulation of medical devices in the UK

06 July 2022

MHRA published their response to the consultation on 26 June. AXREM have reviewed this document and summarised the key messages below for our members.

Please note we recommend you review the document in full to determine which aspects are relevant to your company. There may be some changes in classification (SaMD for example) but generally in line with EU MDR regulation.

Essential requirements for medical devices, UK to align with other international regulations to accommodate new technologies.

Manufacturer obligations – measures for recompense

The government intends to introduce a requirement for manufacturers to have measures in place (for example, sufficient financial coverage) for providing recompense to those impacted by adverse incidents with medical devices on the UK market. This will be covered in the new regulation once published.

Health Institutions

Where Health institutions manufacture or Modify Medical Devices they will require a QMS system and technical documentation and be responsible for Adverse event reporting. In effect any modification will then deem the modifier of the device as a manufacturer.

UKRP is legally liable (responsible or answerable in law) for defective medical devices on the same basis as the manufacturer, subject to further consideration on how this would operate in practice

MHRA intend to introduce a requirement for UKRPs to retain technical documentation relating to such devices for the expected lifetime of a device after the product has last been manufactured or 10 years (whichever is longer).

The government intends to introduce a requirement for UKRPs to have a Qualified Person (similar to the EU PRRC ) permanently and continuously at their disposal, subject to the outcome of further consideration on how this would operate in practice. Regulatory affairs manager would need to either have a Regulatory Affairs qualification or 5 years experience.

Obligations of importers and distributors

The consultation set out a number of obligations on importers and distributors that could be introduced. After careful consideration of all responses, the government intends to proceed with the proposal to introduce obligations on importers and distributors, as outlined in the consultation. MHRA consider that this approach will improve device traceability, helping to ensure the safe supply of medical devices to the UK market. Additional guidance may be necessary to clarify the roles and responsibilities of importers and distributors, and the government intends to produce supplementary guidance on the regulatory requirement.

Cases in which obligations of manufacturers apply to other economic operators.

After careful consideration of responses, it is the government’s intention to proceed with the proposal to amend the UK medical devices regulations to clarify the circumstances in which an economic operator other than the device manufacturer would and would not be required to take on the responsibilities of the manufacturer.

Post market surveillance and vigilance reporting look as if they will be in line with the current EU MDR.

Software as a medical device

Background: Software as a medical device (SaMD) – being standalone software and software included in wider hardware and including artificial intelligence (AI) as a medical device (AIaMD) – has grown in market share, public health significance and complexity in recent years. It has applications in health and social care that could not have been envisioned when existing regulations around medical devices were developed, and it is anticipated that these applications will continue to increase in coming years. The MHRA wants to ensure the scrutiny applied to SaMD is more commensurate with their level of risk and therefore better protect public health, propose to adopt the risk categorisation in the IMDRF Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations for classifying SaMD that are general medical devices (not IVDs) with consequential implementing rules.

Transitional arrangements

The government intends to introduce the transitional arrangements general medical devices that hold a valid certification/declaration of conformity to the CE standard, issued under the EU Medical Devices Regulation. The government would like to establish a transitionary arrangement for these products which will allow products to continue to be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner. This will apply even if the certification/declaration of conformity is dated after the new regulations take effect. Products certified to this standard will be permitted to be placed on the Great Britain market for up to five years from the date on which the new regulatory framework takes effect, with a view to reviewing this provision at the end of the five-year period.