The draft statutory instrument for post-market surveillance requirements under the new UKCA regime has been published on the World Trade Organisation website. The notification can be found here.
The draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 is applicable to Great Britain only. It introduces a new part, Part 4A, which defines the post-market surveillance requirements of medical devices, IVD devices and custom-made devices, excluding those intended for clinical investigation or performance evaluation. In summary, this SI includes:
- Requirement for a post-market surveillance system for all devices
- Requirement for a post-market surveillance plan for all devices
- Requirement for post-market surveillance reports for:
- Class A and B devices (conforming to the IVDR)
- Devices not included in Annex II list B or Annex II list A (conforming to the IVDD)
- Requirement for post-market surveillance update reports for medical devices and IVDs not listed as needing a post-market surveillance report (i.e. Class C and D under the IVDR, or devices in Annex II of the IVDD)
This SI includes new definitions relevant to post-market surveillance such as “Lifetime of a device”, “Lifespan of device” and “PMS period”.
To help improve the ability of both the manufacturer and the MHRA to identify issues with medical devices and to take appropriate action to safeguard public health, the SI mandates that every manufacturer must establish a post-market surveillance system proportionate to the device type, risk posed by the device and the quality, performance and safety data of the device.
Additionally, this SI details the requirements for collecting and analysing device-related information. It emphasises that the PMS plan must include information on user-experience, serious incidents, processes to collect and analyse user and patient feedback and complaints, and statistical methodology to manage incidents and trends. The SI further describes preventive and corrective actions, reporting of serious incidents, field safety corrective actions and field safety notices. Many of these are consistent with requirements under the IVDR, but with an additional emphasis on patient involvement, and utilisation of statistical methodology.
This SI outlines the requirements of post-market surveillance reports and periodic safety update reports. Manufacturers of medical devices belonging to class I (under the EU MDR or MDD) must produce a post-market surveillance report, as well as manufacturers of IVD devices which belong to class A or B (under the EU IVDR) and those devices not in the lists in Annex II of the IVDD. Similarly, the SI requires manufacturers of class IIa or class III devices (under the EU MDR or MDD), class C or D devices (under the IVDR) and devices in Annex II List II (under the IVDD) to produce a periodic safety update report. However, this is no mention of whether these higher risk IVDs should receive a report back from the approved body in response to these PSURs. BIVDA believes this is an error in the text, and these devices will also require approved body reports.
Another key divergence from EU legislation, is in submission of PSUR documents. These should be provided to the approved body, who will then be responsible for passing this onto MHRA upon request. The legislation only references approved bodies for this distribution, so there is a lack of clarity on how this will work for manufacturers who do not have an approved body as they are operating under the EU regulatory system.
The MHRA is also actively working on the guidance which will be published to supplement this legislation. They have confirmed that even though this is draft text, a further amendment is expected in 2024 for IVDs specifically in line with planned classification changes under the new UKCA regime.
BIVDA will be holding an ad-hoc UKCA sub-group meeting in the coming weeks to go through this legislation in more detail. Further information on this meeting will be provided in due course.
If you have any questions in the meantime, please send these to regulatory@bivda.org.uk.
