Switzerland Negotiations with Europe Substantively Concluded, Now Ready for Formal Conclusion
20 December 2024
Update on Timing for Mandatory Use of the ‘swissdamed’ Device Registration Module
2 January 2025The new UK Post-Market Surveillance (PMS) legislation is available: HERE
Overview
It introduces:
- New vigilance terminology and reporting timeframes
- Requirement to develop a PMS system, including PMS Plan and subsequent reports (and how the PMS data should be considered in other aspects of the device, e.g., design and manufacturing, evaluation of clinical data, etc.)
- Trend Reporting, which is the requirement to report if there are any “significant increases in the frequency or severity of incidents involving a device if…that increase could have a significant adverse impact on the required risk analysis” and “any significant increase in expected erroneous results in comparison to the stated performance of the device in the instructions for use [for IVDs]”.
The requirements are generally aligned with the EU MDR/IVDR. This includes the new vigilance terminology and reporting timeframes, as well as admin statements, e.g., the PMS Plan must be “clear, organised and searchable”.
That said, there are a few differences from the EU MDR/IVDR. For example, the Post-market Surveillance Report (Class I medical devices and Class A & B IVDs) must be produced within 3-years of the device being placed on the market/put into service and updated every 3-years thereafter. Meanwhile the MDR/IVDR does not define a specific timeframe, although 3-years is generally considered best practice. For more information, see: What is a Post-market Surveillance Report?
The regulation also provides an itemized list of which sections are applicable to custom-made devices under Section 44ZD.
Timing
The new PMS requirements come into force six (6) months after the day on which it was made, i.e., 16 June 2025.
Watch for the associated MHRA guidance to be amended in the coming months, such as their guidance on vigilance.
