Today the MHRA published a link to the draft ‘Post-market Surveillance Requirements Statutory Instrument’: HERE

Those monitoring the UK legislation may already be aware this was coming – last year the MHRA already announced their intent to implement new Post-market Surveillance (PMS) legislation.

The direct link to the draft is available: HERE

What to expect

The draft legislation introduces:

• • Post-market surveillance system, which must be proportionate to the risk of the device, systematic, proactive, and continually assessed, i, e., it cannot be reactive, and it cannot be written and then filed away to be forgotten
  • Criteria for the post-market surveillance plan and the post-market surveillance report (PMSR)
  • Shorter reporting timeframes for serious incidents
  • Updated requirements for field-safety corrective actions
  • Periodic Safety Update Reports (PSUR), including schedule
  • Trend reporting
  • Retention period for post-market surveillance documentation

The good news for an industry already dealing with so many regulatory changes, postponements, and cobbled-together legislation?  The draft UK PMS requirements are generally in line with the EU MDR/IVDR.

Timeframe for new legislation

The WTO’s website shows the proposed date of adoption as December 2023 and the proposed date of entry into force as June 2024.

This is in line with the MHRA’s website, which states the new legislation is expected “this winter” and is anticipated to apply starting mid-2024.