Background

When the UK withdrew from the EU (“Brexit”), the MDR/IVDR had not yet gone into effect. Therefore, when they left, the legislation was still based on the old EU Directives (MDD/AIMDD/IVDD).

The MHRA announced post-Brexit that they would amend their MDD/AIMDD/IVDD-based legislation and in 2021 opened a consultation. While many proposed elements were aligned with the MDR/IVDR, there were some areas of divergence.

The new legislation was supposed to go into effect July 1, 2023. However, it was then postponed. The major legislative changes are now expected to go into effect in 2025.

In the meantime, the MHRA announced they would push the Post-Market Surveillance changes forward, in advance of the other changes.

The Update

The announcement can be found: HERE

Impact to Manufacturers

The Post-Market Surveillance (PMS) updates include:

• Introducing definitions for ‘serious incident’
• Align serious incident reporting timeframes to the MDR/IVDR, i.e.,
  • Two days after they become aware of the incident, in the event of a serious public health threat
  • 10 days after they become aware of the incident, in the event of death or an unanticipated serious deterioration in a person’s state of health
  • 15 days after they become aware of any serious incident which is not covered under parts (a) or (b) above.
• Require reporting of statistically significant trends
• Outline minimum requirements for Field Safety Notices (FSNs)
• Require manufacturers implement a PMS system, based on developing a formal PMS Plan

For manufacturers already compliant with EU legislation, the changes are not significant and likely easily managed. All manufacturers of CE Marked devices, even MDD/AIMDD/IVDD legacy devices, are required to comply with MDR/IVDR post-market surveillance requirements.

Manufacturers who do not hold CE Marking, and whose devices are only UKCA Marked, will have more work required of them. In addition to updating their vigilance procedure to incorporate new terminology, reporting timeframes, and other new concepts, they also need to develop a PMS Plan. The PMS Plan will outline ongoing requirements, including timing to generate PMS reports / Periodic Safety Update Reports (PSURs).

For more information on the MHRA’s position, please read the MHRA’s ‘detailed response to WTO comments’.

Timing

The amendment to Post-Market Surveillance (PMS) requirements was laid in Parliament on October 21, 2024, as a Statutory Instrument (SI).

This mechanism allows for easier and faster implementation of legislative changes. Therefore, anticipate it becoming effective before the end of the year, followed by a six-month transition period. i.e., compliance by end of Q2 2025.