Does the New UK Regulation Affect Devices with CE Marking on the GB Market?
Yes, the new UK PMS regulations does impact medical devices with a CE marking which are currently allowed onto the GB market. This includes devices under:
• EU Regulation 2017/745 (MDR)
• EU Regulation 2017/746 (IVDR)
• EU Medical Device directives
Even though CE-marked devices are still valid in the UK post-Brexit, the UK’s unique regulations now apply in GB, and manufacturers must comply with both local and EU requirements.
Key Points on CE Marked Devices in GB:
• Vigilance reporting, PMS plan, PSUR, and PSRP Requirements:
Devices with a CE marking must still adhere to certain PMS obligations including vigilance reporting, PMS plans, Post-Market Surveillance Reports (PSURs), PMS reports (PMSRs).
• No PSUR Submission to Approved Bodies:
Unlike devices with UKCA marking, CE-marked devices do not need to submit PSURs to the approved body (equivalent to Notified Body in GB). However, the MHRA can request the PSUR, which must be provided within 3 working days.
Note: For devices with CE marking available on the GB market under transition provisions, UK Approved Bodies are not currently involved in any assessments. Please remain vigilant, as this may change in the future under the international reliance program following the 2021 MHRA consultation.
Exemptions and Expectations:
• PMS Data & Risk Management / Technical Documentation:
The use of PMS data as input for the risk management process and updates to Technical Documentation is excluded for CE-marked devices.
o MHRA Expectation: While not mandatory, the MHRA expects manufacturers to still apply the same principles of updating technical documentation for CE-marked devices in GB, ensuring that the PMS system is robust and considers all PMS data sources.
• Exemptions from the regulation:
o Custom-made Devices - Subject to full PMS requirements except for Field Safety Corrective Actions outside GB (44ZK), PMSR (44ZL), PSUR (44ZM), Trend Reporting (44ZN)
o Procedure Pack Manufacturers - Must comply with all PMS requirements, except PMSR (44ZL) and PSUR (44ZM)
• Excluded from the regulation:
o Devices intended for clinical investigations and devices with special authorization from the Secretary of State.
What are the key differences between UK PMS Regulations and EU Regulations?
The UK PMS 2024 Regulations further aligns GB PMS and vigilance requirements with the European Union Regulations. The PMS system structure, based on a PMS plan, is very similar. However, there are key differences, particularly in reporting timelines, documentation requirements, and vigilance processes.
1. Documentation Timelines
If requested by the MHRA, manufacturers and UK Responsible Persons (if applicable) must provide PMS-related documents within 3 working days, including PMS plan, PMSR, PSUR or Approved body review reports (if applicable). This is a more stringent requirement than in the EU, where response times can vary. (regulation 44ZF)
2. Vigilance & Reporting Requirements
• All serious incidents must be reported to the MHRA, even if they involve side effects that are already known and documented in the device’s technical documentation. This differs from the EU, where such incidents may not always require reporting. (Regulation 44ZH)
• Field Safety Corrective Actions (FSCAs):
Manufacturers must notify the MHRA via the MORE system before informing customers and manufacturers and should publish Field Safety Notices (FSNs) on their websites. (Regulation 44ZJ)
• FSCA Outside GB:
If a manufacturer undertakes an FSCA outside GB, and the same type of device is available in GB but not affected, the MHRA must still be notified (unlike in the EU MDR).
o Timeline: 3 working days. (Regulation 44Zk)
• Specified Reporting Requirements: UK law defines the required information for initial and final reports—manufacturers must confirm this before reporting in GB. (Regulation 44ZH & 44ZI)
3. Trend Reporting Obligations
Manufacturers must submit trend reports for serious incidents meeting reporting criteria as well as non-serious incidents that do not meet individual reporting criteria. Reports must be submitted via the MORE portal and reviewed within the PMSR, PSUR.
(Regulation 44ZN)
4. Capturing User Experience as part of the PMS plan
Manufacturers must actively gather user experience data from patients and the public regarding device safety and performance. The PMS Plan must include a process for collecting and assessing this information (which is not explicitly required under EU MDR).
(Regulation 44ZF)
5. Post-Market Surveillance Report (PMSR)
• Similar to EU regulations, however classification depends on the legislation under which the device was placed on the market (MDD/MDR or UK Regulations).
• First PMSR must be prepared within 3 years and updated at least every 3 years until the end of the PMS period - which now has been formally defined.
(Regulation 44ZL)
6. Periodic Safety Update Report (PSUR)
• To group devices in the same PSUR, they must be covered by the same clinical evaluation report and be similar devices.
• A leading device determines the schedule for data collection and the PSUR update frequency for the entire group.
• UK data can be combined in the EU PSUR as long as UK-specific data is clearly identified and content, frequency, and update requirements are fully met. MHRA released a standardised PSUR format guidance.
• Exclusions: PSUR requirements do not apply to custom-made devices or system/procedure packs.
(Regulation 44ZM)
7. Retention of PMS-Related Documentation
• Minimum retention periods remain the same as in the EU:
o 15 years for implantable devices.
o 10 years for all other devices.
• However, in the UK, all PMS-related documentation must be retained until the end of the PMS period, even if it exceeds these timelines. For devices with a longer expected lifetime, the retention period will be longer in GB than in the EU.
(Regulation 44ZC)
8. New Definitions
• Lifetime of a device
• PMS period
• Similar device
• Required risk analysis
(Regulation 44ZC)
9. Diverging Definitions
• “Incident” - More comprehensive than the EU definition, including:
o Side effects with a negative impact on health of an individual, patient management or even public health
o Erroneous result of a diagnostic product that support clinical decisions.
• “Serious Incident” now clarifies that interventions to prevent serious deterioration in health include self-administered treatment
(Regulation 44ZC)
