The UK is taking significant steps to reshape its medical device regulatory landscape following post-Brexit. A key development is the post- market surveillance statutory instrument, officially laid in Parliament on October 21, 2024. This draft legislation, titled "The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024,” this draft legislation introduces new post-market surveillance (PMS) requirements for medical devices in Great Britain (GB) by amending the existing Medical Devices Regulations 2002.Expected to take effect on June 16, 2025,this is a crucial component of the UK's broader effort to establish an independent regulatory framework.
It's important to note that medical devices in Northern Ireland will continue to be governed by EU regulations as stipulated under the Northern Ireland Protocol.
This article delves into the nuances of the upcoming changes, highlighting the similarities and critical differences between the new UK PMS regulations and those established by the EU Medical Device Regulation 2017/745 (EU MDR) and the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (EU IVDR).
Resemblance To EU Regulations: A Closer Look
The new UK regulations align closely with the EU MDR and IVDR, particularly in their core principles. This is intended for manufacturers to efficiently implement PMS systems.
Similarities:
However, despite these apparent similarities, manufacturers must exercise caution and avoid assuming complete equivalence.
Differences:
"Manufacturers across Europe should check their planned PMS activities specifically against the UK legislation and not assume they are the same as in the EU."
Subtle yet significant differences exist, demanding meticulous review and adaptation of existing PMS procedures. Crucially, reports generated under the new regulations must be submitted directly to the Medicines and Healthcare products Regulatory Agency (MHRA) and, in certain cases, to the UK approved body and the UK responsible person (UKRP).
Key Differences: UK PMS vs. EU PMS
To provide a clearer understanding of the distinctions, the following table outlines key differences between the UK and EU PMS frameworks:
| Aspect | UK PMS | EU PMS |
|---|---|---|
| 1. Regulatory Framework | Governed by the UK Medical Devices Regulations 2002 (as amended) and the UK MDR 2017. The Medicines and Healthcare products Regulatory Agency (MHRA) oversees PMS in the UK. | Governed by the EU MDR 2017/745 and IVDR 2017/746. National competent authorities and EMA oversee PMS. |
| 2. PMS Documentation | Requires a PMS Plan, Post-Market Surveillance Report (PMSR) for class I devices, and PSUR for Class IIa, Class IIb and Class III devices. (regulation 44ZL, The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024) | Requires a PMS Plan, PMSR (Class I devices), PSUR (for Class IIa, IIb, and III devices), and PMCF evaluation reports. (Article 85 and 86) |
| 3. Reporting Obligations | Serious incidents and FSCAs must be reported to MHRA through the UK’s reporting portal. Reporting timelines of serious incidents are same for both: - no later than 15 days after the manufacturer becomes aware of the serious incident. - no later than 2 days after the manufacturer becomes aware of the serious public threat. - no later than 10 days after the manufacturer becomes aware of the death or an unanticipated serious deterioration in a person’s state of health. | Incidents and FSCAs must be reported through the centralized Eudamed database.(Article 87 Reporting of serious incidents and field safety corrective actions). Eudamed is not yet fully functional. |
| 4. Market-Specific Requirements | Devices require UKCA marking. Manufacturers outside the UK must appoint a UK Responsible Person (UKRP). | Devices require CE marking under MDR. Manufacturers outside the EU must appoint an EU Authorized Representative (EU Rep). Article 11 |
| 5. Incident Definitions | “incident” means in relation to a device that has been placed on the market or put into service— (a) a malfunction or deterioration in the characteristics or performance of the device when used in accordance with the instructions for use, (b) a side-effect that has a negative impact on (i) the health of an individual, (ii) patient management, or (iii) public health,. “PART 4A Post-market surveillance requirements | According to article 2 An ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. |
| 6. Database | No centralised database akin to Eudamed. Data is managed directly with MHRA. | Requires the use of Eudamed for incident reporting and PMS data sharing. Eudamed is not yet fully functional. |
| 7. Retention of PMS Documentation | The minimum document retention period is 15 years for implantable devices, and 10 years for all other devices, all documentation relating to PMS must be retained to the end of the entire PMS period if this exceeds these times (44ZQ). | Manufacturers shall keep the technical document in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market. |
Key Differences in Definitions: Where Vigilance is Paramount
Careful scrutiny is essential due to differences in key definitions between the UK and EU frameworks. Let's examine a few critical examples:
Conclusion
The impending implementation of the post-market surveillance statutory instrument in Great Britain marks a significant shift in the regulatory landscape for medical devices. While drawing inspiration from the EU MDR and IVDR, the UK regulations introduce distinct requirements that manufacturers must thoroughly understand and address. Proactive adaptation and meticulous attention to detail are essential for ensuring compliance and maintaining UK market access.
FAQs
Q: When will the new PMS regulations come into effect in Great Britain?
A: The expected implementation date is June 16, 2025.
Q: Do the new regulations apply to Northern Ireland?
A: No, medical devices in Northern Ireland continue to follow EU regulations under the Northern Ireland Protocol.
Q: How do I report incidents under the new UK regulations?
A: Serious incidents and FSCAs must be reported to the MHRA through the UK’s reporting portal.
Q: Do I need a UK Responsible Person (UKRP) if I am a manufacturer based outside the UK?
A: Yes, manufacturers based outside the UK are required to appoint a UKRP.
Q: Where can I find the full text of the new legislation?
A: The full text of "The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024" can be found on the UK Parliament website.
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