The New UK MHRA Medical device regulations: impact to ivd manufacturers

As previously discussed in NAMSA’s blog post, “New UK MHRA Medical Device Regulations Published,” on 28 June, the UK’s Medical Devices and Healthcare Regulatory Authority (MHRA) released its long-awaited report following consultation regarding the future regulation of medical devices in the United Kingdom.

Published on 26, June 2022, the new UK regulations aim to improve the safety of medical devices while also managing fast-moving developments to enable innovation in conjunction with international regulations and standards. (At present, these regulations apply only to Great Britain [England, Scotland and Wales] with Northern Ireland currently covered by the Northern Ireland protocol/aligned with EU legislation.)

Within the new UK MHRA Medical Device Regulations, In Vitro Diagnostic (IVD) products are covered in Chapter 9. Nevertheless, other sections of the report include both IVDs and medical devices with the exception of Chapters 2 and 11, which are solely dedicated to medical devices.

Impact to In Vitro Diagnostic (IVD) Manufacturers
Within this blog post, we will highlight IVD-specific issues, including areas of difference between the new MHRA regulations in contrast to EU regulations—and more specifically, the IVDR/MDR. We will also discuss new areas related to innovation/routes to the UK market and processes put in place to ensure that IVD devices are available on the UK market after the implementation date of the UKCA (1 July 2023).

Significant Differences between the IVDR and UKCA

1. GMDN nomenclature will be used instead of EMDN, and will be relevant for registration purposes.
2. A Great Britain Medical Database will be set-up in the future; this database will be similar to the EUDAMED database presently under construction.
3. UK-Approved Bodies will be allowed to conduct off-site/hybrid audits for specifically defined and justified circumstances.
4. Conformity Assessment – Type Examination (IVDR: Annex X) and Product Quality Assurance (IVDR: Annex XI) will not be available under the UKCA
5. The UKCA regulation does not, at this time, introduce requirements for distance sales of medical devices.

 Areas of Similarity with the IVDR

The following areas have requirements which, if not exactly the same, are very similar to the requirements of the IVDR. These include:

• Definition: Expanded to include Software, companion diagnostics (CDx) and genetic tests
• Classification: Alignment with IMDRF principles and a risk-based approach (i.e., genetic tests will be classified as Class C), with the introduction of CDx-specific classification rules
• ERs/GSPRs: The UK ERs will reflect the GSPRs in the IVDR
• SSCP (SSP in IVDR) and PSUR for high-risk IVD devices
• ‘In-House’ Products: Definition of health institutions and requirements similar to IVDR (i.e. meet ERs, exemption of UKCA marking)
• PMS Plan, PMPF and PSUR requirements are similar to the IVDR
• Clinical performance studies aligned with IVDR and ISO 20916
• Vigilance/Trend Reporting, although the definition for “serious incident” has been modified
• Conformity Assessment: Batch verification for Class D IVDs
• QMS: All manufacturers, including health institutions, must have a QMS (however, a certified QMS is not required for health institutions)

Other areas with similar requirements to the EU legislation (IVDR and MDR):

• Obligations of Importers, Distributors and UKRP
• Requirement for ‘Qualified Person’
• UDI requirements (i.e., require Basic UDI-DI)
• Registration: All Economic Operators will receive a unique MHRA-generated number
• Document retention times aligned with MDR and IVDR requirements

Transitional Arrangements
Based on lessons learned from MDR/IVDR implementation in the EU, the MHRA has taken significant measures to allow products to remain on the market until 1 July 2028 (products which already have conformity markings—either UKCA or CE).

For UKCA-Marked Devices:

• IVD products with current UKCA certificates or DoCs can be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner.

For CE-Marked Devices:

• CE-marked IVD products with valid certifications/DoCs under the IVDR can be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner. This will apply even if the certification/DoC is dated after the new regulations take effect.
• CE-marked IVD products with valid certifications/DoCs under the In Vitro Diagnostic Directive (IVDD) can be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner.

Two caveats will apply to all three transitional arrangements, which are somewhat aligned with Article 110(3) of the EU IVDR:

• Devices that are subject to significant changes in design or intended purpose will be excluded from these provisions.

• All post-market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitionary arrangements.

Also of importance to note is that there aren’t provisions for transitional arrangements for Performances Studies (Chapter 7) due to the significant changes to regulatory provisions being proposed in this area.

Conclusion

While the new UK MHRA Medical Device Regulations aim to closely align with the EU IVDR/MDR regulations, the proposal is an ambitious one, particularly in relation to innovative products and alternative routes to the UK market.

If at first glance there appears to be close similarity between the UK and EU regulations—allowing for Approved/Notified bodies to work just a little bit easier—the UK MHRA differences still obligate manufacturers to create and maintain separate documentation for each market. Additional and specific UK labelling requirements, which were not addressed in this consultation exercise, could be one of the biggest challenges to product transition.

The MHRA proposals for grace periods for existing UKCA, IVDR and IVDD certificates and declarations will certainly be welcome by IVD manufacturers, and provide various stakeholders involved, including MHRA, sufficient time to adapt to these changes. This will help ensure that there are no shortages of medical devices following July 2023.

The proposed regulations do reference further and/or new guidance, which are assumed to be published in the near future. Going forward, it is strongly recommended that UK IVD manufacturers monitor this situation as some areas are in the proposal stage with more in-depth details to be published.

Additional Resources
If you are seeking additional IVDR resources, please visit: https://namsa.com/resources/ivdr-planning/. We also invite you to sign up for a complimentary consultation with one our IVD experts here.