The MHRA has released its outcome to the ‘Consultation on the future regulation of medical devices in the United Kingdom’. The full response can be found: HERE

In Short

The MHRA noted the high volume of industry requests to align with the MDR/IVDR, in order to alleviate regulatory burden. The MHRA’s response document also indicates the new UK regulation will align to the MDR/IVDR in many, though not all, respects.

Significantly, the UK is granting a further transition period, and will continue to allow CE marked devices onto the market for another 3-5 years. This does not exempt non-UK manufacturers from appointing a UK Responsible Person (UKRP) or all manufacturers from the MHRA registration requirements.

Casus provided more detailed information on the exact transition dates: HERE

Expected alignment to the MDR/IVDR:

• Requirement for a regulatory person
• Similar UDI requirements, including requirement for a Basic UDI-DI
• All manufacturers must have a quality management system, though some may not require a certified QMS
• UK Essential Requirements to largely align to GSPRs

Expected divergence from the MDR/IVDR:

• The UK will require GMDN as the required nomenclature system
• The UK will not include Type Examination or Product Quality Assurance as available conformity assessment routes
• Devices must be entirely equivalent on a biological, technical and clinical basis
• No exceptions for clinical evidence requirements for certain implants, such as screws and wedges

Below we have including highlights from each section.

We recommend reading to the original document if any of the sections are of particular interest to you.

1 – Scope of the Regulations

The MHRA will:

• Expand the scope of the UK medical devices regulations to include devices that, while they do not have a medical claim, carry a similar risk profile. These include: colored (non-prescription) contact lenses, dermal fillers, equipment intended to be used to reduce, remove or destroy fat tissue, lasers for aesthetic purposes, and more.
• Not expand the scope to diagnostic tests without a medical purpose, although they may reconsider this in the future.

2 – Classification

The MHRA will:

• Amend the classification system, likely to align with the EU MDR.
• This includes re-classification of certain medical devices such as surgical mesh and joint replacement devices.
• It will also introduce a Class I reusable classification.

More information on in vitro diagnostic devices and software devices is covered in those respective sections.

3 – Economic Operators

The MHRA will:

• Amend the Essential Requirements to align with the EU MDR/IVDR, noting: “…our intention is to broadly reflect the GSPRs in the UK regulations, tailored to the domestic context.”
• Introduce requirement for manufacturer to have sufficient financial coverage (e.g., liability insurance), to commiserate with the type of device, risk class and size of company.
• Require all medical devices manufacturers, including those of Self-certified and Custom-made devices, to implement a quality system (though it may not have to be certified by a registrar/notified body).
• Make the UK Responsible Person legally liable for defective devices on the market on the same basis as the manufacturer.
• Introduce obligations on importers and distributors.
• Require economic importers inform the MHRA if they become aware of any issues that may interrupt supply or cause a shortage of devices on the UK market.
• Require manufacturers and UK Responsible Persons to designate a Qualified Person (similar to an EU Person Responsible for Regulatory Compliance).

4 – Registration and UDI

The MHRA will:

• Require importers and distributors to achieve appropriate levels of device traceability.
• Use Global Medical Device Nomenclature (GMDN) codes as its nomenclature system (will not recognize European Medical Device Nomenclature (EMDN) codes).
• Require a Unique Device Identification (UDI) system.
• Require a Basic UDI-DI and “require the UDI or Basic UDI to be provided in circumstances that are aligned with those stipulated in the EU MDR and IVDR.”
• Introduce a comprehensive registration database, including for vigilance, post-market surveillance and market surveillance.
• Open up who is allowed to enter registration data; currently only UK-based manufacturers or a designated UK Responsible Person may enter registration data.
• Introduce a UK version of the EU Single Registration Number: “…economic operators will need to be issued with a unique MHRA-generated number.”

5 – Approved Bodies

The MHRA will

• Increase the requirements placed on UK Approved Bodies (similar to an EU Notified Body). They will further allow Approved Bodies to conduct fully remote or hybrid audits of their clients in certain situations.

6 – Conformity Assessments

The MHRA will:

• Remove batch verification, product quality assurance and type examinations as available conformity assessment routes.
• Increase scrutiny on implantable devices, including that Class IIb implantable devices (except for sutures, staples, dental filings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) are subject to full technical documentation review, instead of representative review.
• Require Class I reusable surgical instruments undergo review through a UK Approved Body.
• Allow Approved Bodies to impose restrictions or requirements on the use or follow-up of certain medical devices.
• Outline the minimum content requirements for the Declaration of Conformity.

7 – Clinical Investigations and Performance Studies

The MHRA will:

• Introduce requirements that devices be entirely equivalent* on a biological, technical and clinical basis.
• Require a Performance Evaluation Report (PER) as part of an IVD’s technical documentation file.
• Introduce additional requirements for clinical investigations and performance studies.

*The MHRA openly notes that “this approach will take us beyond the equivalence requirements in the EU MDR.” And that while industry requested alignment with the EU MDR, they feel this requirement is necessary to mitigate ‘product creep’.

8 – Post-market Surveillance, Vigilance, Market Surveillance

The MHRA will:

• Strengthen the post-market surveillance system as a whole.
• Introduce definitions for ‘serious incident’, ‘serious deterioration’ and ‘serious public health threat’.
• Require trend reporting.
• Outline the minimum content for Field Safety Notices.

9 – In vitro Diagnostic Medical Devices

The MHRA will:

• Amend the classification system, aligning with the IMDRF IVD classification structure: IMDRF/IVD WG/64FINAL:2021
• Introduce classification rules for companion diagnostic devices, factoring in both the EU IVDR and IMDRF approaches.

*The MHRA notes the rationale that “this will support global harmonization efforts.” Since leaving the EU, the UK has become a IMDRF Management Committee member.

10 – Software as a Medical Device (SaMD)

The MHRA will:

• Add a new definition of ‘software’ to the UK medical device regulations, as “a set of instructions that processes input data and creates output data.”
• Strengthen regulatory requirements and guidance related to distance sales.
• Amend the classification rules to include the IMDRF* SaMD classification rule for general medical devices.
• Introduce an ‘airlock’ rule, allowing temporary classification to a SaMD where the risk profile is unclear. This is to allow early market access for novel and innovative SaMD.
• Separate out Essential Requirements/GSPRs for software, but subdivide the Essential Requirements/GSPRs for software, generally mirroring the EU MDR/IVDR.

*The MHRA notes that they are out of alignment with other major regulators when it comes to classification of software as a medical device and “wants the UK to be in international alignment.”

11 – Implantable Devices

The MHRA will:

• Not grant exceptions for clinical evidence requirements for certain implants, such as screws and wedges – despite industry request to align with the exceptions granted in the EU and US. The MHRA will take the more stringent approach, and requirements will be higher than the EU MDR.
• Take measures to improve traceability.
• Require longer/lifelong patient follow-up.
• Reduce the ability for manufacturers to rely on equivalence to predicate devices as part of the pre-market approval process.

12 – Other Product Specific Changes

The MHRA will:

• Prohibit the re-manufacturer of Class I single-use medical devices. This will not impact devices which are intended for reuse.
• Include the term ‘kit’ into the regulations, along with ‘system’ and ‘procedure pack’; and require that the required procedures be outlined in the assembler’s statement/declaration.
• Require that components which make a significant change to the safety and performance of a medical device be regulated as a medical device in its own right.
• Custom-made devices will be subject to more stringent requirements, such as more robust post-market surveillance system, and a requirement for all custom-made device manufacturers to implement a quality management system (QMS), with Class IIb and III device manufactures requiring a certified QMS.

13 – Environmental Sustainability and Public Health Impacts

The MHRA will:

• Broaden the circumstances in which electronic instructions for use may be used, instead of printed instructions.
• Update the Essential Requirements to require that devices “…must be designed and manufactured in a way that reduces, as far as possible, the risks posed to public health by substances or particles that may be released from the device including wear debris, degradation of products and processing residues.”

14 – Alternative Routes to Market

The MHRA will:

• Implement a pre-market approval route that allows for innovative medical devices to be put into service for a specified time-period and for specific use cases.

15 – Transitional Provisions

Casus wrote a detailed overview of this: HERE

The gist is that the MHRA is providing a longer 3–5-year transition period to allow CE Marked devices onto the market. The exact timeframe depends on if the device is CE Marked to the old Directives or the MDR/IVDR.

This means that if companies have valid CE Marking, they have a longer time period before they must transition to UKCA marking. This does not exempt non-UK manufacturers from appointing a UK Responsible Person (UKRP) or all manufacturers from the MHRA registration requirements.