MHRA Opens Public Consultation on Proposed Changes to Medical Device Regulatory Framework

By Karen Hill

Background

Following the 2021 government consultation on changes to the Medical Devices Regulations 2002 (MDR 2002), and now armed with even more information and experience, on Nov. 14, the U.K. medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a public consultation. The MHRA solicited members of the public, including patients, medical device researchers, developers, manufacturers and suppliers, clinicians and other healthcare professionals, to provide their views on proposals to update the following four areas for the future regulatory framework for medical devices.

International reliance

Currently, medical devices placed on the Great Britain (GB) market need to have either U.K. Conformity Assessed (UKCA) marking or CE marking from the European Union (EU). The arrangement for CE-marked devices is time-limited until June 30, 2030, at the latest, to support the transition following the U.K.’s exit from the EU. It was initially proposed in May that an international reliance scheme to enable swifter market access for certain medical devices that have already been authorized in a comparable country be introduced to complement the UKCA process. Manufacturers would still have the option to use the UKCA process.

Four countries/jurisdictions that have similar regulatory systems to the U.K. have been identified as potential comparable regulator countries (CRCs): Australia, Canada, the EU and the USA. Subject to certain conditions and requirements, manufacturers could rely on the authorizations or certificates issued by regulatory authorities in these countries. The review process proposed now is streamlined in comparison to the UKCA conformity assessment process and comprises four routes proposed access routes, which are further discussed in our next Regulatory Update.

Medical devices must meet a number of preset criteria to qualify for any of these access routes. In addition, certain devices are not eligible for any of these access routes.

UKCA marking

Views are being sought on removing the current requirement that devices that undergo the U.K. conformity assessment process be marked with the UKCA marking.

With the intended introduction of UDI requirements to improve medical device traceability, the MHRA proposes to remove the requirement for UKCA marking on the device or its labeling (e.g., packaging or IFU). This proposal would not impact the conformity assessment process or other marking requirements from other product safety or health and safety legislation.

In vitro diagnostic devices (IVDs)

Following the previous consultation, which included a new classification system for IVDs, the MHRA is proposing an amended IVD classification system that more closely aligns with the structure used by the IMDRF and EU IVDR and will support global harmonization. The new classification system will consist of four classes: A, B, C and D, with Class A being the lowest risk and Class D being the highest risk.
 

*A critical situation is a situation or condition where accurate and/or timely diagnosis or treatment action is vital to avoid death, long-term disability or other serious deterioration of health of an individual patient or to mitigate impact to public health.

In addition, with the aim of ensuring that appropriate patient safety controls are in place that are risk proportionate, the following conformity assessment procedures are being proposed for each IVD device classification:
 

• Class A IVD devices: UKCA self-declaration of conformity
   
• Class B IVD devices: UKCA self-declaration of conformity, and Quality      Management System (QMS) certification
   
• Class C IVD devices: UKCA conformity assessment by an approved body
   
• Class D IVD devices: UKCA conformity testing by an approved body, Batch release testing, and common specification requirements

*If a Class A or B device is required to be sterile then it will need to undergo a conformity assessment by an approved body only for sterility.

This new classification system closely aligns GB with the EU. However, the regulatory requirements to gain market access would be more risk proportionate for GB, in particular for Class B IVD devices which would be self-certified in GB but required to undergo a CE conformity assessment by a Notified Body in the EU.

Assimilated EU law

The MDR 2002 transposed relevant EU Directives into domestic law and is therefore considered to be assimilated EU law. The current proposal is to remove the revocation date of the four following pieces of assimilated law so that they remain part of the statutory framework for medical devices in GB until the transition to an updated medical devices regimen:
 

• Commission Decision 2002/364 on the common specifications for in vitro diagnostic medical devices
   
• Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices
   
• Regulation (EU) No 722/2012 concerning particular requirements for medical devices manufactured utilizing tissues of animal origin
   
• Regulation (EU) No 920/2013 on the designation and the supervision of approved bodies

These are currently due to expire on May 26, 2025, before any new regulations are in force. However, as these regulations are still in use, the MHRA proposes to remove their revocation dates so that they will continue to apply in G.B. until such times as they are replaced with updated U.K. law.

MHRA consultation procedure and timeline

The consultation comprises thirteen Yes/No questions, with the opportunity to provide further optional comments. The consultation is now open and closes on Sunday, Jan. 5, 2025. Responses should be submitted online, although questions can be emailed to: futuredeviceregulations@mhra.gov.uk

Concluding remarks

These are welcome developments. They ensure the continued safety and protection of patients while also contributing to global harmonization and reducing the burden on manufacturers.

If you would like your opinions to be considered, submit your responses before the January deadline.