MHRA wants feedback on updating IVD, medical device regulatory framework
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has wants public input on reforming its regulatory framework for medical devices and in vitro diagnostics (IVD).MHRA has opened public consultation asking stakeholders for input on a new international reliance scheme for products already approved in comparable regulator countries (CRC), new requirements for the UK Conformity Assessed (UKCA) marking, regulatory requirements for IVD devices, and removing the revocation date on certain assimilated European Union (EU) laws. The agency had previously announced it would launch its consultation by the end of the year (RELATED: MHRA to launch consultation on device international reliance plan by year’s end, Regulatory Focus 16 October 2024).
“The measures in this consultation are a small but important part of a wider set of reforms to the regulatory framework for medical devices,” Baroness Gillian Merron, parliamentary undersecretary for patient safety, said in a ministerial forward in the consultation document. “In due course, we will be consulting on further enhancements to the regulatory framework that will drive forward our health and economic growth agendas.”
International reliance
One major proposal by MHRA involves a new international reliance route to put devices on the Great Britain (GB) market as the existing international recognition standard is phased out. Under this route, devices that have been approved by or received a certificate from regulatory authorities in the US, Canada, EU and Australia can be placed on the GB market without needing to obtain a UKCA marking or certification (RELATED: MHRA proposes recognition path for devices cleared by trusted regulators, Regulatory Focus, 21 May 2024).
Products that go through the international reliance route would still need to be registered with MHRA and adhere to any relevant postmarket surveillance regulations. More specifically, in order to qualify, they would have to fall within the scope of UK Medical Devices Regulations; have a unique device identifier (UDI); and follow all requirements for medical device classification, labeling and packaging, and other product requirements.
MHRA proposed four access routes for products under international reliance. Route 1 includes low-risk devices such as Class I and non-sterile Class A IVDs compliant with legislation in the US, Canada, EU, and Australia. Under this route, there is no requirement for approved body review, but the manufacturer must send MHRA an appropriate Quality Management System (QMS) self-declaration when registering the product.
Route 2 includes non-active EU Medical Device Regulation (MDR) devices or In Vitro Diagnostic Regulation(IVDR) tests such as Class Is/m, IIa, IIb, III, and sterile Class A IVD devices as well as Class B, Class C, and Class D IVD devices. Under this route, the approved body must confirm the marketing authorization in a CRC, the device’s GB classification, any relevant GB requirements, the product’s postmarket surveillance plan, and any postmarket surveillance data within the last 5 years.
Route 3 devices are those that are non-active and compliant in Australia, and in Canada under a Class III or IV license, or in the US under de novo authorization, premarket approval or 510(k) clearance. These include Class Is/m, IIa, IIb, and some Class III devices as well as Class B, Class C IVD devices, and sterile Class A IVD devices. Devices under Route 3 need to meet all the requirements outlined under Route 2, meet UK MDR requirements for implant cards and patient leaflets, and contains instructions on reuse if applicable.
Route 4 devices are 510(k) compliant Class IIa, and some Class IIb devices, some Class III and IV license devices in Canada, and Class D IVD devices compliant in the US, Canada, and Australia. The devices in Route 4 must meet all requirements for Route 3 access and ensure the 510(k) cleared devices have a rationale for equivalence under new UK MDR requirements in addition to having a quality and safety opinion from the Secretary of State in cases of incorporated ancillary medicinal substances. Route 4 devices also need to meet requirements for batch test release, software as a medical device (SaMD), and GB electrical requirements.
UKCA marking, IVD devices
MHRA is also proposing to change the UKCA marking requirement, which the consultation document notes “potentially creates a barrier to market for manufacturers” because of the requirement to have a UKCA-marked product line specifically for the GB market.
“As the new UDI requirements would improve the traceability of medical devices, the MHRA propose to remove the requirement for UKCA marking for devices which have been through the UK conformity assessment process,” the consultation states.
Another proposed change is how MHRA would categorize IVDs in risk classes. The new proposal involves having four risk classes, with Class A being the lowest risk devices and Class D having the highest risk to individual and public health.
For market access, Class A IVD devices would need to obtain a UKCA self-declaration of conformity, Class B devices would need a QMS certification in addition to the UKCA self-declaration, Class C devices are required to have a UKCA conformity assessment from an approved body, and Class D devices would have batch release testing and common specification requirements as well as an approved body UKCA conformity assessment.
Removing EU law revocation dates
MHRA also proposed removing the revocation date for four pieces of EU assimilated law until a regulatory framework is established. The four EU laws include Commission Decision 2002/364 on common specifications for IVD medical devices, Commission Regulation 207/2012 describing electronic instructions for use of medical devices, Regulation No 722/2012 on requirements for medical devices that use animal tissue, and Regulation No 920/2013 on requirements for the designation and the supervision of approved bodies.
“As these regulations are still in use, the MHRA proposes to maintain the regulatory status quo by removing the revocation date of these four pieces of assimilated law so that they continue to apply in GB until such time as they are replaced with updated UK law,” the consultation stated. “Allowing these regulations to be sunsetted on 26 May 2025 would cause significant disruption to the regulatory framework and, consequently, negative impacts on patient safety.”
MHRA is accepting responses to the consultation through 5 January 2025.
Consultation
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