The Medicines and Healthcare products Regulatory Agency (MHRA) published its consultation response in June 2022. To the relief of the majority of stakeholders in this area, this will result in new regulations for the United Kingdom that broadly align with the EU Medical Devices Regulations and the In Vitro Diagnostic Device Regulations that came into force in the EU in 2021 and 2022 respectively.
The current UK regime falls under the Medical Devices Regulation 2002 (as amended) and the Medicines and Medical Devices Act 2021 with new regulations initially proposed for 2022.
The timeframe for new regulations has recently been extended by the MHRA with the following current deadlines:
Definitions: The MHRA intends to amend the definitions of medical devices and IVDs in line with the EU regime and international guidance including expanding the definitions to include products such as dermal fillers.
Classification for medical devices (MDs): Medical devices classification rules will be aligned to the rules in the EU MDR including that the intended purpose of a medical device should be construed objectively using both label data, instructions for use, promotional materials (if applicable) and other key materials such as a manufacturer’s technical documentation.
Essential requirements for MDs: These requirements are especially related to safety and performance of medical devices.
Unique Device Identifiers (UDIs): the MHRA will implement a UDI system for medical devices that closely aligns to the EU requirements for UDIs to protect patient safety.
Assessment of MDs: The rules and approach to clinical trials and performance evaluations proposed are broadly consistent with the EU regulations.
Manufacturer, distributor and importer obligations: These obligations and requirements will be aligned with the obligations under the EU Regulations. The definition of Health Institution for the in-house manufacture of medical devices is consistent with the EU regime and the introduction of additional measures to regulate in-house manufactured devices.
UK responsible person: This role of and the requirements for a UK responsible person will be equivalent to an EU authorised representative.
Classification for in vitro diagnostics (IVDs): The classification regime for IVDs will align more closely with the principles set out by the International Medical Device Regulators Forum rather than the EU IVDR.
Alternative routes to market: The consultation response was very supportive of alternative routes to market and the MHRA will proceed with its proposal to implement alternative conformity assessment routes. This will enhance supply and avoid shortages to provide flexibility for the UK regulatory system.
Participation in the Medical Device Single Audit Program (MDSAP) will make the UK part of a multi-country route to market as the MDSAP allows a single regulatory audit certificate from an auditing organisation to be recognised in all participating countries.
The current MDSAP members are:
The MHRA is an observer to MDSAP but MHRA membership would allow this efficient route to market to be used. It should be noted that all of the current UK approved bodies are also approved auditing organisations under the MDSAP.
Domestic assurance will also be implemented as another alternative route to market. In this case, the MHRA will allow an abridged assessment for approval of medical devices with data from another regulatory agency. This will be subject to an appropriate level of scrutiny of the evidence provided. UK approved bodies will be able to reject applications under the domestic assurance route if they do not consider the evidence sufficiently robust to undergo assessment via this route.
Software as a medical device (SaMD): The consultation response confirmed that the UK will be following the SaMD classification guidance for general medical devices (but not IVDs) published by the International Medical Devices Regulatory Forum. In the EU the guidance for Medical Device Software (MDSW) is published by the European Commission’s Medical Device Coordination Group (MDCG). Although the guidance and essential requirements are similar, the UK has clearly stated its intention to comply with the IMDRF’s guidance and nomenclature rather than the EUs.
The MHRA has recently published its work programme for the regulation (wider guidance, policy and standards) of health-related software and AI. This will be the subject of our next article on this important area.
DEKRA has recently been approved as new notified body in the UK for conformity assessments for marking products. This is the first new notified body since Brexit. DEKRA approval is a Part II designation which covers assessments for general medical devices. DEKRA is also an approved auditing organisation under the Medical Device Single Audit Program (MDSAP).
Capacity in the UK medical device conformity assessment system remains an issue. The MHRA is also working ‘proactively’ with an additional six organisations to hopefully add additional notified bodies to the UK system.