In Great Britain (GB), medical devices are subject to regulation according to the Medical Devices Regulation 2002 (SI 2002 No 618, as amended) (referred to as the UK MDR 2002). Prior to the conclusion of the transition period following the U.K.’s departure from the EU, these regulations incorporated the directives listed below into U.K. law:
- Directive 90/385/EEC concerning active implantable medical devices (EU AIMDD)
- Directive 93/42/EEC relating to medical devices (EU MDD)
- Directive 98/79/EC governing in vitro diagnostic medical devices (EU IVDD)
Consequently, the current pathway for market access in Great Britain and the UKCA (UK Conformity Assessed) marking prerequisites are rooted in the requirements outlined in the aforementioned EU legislation.
The Role of the MHRA #
The Medicines and Healthcare products Regulatory Agency (MHRA) is in charge of regulating, amongst other products, medical devices. The MHRA carries out market surveillance activities for medical devices within the UK market and possesses the authority to make determinations concerning the marketing and distribution of such devices in the United Kingdom. The MHRA holds the responsibility of designating and overseeing UK conformity assessment bodies (CABs).
Medical Device Classification in the UK #
In the UK, medical devices are classified as Class I, IIa, IIb, and III, in increasing order of risk posed by the device type. To classify a medical device, you must refer to the classification rules in Annex IX of the UK MDR. Each rule describes, in very vague terms, a type of device. Depending on which rule or rules apply to your device, the highest classification associated with those rules shall apply.
The route of conformity, and therefore the specific requirements relevant to your devices, will greatly depend on the device classification. Class I medical devices, being the lowest risk device type, have an easier route of conformity than other device types. Higher risk devices will require the assessment from third-party Conformity Assessment Bodies which will review (in depth) whether or not a device complies to all the requirements of the UK MDR.
Conformity Assessment #
UK Approved Bodies have the authority to carry out conformity assessments for medical devices, active implantable medical devices, and in vitro diagnostic medical devices under Parts II, III, and IV of the UK MDR 2002 specifically for the Great Britain market. However, it’s important to note that these UK Approved Bodies do not possess the capability to perform conformity assessments for the CE marking.
Manufacturers of Class I medical devices and general in vitro diagnostic devices (IVDs) have the option to self-declare conformity with the UK MDR 2002. They will then be able to apply the UKCA marking and make their devices available on the Great Britain market.
However, for Class I medical devices that are either sterile or possess a measuring function, manufacturers are required to engage a UK Approved Body to conduct third-party conformity assessments. This step is necessary to ensure compliance with the UK MDR 2002 and to affix the UKCA marking before introducing their devices to the Great Britain market.
CE Marking vs. UKCA Marking #
The UK Conformity Assessed (UKCA) marking serves as a product certification for specific goods, such as medical devices, intended for sale in the Great Britain market (comprising England, Wales, and Scotland). Notably, the UKCA marking does not hold recognition within the EU, EEA, or Northern Ireland markets. Consequently, products destined for these regions must bear the CE marking for lawful distribution.
Whilst originally medical device manufacturers placing their products on the GB market had until June 30, 2023 to affix the UKCA mark, legislators implemented measures to extend the acceptance of CE-marked devices in Great Britain far beyond this date:
- EU MDD/AIMDD-compliant medical devices may be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028;
- EU IVDD-compliant IVDs, may be placed on the GB market up until the sooner of expiry of certificate or 30 June 2030;
- General medical devices, including custom-made devices, compliant with the EU MDR and IVDs compliant with the EU IVDR can be placed on the Great Britain market up until 30 June 2030.
The above only applies to medical devices considered to be legacy devices in the EU.
When third-party conformity assessment is necessary for the UKCA marking, manufacturers must engage a UK Approved Body. However, manufacturers of non-sterile and non-measuring Class I devices and general IVDs have the option to self-certify their products against the UKCA marking requirements.
Registration Process #
All medical devices, including in-vitro diagnostic devices (IVDs), custom-made devices, systems and procedures packs, must be registered with the MHRA prior to being made available on the Great Britain market. These devices must all comply with the UK MDR 2002, with the transitional provisions in place for CE-marked devices, in order to be registered.
The MHRA shall only accept registrations from manufacturers located within the United Kingdom. Manufacturers based outside of the UK must first appoint a UK Responsible Person which shall assume specific responsibilities on behalf of the manufacturer, including the registration of the device with the MHRA.
Northern Ireland-based manufacturers who have already registered their devices with the MHRA for the Northern Ireland market can subsequently introduce them to the Great Britain market without necessitating additional registration procedures in Great Britain.
Prior to registering your devices, you will need access to the MHRA Device Online Registration System (DORS). Your registration with the MHRA will not be considered complete until you have furnished information about the device you intend to register and have obtained confirmation of your device’s registration. It is imperative to maintain the accuracy and currency of all information provided in your MHRA registration. In some instances, the MHRA may require supplementary technical documentation from you to substantiate your product’s compliance with the applicable regulatory criteria before confirming your registration.
It is important to note that registering your devices with the MHRA, which serves as the UK Competent Authority, does not imply any form of accreditation, certification, approval, or endorsement by the MHRA.
UK Responsible Person #
As previously highlighted, for the purpose of placing a device in the market of Great Britain (encompassing England, Wales, and Scotland), manufacturers located outside the UK must designate a UK Responsible Person (UKRP).
The UKRP must furnish documented proof demonstrating their authorization from the manufacturer to act as the UK Responsible Person. Importers and distributors, on the other hand, are not obligated to appoint a UKRP.
The UK Responsible Person acts on behalf of non-UK manufacturers and undertakes specified tasks related to the manufacturer’s obligations. As mentioned previously, this includes the registration of the manufacturer’s devices with the MHRA before these devices can be introduced to the Great Britain market.
The responsibilities of the UK Responsible Person are delineated in the UK MDR 2002. In summary, in addition to the registration requirements mentioned earlier, the UK Responsible Person is required to:
- Ensure that the manufacturer has prepared the declaration of conformity and technical documentation, and, when applicable, that the manufacturer has conducted the appropriate conformity assessment procedure;
- Maintain copies of the technical documentation, declaration of conformity, and, if applicable, the relevant certificate, along with any modifications and supplements, for inspection by the MHRA;
- Provide the MHRA with all necessary information and documentation, upon request, to demonstrate device conformity;
- Comply with any MHRA requests for device samples or access to devices, if available;
- If they do not have device samples or access, convey MHRA requests to the manufacturer and inform the MHRA of the manufacturer’s intention to comply.
- Collaborate with the MHRA on any preventative or corrective actions taken to eliminate or, if not possible, mitigate device-related risks.
- Promptly notify the manufacturer of complaints and reports concerning suspected device-related incidents from healthcare professionals, patients, and users.
- If the manufacturer fails to fulfil its obligations under these Regulations:
- Terminate the legal relationship with the manufacturer.
- Notify the MHRA and, if applicable, the relevant Approved Body of this termination.
There is no restriction preventing an importer or distributor from simultaneously serving as a UK Responsible Person.
Furthermore, the name and address of the UK Responsible Person, when applicable, must be included on product labelling, outer packaging, or instructions for use in cases where the UKCA marking is affixed. However, the UKRP details are not necessary on labelling for CE-marked devices unless the device bears both the CE and UKCA markings.
The Role of a UK MDR Consultant #
Understanding and keeping up to date with UK requirements may be challenging, especially as these seem to be changing month by month. A UK MDR consultant plays a crucial role in helping medical device manufacturers navigate the complex regulatory landscape in the UK. Their primary responsibilities include:
Regulatory Strategy Development: Consultants help manufacturers develop a comprehensive regulatory strategy tailored to their specific medical devices. This strategy outlines the steps required to obtain regulatory approvals and certifications.
Regulatory Submission Preparation: Consultants assist in preparing and compiling the necessary documentation for regulatory submissions, such as UKCA marking applications, technical files, and clinical evaluations. They ensure that these submissions meet UK’s regulatory requirements.
Compliance Assessment: Consultants assess a manufacturer’s existing processes, quality management systems, and documentation to ensure they align with the UK MDR 2002.
Clinical Evaluation and Post-Market Surveillance: Consultants can help manufacturers establish and maintain systems for clinical evaluations and post-market surveillance, which are critical for demonstrating the safety and performance of medical devices over their lifecycle.
Liaison with Competent Authorities: They act as intermediaries between manufacturers and UK CABs, helping to address questions, provide clarifications, and resolve regulatory issues.
Risk Management: Your UK MDR consultant may assist in developing risk management plans and documentation in accordance the UK MDR requirements. This includes conducting risk assessments and implementing risk mitigation strategies.
Training and Education: They provide training and education to manufacturers and their teams to ensure they have a thorough understanding of UK regulation and compliance requirements.
Benefits of Contracting a Regulatory Consultant Over Hiring In-House #
Expertise: Regulatory consultants specialize in the UK MDR and are often experts in their field. They bring a wealth of knowledge and experience, which can be especially valuable for manufacturers navigating complex regulatory requirements.
Cost-Effective: Contracting a consultant can be cost-effective compared to hiring and maintaining an in-house regulatory team. Manufacturers can access expertise on an as-needed basis, reducing overhead costs.
Flexibility: Consultants offer flexibility in terms of engagement duration. Manufacturers can hire consultants for specific projects, regulatory submissions, or ongoing support, tailoring the engagement to their needs.
Time Efficiency: Regulatory consultants are experienced in the regulatory process and can expedite the submission and approval process, potentially reducing time-to-market for medical devices.
Objectivity: Consultants offer an independent perspective, which can be beneficial in assessing a manufacturer’s existing processes and identifying areas for improvement or compliance gaps.
Regulatory Updates: Keeping up with evolving regulatory requirements is challenging. Consultants stay updated on regulatory changes and can help manufacturers adapt to new regulations and guidelines.
Reduced Compliance Risk: Regulatory consultants assist in ensuring that devices meet all regulatory requirements, reducing the risk of compliance-related issues and potential recalls.
Post-Market Surveillance #
After having placed a medical device on the UK market, the manufacturer becomes obliged to submit any vigilance reports to the MHRA when certain incidents occur in the UK in relation to the use of that device. All appropriate action shall be taken in order to bring the device back into compliance or remove the device from the market, to ensure user and patient safety.
The obligation to inform the MHRA about incidents and Field Safety Corrective Actions (FSCAs) that meet the reporting criteria falls upon either the manufacturer, the UK Responsible Person, or the Authorized Representative. This requirement encompasses Periodic Summary Reports (PSR) and Trend Reports. However, the primary responsibility for investigating incidents and implementing any requisite corrective measures lies with the manufacturer.
Manufacturers are required to submit post-market vigilance reports to the MHRA. For adverse incidents concerning devices, these reports can be submitted to the MHRA through the MORE portal. To utilize the MORE portal, it is essential to complete the registration process with the MHRA.
Future Outlook #
The future outlook of UK medical device regulation is one of change and reform. The MHRA is currently developing a new regulatory framework for medical devices in the UK, which is expected to come into force in 2025. The new framework will be based on the principles of risk-proportionality and innovation, and will aim to ensure that patients have access to safe and effective medical devices.
Some of the key changes that are expected to be introduced in the new framework include:
- A new classification system for medical devices, which will be based on the level of risk posed by the device;
- More rigorous requirements for pre-market assessment of high-risk devices;
- Increased focus on post-market surveillance and vigilance;
- Greater transparency and accountability from manufacturers and other stakeholders.
The MHRA has stated that it intends to align the new framework with international best practice, and to ensure that it is compatible with the regulatory frameworks of other countries. This will be important for maintaining the UK’s position as a global hub for medical device innovation and manufacturing.
The future UK medical device regulation is also likely to be influenced by the UK’s relationship with the European Union (EU). The UK has left the EU, but the two sides are currently negotiating a new trade deal. The outcome of these negotiations will have a significant impact on the way that medical devices are regulated in the UK.
If the UK is able to reach a trade deal with the EU, it is likely that CE marked medical devices will continue to be accepted in the UK market. However, in the event a deal is not struck, manufacturers will need to obtain a UKCA mark in order to place their devices on the UK market. The future outlook of UK medical device regulation is therefore one of change and uncertainty. However, the MHRA has committed to developing a new framework that is based on the principles of risk proportionality and innovation. This framework will aim to ensure that patients have access to safe and effective medical devices, while also supporting the growth of the UK medical device industry.