The Medicines and Healthcare products Regulatory Agency (MHRA) has published detailed guidance dedicated to the new regulations that will take effect from January 1, 2021. Starting from the aforementioned date, the authority would be fully responsible for all regulatory issues associated with medical devices intended to be marketed in the UK.
Scope of the Guidance
The present MHRA guidance covers the following aspects:
- Certification of medical devices,
- Conformity assessment and marking,
- Registration of a medical device with the MHRA.
The document provides a general overview of the regulatory approach to be applied for medical devices in the context of Brexit. The particular legislative acts implemented the principles described therein are still to be adopted. It is also important to mention that different rules should be applied depending on the particular region of Great Britain.
Medical Device Marketing in the UK: Key Points
The MHRA outlines the key points to be considered by the medical device manufacturers and their authorized representatives intended to market their devices in the UK. In particular, these points include the following ones:
- CE marking placed on the medical device under the applicable EU regulation to indicate that the particular device in question complies with the applicable safety requirements will remain admissible in the UK till June 30, 2023.
- The certificates issued by the duly designated notified bodies located within the territory of the European Economic Area would remain admissible in the UK till June 30, 2023, as well.
- The manufacturers interested in placing their devices on the UK market would be able to use an entirely new regulatory framework starting from January 1, 2021. Starting from this date, any and all medical devices intended to be marketed in the UK should be duly registered with the MHRA. However, this requirement would be implemented in several consequent steps, namely: (i) the shortest period – 4 months – would be applied in case of medical devices with the highest associated risk: Class IIIs and Class IIb implantable medical devices, as well as all active implantable medical devices, (ii) a longer period – 8 months – would be applied in case of other Class IIb and all Class IIa medical devices, and (iii) the longest period – 12 months – would be applied for Class I medical devices (including ones already regifted with the MHRA) since such devices are associated with the lowest risk.
- Foreign medical device manufacturers would have to establish an authorized representative – a UK Responsible Person – who will be in charge of medical devices marketed in the UK and all compliance issues associated thereto.
UK Regulations on Medical Devices
The MHRA guidance also provides details regarding the applicable legislative acts establishing the rules and requirements in the sphere of medical devices. Nowadays, the legal framework includes:
- The Directive 90/385/EEC on active implantable medical devices (AIMDD),
- The Directive 93/42/EEC on medical devices (MDD), and
- The Directive 98/79/EC on in vitro diagnostic medical devices (IVDD).
The provisions set forth under the aforementioned directives are actually implemented in the UK national medical devices legislation by the Medical Devices Regulations 2002. This act would also remain valid within the whole transition period.
It is also important to mention that the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) would not be applicable in the UK.
However, the UK regulation in the sphere of medical devices would not remain unchanged. The MHRA has already announced the intent to accelerate the further improvement of the existing regulatory framework in order to ensure the highest level of public health protection. In particular, the new Medicines and Medical Devices Bill would form a basis of the new regulations in the sphere of medical devices, according to which the safety of the patients would have the highest priority. In order to collect additional information, the MHRA would conduct public consultations with the industry representatives, so the comments and suggestions regarding the potential ways to improve the medical devices regulations would be considered by the MHRA when developing a new version of the regulations.
As was already mentioned before, the MHRA as a regulating authority would remain responsible for all regulatory procedures associated with importing, manufacturing, distributing, and using medical devices. In particular, the authority would perform market surveillance and provide the applicants with the appropriate marketing authorizations approving the devices for distribution in the UK. Apart from this, the MHRA would act as a designating authority in the context of UK Conformity Assessment Bodies.
Requirements for the Medical Device Manufacturers and Suppliers in the UK
One of the most important aspects covered by the MHRA guidance on the new UK medical devices regulations is related to the requirements for and responsibilities of the entities involved in operations with medical devices, including the medical device manufacturers and suppliers distributing medical devices in the UK.
As a first step, any and all medical device manufacturers should duly register with the MHRA. As it was already mentioned before, foreign manufacturers would also have to appoint an authorized representative to act on their behalf. The main responsibility of the medical device manufacturers is to achieve and sustain compliance with the applicable conformity assessment requirements for medical devices.
Registration of Medical Devices in the UK
According to the applicable regulations, starting from January 1, 2020, any and all medical devices intended to be marketed in the UK should be duly registered with the MHRA. In order to be eligible to apply for the registration of a medical device, the manufacturer shall have a place of business in the UK. Hence, the manufacturers registered outside the UK would have to appoint an authorized representative who will be responsible for the medical device during its whole lifecycle. This requirement should be also subject to the same grace period described hereabove as the rules on registration of medical devices in general.
Apart from the aforementioned rules and registration periods, the FDA also states that regulatory requirements for custom-made medical devices should be based on their class under the risk-based classification. In case if the manufacturer or its authorized representative would fail to perform the registration within the appropriate term, such medical devices should not be longer marketed in the UK.
UK Responsible Person
In order to be allowed to market its medical devices in the UK, the manufacturer shall appoint an authorized representative – a UK Responsible Person who will perform all necessary actions on behalf of the foreign manufacturer as required to sustain compliance with the applicable UK medical devices regulations. In particular, the UK Responsible Person will have to:
- Ensure the availability of all documentation confirming that the medical device has successfully passed the conformity assessment and meets the applicable safety and performance requirements,
- Keep a copy of the technical documentation,
- Provide the regulating authority with the additional information upon request,
- Forward the requests directly to the manufacturer (if necessary),
- Implement preventive or corrective actions,
- Inform the manufacturer about any complaints received with regard to the medical device placed on the market, and
- Terminate the agreement with the manufacturer in case if the latter fails to comply with the applicable requirements.
Summarizing the information provided here above, the present MHRA guidance describes the most important aspects of the UK regulation on medical devices and also the specifics of the transition period to be considered by the medical device manufacturers and other parties involved.
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