The United Kingdom has adopted a final version of a regulatory framework for medical devices to be in force after Brexit. The new legislation prescribes the approaches to be applied with regard to the regulatory procedures associated with placing medical devices on the UK market, post-market surveillance, record-keeping and maintenance of databases, special corrective and preventive actions, as well as the suctions the parties involved could be subject to in case if they fail to comply with the applicable regulatory requirements.
The updated regulations are intended to ensure the safety and effectiveness of medical devices in the post-Brexit conditions, and also the uninterrupted availability of vitally important medical devices in changing regularly environment. The present revision pays significant attention to the aspects related to the post-market surveillance and regulatory procedures associated thereto. Moreover, it also expands the requirements on disclosure by outlining the scope of information to be provided to the regulating authorities upon request.
The first draft versions of the new legislation have been initially published almost a year ago, so it actually took up to one year for the lawmakers to finalize the regulatory requirements. In the course of this process, they have considered the recommendations and suggestions submitted by the industry representatives and other parties involved in operations with medical devices, including associations and international organizations.
Medicines and Medical Devices Act 2021
The new regulation named “Medicines and Medical Devices Act 2021” finalized in February 2021 establishes the regulatory approach to be applied for medicines and medical devices for human use and veterinary medicine. The scope of the document covers general health and safety considerations, as well as the procedures to be undertaken by the authorities entitled to amend the regulations and introduce new regulatory requirements. For instance, the regulation outlines the powers and responsibilities of the Commissioner for Patient Safety.
Part 4 of the Medicines and Medical Devices Act 2021 provides detailed regulatory requirements to be applied for medical devices intended to be marketed and used in the UK. First of all, it prescribes that the Secretary of State is entitled to implement new regulations necessary to ensure the safety and availability of medical devices, as well as to establish a favorable environment for the research and development, as well as manufacturing medical devices in the UK.
One of the most important aspects of the new regulatory framework relates to the information systems to be introduced in order to ensure efficient data exchange in the sphere of medical devices. In this regard, the Act prescribes that the Health and Social Care Information Centre shall be responsible for establishing the information systems for the purposes related to:
- The safety and performance, including the clinical effectiveness, of medical devices that are placed on the market,
- The safety of individuals who receive the clinical effectiveness, of medical devices that are placed on the market,
- The improvement of medical device safety and performance through advances in technology.
Thus, the regulatory requirements outline the scope of information to be stored in the context of record-keeping, as well the information to be provided to the Information Centre, and also prescribe the procedures to be applied in terms of mandatory information disclosure.
According to the Act, the Secretary of State is also entitled to establish a committee to advise on device-specific aspects. In such a case, the Secretary of State would specify the number of members of such a committee, the eligibility criteria to be applied, as well as the way the committee shall cooperate with other bodies and authorities.
Enforcement and Notices
Another important matter addressed in the Act relates to the enforcement actions the regulating authority may apply in case of identified non-compliance with the regulatory requirements a medical device shall meet in order to be allowed for marketing and use in the UK.
By sending a compliance notice, the regulating authority may:
- Identify the regulatory requirements in question,
- Indicate the reasons the authority suspects the non-compliance with the aforementioned regulatory requirements,
- Request a responsible person to restore compliance and indicate the particular period of time within which compliance should be restored,
- Request a responsible person to submit, within the specified period of time, sufficient evidence demonstrating that compliance was successfully restored,
- Require a person responsible for a medical device in question to take other actions reasonably necessary to achieve and sustain compliance with the applicable regulatory requirements.
Under the general rule, a responsible person would have at least 28 days to conduct the actions requested by the regulating authority and indicated in the appropriate compliance notice.
A compliance notice described hereabove could be provided to the medical device manufacturer or its authorized representative, or in certain cases to them both.
Another type of action the regulating authority is entitled to take to ensure the safety of medical devices placed on the market is a suspension notice, by the virtue of which the authority requires a responsible person to take the measures indicated therein to restrict the availability of medical devices. According to the regulation, a responsible person cannot, without the explicit consent of the regulating authority, commit the following actions:
- Supply medical device,
- Offer to supply it,
- Agree to supply it,
- Expose it for supply,
- Possess it for supply.
Such notice shall contain the indication of the particular reasons for implementing the measures and the period within which such measures should be actually implemented by a person responsible for a medical device in question. According to the Act, the period of time prescribed in a suspension notice should not exceed 6 months. At the same time, the regulating authority is also entitled to revoke a suspension notice or reduce a suspension period imposed thereby.
In case of a safety notice, the regulating authority may additionally require the responsible person to communicate a warning informing all the parties involved in operations with the medical device in question about potential safety-related issues associated thereto. In some cases, by the virtue of a safety notice, the regulating authority may require the person responsible for a medical device to initiate a recall. As in the case with other notices described hereabove, a safety notice shall indicate the grounds for actions prescribed therein and could be also revoked or modified by the regulating authority.
As it was mentioned before, the updated legislation pays special attention to the regulatory requirements related to the information on medical devices. According to the Act, the regulating authority may provide an information notice requiring the person responsible for a medical device to provide the information about the medical device in question the authority reasonably needs to determine whether compliance, suspension, or safety notice should be served or revoked. By the device of an information notice, the regulating authority may require to disclose the information requested therein or to prepare the records requested and make them available to the representative of the regulating authority.
Summarizing the information provided here above, the updated regulatory framework improves the measures and procedures introduced to ensure the safety and effectiveness of any and all medical devices marketed and used in the UK.
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Sources:
https://www.legislation.gov.uk/ukpga/2021/3/enacted/data.pdf
