The Medicines and Medical Devices Act 2021 (the Act), adopted on February 11, 2021, constitutes one of the basic elements of the UK`s legislation in the sphere of medical devices. The document outlines the rights and responsibilities of a Commissioner of Patient Safety with regard to medical devices and prescribes the regulatory requirements applicable thereto.
The Commissioner for Patient Safety
The first part of the Act provides general information about the position of a Commissioner for Patient Safety. According to the Act, the Secretary of State shall appoint a Commissioner for Patient Safety (the Commissioner) to be responsible for ensuring the safety of any and all medical devices allowed for marketing and use in the UK.
General Regulations on Medical Devices
The fourth part of the Act addresses the regulatory aspects related to medical devices. It is stated that the Secretary of State is entitled to make amendments to the Medical Devices Regulations 2002, should it be reasonably necessary to enhance the level of public health protection and ensure the safety of patients. At the same time, it is important to keep the proper balance with regard to:
- Ensuring the safety of any and all medical devices allowed for marketing and use in the UK,
- Ensuring the uninterrupted availability of medical devices and avoiding shortages in supply,
- Creating favorable conditions for those engaged in research in the sphere of development, manufacturing, and supply of medical devices.
As described above, the Secretary of State has a right to introduce new regulations related to:
- Regulatory requirements medical devices should comply with in order to be allowed for marketing and use in the UK, including the ones for products themselves (e.g., design, composition), as well as for the responsible parties (e.g., manufacturers, suppliers);
- Conformity assessment procedures to be carried out in order to determine whether the medical device in question meets any and all applicable requirements;
- Designation of the parties responsible for conformity assessment;
- Declarations of conformity medical device manufacturers may make in order to demonstrate compliance with the applicable regulatory requirements;
- Evidence to be provided to demonstrate and confirm compliance;
- Labeling and packaging of medical devices, as well the information they should be accompanied with (e.g., instructions for use);
- Registers of medical devices, their manufacturers, and suppliers;
- Evaluation of the safety, performance, and effectiveness of medical devices when used for the intended purpose;
- Post-marker surveillance of medical devices.
It is also stated that the requirements falling within the scope of matters listed above could also contain references to the applicable international agreements or standards describing the appropriate aspects.
Additionally, the Secretary of State is allowed to introduce new requirements in terms of fees payable by the parties involved in operations with medical devices in connection with certain regulatory actions; as well as on the record-keeping and documenting the actions related to medical devices.
In case of an emergency, the Secretary of State is entitled to indicate the requirements that could be waived in order to ensure and expand the availability of medical devices on the market, should it be reasonably necessary to address significant risks for public health and safety.
According to the Act, the Secretary of State is also responsible for commencing and sustaining the operations of the information systems to be operated by the Health and Social Care Information Centre. Such information systems could be used to keep in a structured way information about:
- The safety and performance, including the clinical effectiveness, of medical devices that are placed on the market;
- The safety of individuals who receive or are treated with a medical device or into whom a medical device is implanted;
- The improvement of medical device safety and performance through advances in technology.
The regulations to be introduced by the Secretary of State could outline the particular scope of information to be entered into the appropriate information system, the use and disclosure of such information, and other related matters. Additionally, such rules can prescribe how the information should be provided, including the persons responsible for the provision of the information, the timeframes for provision of the information, and regulatory procedures associated thereto. The scope of this provision covers any and all entities operating with medical devices.
Under the general rule, the information to be provided for keeping in the information system can include:
- Unique identifiers associated with medical devices;
- Information in relation to individuals conducting operations with medical devices and responsible for providing the appropriate information;
- Information about any procedure carried out in relation to a medical device (including information about any person involved in carrying out the procedure).
With regard to the information contained in the information system, the Information Centre is entitled to analyze it, publish and disclose it in another way in cases prescribed by the applicable legislation.
The Act also prescribes the enforcement actions the regulating authority in the sphere of medical devices may take in order to ensure compliance with the applicable regulatory requirements.
First, the Act describes different types of enforcement notices an authority may issue, namely:
1. Compliance notices. Notices of this type could be issued by the regulating authority when it has reasonable suspicions that the responsible entity fails to comply with certain regulatory requirements related to medical devices. Such notice shall contain information about the medical device in question, grounds for suspicions, the requirement to regain compliance (within the timeline indicated in the notice) and provide evidence demonstrating that compliance has been achieved. The minimal period indicated in the notice should be 28 days from the date the notice was initially provided. Under certain conditions, the regulating authority is allowed to revoke the notice or make changes thereto. If the actions prescribed by the notice should be taken by the medical device manufacturer, the notice could be provided either to the manufacturer directly, or to its authorized representative duly appointed under the applicable regulations.
2. Suspension notices. This type of notices could be issued by the regulating authority when it finds it necessary to suspend further marketing of a medical device due to safety-related concerns. The scope of the notice could cover various activities related to making medical devices available for the patients and healthcare professionals. The notice of this type should contain justification of the decision taken by the authority, and also the indication of the particular period of time the prohibition remains effective (according to the Act, such a period should not exceed 6 months from the date the notice has been issued). The authority is also entitled to either reduce the suspension period or to revoke a notice.
3. Safety notices. This type of notices is used by the authority to impose special prohibitions or requirements reasonably necessary to protect health or safety. For instance, by virtue of a safety notice, the regulating authority may require the responsible person to publish a safety warning related to a medical device or organize a recall of the medical device from the market.
4. Information notice. The regulating authority may issue an information notice requiring the responsible person to provide specified information about the medical device reasonably necessary for the regulating authority to decide on further actions to be taken.
In summary, the Act establishes the basics of regulation in the sphere of medical devices in the UK. The spheres covered by the Act include the powers and responsibilities of the authorities and how the information about medical devices should be collected, kept, and published.
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