Medicines and Medical Devices Act 2021

19 Information systems

(1) The Secretary of State may by regulations make provision about the establishment and operation by the Health and Social Care Information Centre (“the Information Centre”) of one or more information systems for purposes relating to—

(a) the safety and performance, including the clinical effectiveness, of medical devices that are placed on the market;

(b) the safety of individuals who receive or are treated with a medical device, or into whom a medical device is implanted;

(c) the improvement of medical device safety and performance through advances in technology.

(2) The regulations may (among other things) make provision—

(a) specifying descriptions of information in relation to medical devices which may or must be entered or retained in an information system established under subsection (1);

(b) requiring information to be provided to the Information Centre for the purposes of its functions under the regulations;

(c) about the use or disclosure of information contained in an information system established under subsection (1);

(d) requiring the Information Centre to have regard to specified matters in exercising its functions under the regulations.

(3) The provision mentioned in subsection (2)(b) may include provision—

(a) requiring specified persons or descriptions of persons to whom subsection (4) applies to provide information of a specified description to the Information Centre;

(b) about the manner in which, and the time at which, those persons must provide that information;

(c) enabling the Information Centre to require specified persons or descriptions of persons to whom subsection (4) applies to provide to it in a manner, and at a time, determined by the Information Centre—

(i) information of a specified description;

(ii) information for specified purposes;

(iii) any other information that the Information Centre considers it necessary or expedient to have for the purposes of its functions under the regulations;

(d) about any procedural steps the Information Centre must follow in requiring a person to provide information to it;

(e) requiring specified persons or descriptions of persons to whom subsection (4) applies to record or retain information which they are, or may be, required to provide to the Information Centre under the regulations;

(f) in relation to the enforcement of any requirement imposed by or under the regulations.

(4) This subsection applies to any person who provides services, or exercises any powers or duties, relating to medical devices.

(5) The descriptions of information specified in the provision mentioned in subsections (2)(a), (3)(a) and (3)(c)(i) may include—

(a) unique identifiers associated with medical devices;

(b) information in relation to individuals mentioned in subsection (1)(b);

(c) information about any procedure carried out in relation to a medical device (including information about any person involved in carrying out the procedure).

(6) The provision mentioned in subsection (2)(c) may include provision about—

(a) the analysis by the Information Centre of information contained in an information system (whether alone or in combination with other information) for the purposes mentioned in subsection (1) or for other purposes;

(b) the publication by the Information Centre of information contained in an information system;

(c) the disclosure (other than by way of publication) of information contained in an information system to specified persons or descriptions of persons, or for specified purposes;

(d) the use or further disclosure by any person of information disclosed to them under the regulations.

(7) The provision mentioned in subsection (3)(f) may include provision applying any provision of Chapter 3 of this Part (enforcement), with or without modifications, in relation to a requirement imposed by or under the regulations.

(8) In this section, “specified” means specified in regulations under subsection (1).