PART 4Medical devices
CHAPTER 2Regulations: information systems, advisory committee
19Information systems
1
The Secretary of State may by regulations make provision about the establishment and operation by F4NHS England 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 F5NHS England 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 F5NHS England 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 F6NHS England;
b
about the manner in which, and the time at which, those persons must provide that information;
c
enabling F6NHS England 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 F6NHS England—
i
information of a specified description;
ii
information for specified purposes;
iii
any other information that F6NHS England considers it necessary or expedient to have for the purposes of its functions under the regulations;
d
about any procedural steps F6NHS England 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 F6NHS England 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 F7NHS England 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
c
the disclosure (other than by way of publication) of information F2mentioned in paragraph (b) 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.
F37A
Regulations under this section may provide that the disclosure of information by virtue of this section does not breach—
a
an obligation of confidence owed by the person making the disclosure, or
b
any other restriction on the disclosure of the information (however imposed), other than a restriction imposed by the data protection legislation.
8
In this section, “specified” means specified in regulations under subsection (1).