The In Vitro Diagnostic Medical Devices Regulations 2000

Notice procedures

19.—(1) Except in the case of a device which in the opinion of an enforcement authority is likely to compromise the health or safety of any person, where an enforcement authority has reasonable grounds for suspecting that a relevant device or a device for performance evaluation is a device in respect of which there is a failure to comply with these Regulations, that authority may serve upon the manufacturer or his authorised representative a notice—

(a) specifying the description of the device to which the notice relates;

(b) stating that the enforcement authority suspects the device is a device in respect of which there is failure to comply with these Regulations and the reasons for that suspicion;

(c) specifying the relevant provision of these Regulations;

(d) requiring the person on whom the notice is served—

(i) to secure that any device to which the notice relates conforms as regards the specified provision within such period as may be specified in the notice, or

(ii) to provide evidence within that period to the satisfaction of the enforcement authority that all the provisions of these Regulations have been complied with so far as they relate to that device; and

(e) warning the person on whom the notice is served that unless the requirements of sub-paragraph (d) are met, further action may be taken under these Regulations or the 1987 Act in respect of that device or any device of the same type supplied by that person.

(2) Where an enforcement authority serves a notice referred to in paragraph (1), section 14, 16 or 17 of the 1987 Act shall not be applied as respects any device to which the notice relates until the period referred to in paragraph (1)(d) has expired and unless, in relation to the alleged failure to comply with these Regulations, at the expiry of that period the person on whom the notice was served has failed to comply with its requirements.

(3) The notice referred to in paragraph (1) may include directions as to the measures to be taken by the person on whom the notice is served to secure compliance with the provisions of these Regulations including different ways of securing compliance, and any such directions as are included are requirements of the notice for the purposes of paragraph (2).

(4) Where an enforcement authority is of the opinion that it is necessary to restrict the availability of—

(a) a particular in vitro diagnostic medical device, a particular accessory to such a device or a particular device for performance evaluation; or

(b) in vitro diagnostic medical devices, accessories to such devices or devices for performance evaluation of a particular class or description,

in order to protect the health or safety of any individual or of individuals of any class or description, they may serve on any person a notice (“a restriction notice”) including such directions restricting the availability of that device or those devices as appear to them to be necessary in order to protect the health or safety of that individual or individuals of that class or description.

(5) The enforcement authority responsible for serving a restriction notice may, in appropriate circumstances, withdraw the notice.

(6) A direction in a restriction notice that has not been withdrawn by an enforcement authority or set aside by an order of a court or a sheriff is a safety provision for the purposes of sections 14 to 17 of the 1987 Act.

(7) Where, in the course of or as a result of enforcement action in relation to a suspected contravention of a direction in a restriction notice, an application has been made to a magistrates' court or a sheriff—

(a) under section 15 of the 1987 Act (appeals against suspension notices), the court or the sheriff may make an order setting aside the restriction notice and any suspension notice served in respect of the suspected contravention of the direction;

(b) under section 16 or 17 of the 1987 Act (which relate to forfeiture of goods), the court or the sheriff may make an order setting aside the restriction notice,

if the court or the sheriff is satisfied that the restriction notice should not have been served or should be withdrawn.

(8) In England, Wales or Northern Ireland, for the purposes of the rights of appeal under section 15(5) and 16(5) of the 1987 Act, an order or decision not to make an order—

(a) under paragraph 7(a) is an order or decision not to make an order under section 15 of the 1987 Act;

(b) under paragraph 7(b) is an order or decision not to make an order under section 16 of the 1987 Act,

and a decision, in Scotland, not to make an order under paragraph 7(b) may, within 21 days of the decision, be appealed to the High Court by Bill of Suspension on the ground of an alleged miscarriage of justice, and the appeal shall be treated in the same way as an appeal under section 17(8) of the 1987 Act.