The In Vitro Diagnostic Medical Devices Regulations 2000

9.  After regulation 19 of the 1994 Regulations there shall be inserted the following regulation—

“Restriction notices

19A.— (1) Where an enforcement authority is of the opinion that it is necessary to restrict the availability of a particular device, or of devices 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.

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

(3) A direction in a restriction notice that has not been withdrawn by an enforcement authority or set aside by an order of a court or a sheriff is a safety provision for the purposes of sections 14 to 17 of the 1987 Act.

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if the court or the sheriff is satisfied that the restriction notice should not have been served or should be withdrawn.

(5) 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 4(a) is an order or decision not to make an order under section 15 of the 1987 Act;

(b) under paragraph 4(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 4(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.”.