6Kind of information—IVD medical devices

6 Kind of information—IVD medical devices

Class 1 IVD medical devices (1A) An application for a Class 1 IVD medical device must be accompanied by the following kind of information: (a) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 1A of Schedule 2, which is recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document in relation to the medical device specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item. (1B) To avoid doubt, a document which accompanies the application in accordance with subsection (1A) must relate to the kind of device to which the application relates. Class 2 IVD medical devices (1) An application for a Class 2 IVD medical device must be accompanied by the following kind of information: (a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 1 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item; and (c) if the application is accompanied by the information specified in item 2 or 2B in the table in Part 1 of Schedule 2—evidence to demonstrate compliance with Article 110(3c) of the EU IVD regulation. (2) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (1)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (1)(b) (if any); (b) a document which accompanies the application in accordance with subsection (1) must relate to the kind of device to which the application relates. Class 3 IVD medical devices (3) An application for a Class 3 IVD medical device must be accompanied by the following kind of information: (a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 2 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item; and (c) if the application is accompanied by the information specified in item 3, 3B or 4 in the table in Part 2 of Schedule 2—evidence to demonstrate compliance with Article 110(3c) of the EU IVD regulation. (4) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (3)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (3)(b) (if any); (b) a document which accompanies the application in accordance with subsection (3) must relate to the kind of device to which the application relates. Class 4 IVD medical devices (5) An application for a Class 4 IVD medical device must be accompanied by the following kind of information: (a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 3 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item; and (c) if the application is accompanied by the information specified in item 3 or 4 in the table in Part 3 of Schedule 2—evidence to demonstrate compliance with Article 110(3c) of the EU IVD regulation. (6) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (5)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (5)(b) (if any); (b) a document which accompanies the application in accordance with subsection (5) must relate to the kind of device to which the application relates. Class 4 in-house IVD medical devices (7) An application for a Class 4 in-house IVD medical device must be accompanied by the following kind of information: (a) a conformity assessment document or other evidence that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 4 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item. (8) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (7)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (7)(b) (if any); (b) a document which accompanies the application in accordance with subsection (7) must relate to the kind of device to which the application relates.