PART IVIn Vitro Diagnostic Medical Devices
Registration of manufacturers etc. ofin vitro diagnostic medical devices and devices for performance evaluation44
1
Subject to paragraph (3), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person to whom this paragraph applies shall give the Secretary of State the following information—
a
the address of his registered place of business in the United Kingdom;
b
in the case of an authorised representative, sufficient evidence that he is the authorised representative of the manufacturer;
c
in relation to a new relevant device, a statement indicating that the device is a new relevant device, and for the purposes of this regulation a device is a “new relevant device” if—
i
there has been no such device continuously available on the Community market during the previous three years for the relevant analyte or other parameter, or
ii
use of the device involves analytical technology not continuously used in connection with a given analyte or other parameter on the Community market during the previous three years;
d
in relation to a new relevant device, if requested by the Secretary of State (such a request only being permissible within two years from the date on which the Secretary of State was notified that the device was a new relevant device, and on justified grounds), a report relating to the experience gained with the device subsequent to its being placed on the market;
e
if the device wholly or partly consists of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and/or analytes;
f
if the device does not wholly or partly consist of reagents, reagent products or calibration and control materials, the appropriate indications;
g
in relation to devices referred to in a list in Annex II and devices for self-testing—
i
all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I, the outcome of performance evaluation pursuant to Annex VIII, and certificates, and
ii
if requested by the Secretary of State, the labelling and the instructions for use for when the device is placed on the market or put into service within the United Kingdom; and
h
in relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self- testing, all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I,
and shall notify him of any significant change to that information including discontinuation of the placing on the market of the device.
2
Paragraph (1) applies to—
a
a manufacturer with a registered place of business in the United Kingdom who places a relevant device on the market, or who makes available a device for performance evaluation, under his own name; and
b
a person with a registered place of business in the United Kingdom who places a relevant device on the market in the United Kingdom, or who makes available a device for performance evaluation, on behalf of a manufacturer who does not have a registered place of business in the Community or in a State which is a Party to an Association Agreement as his authorised representative.
3
Registration under this regulation is not required if—
a
the device was first placed on the market in another Member State of the Community or in a State which is a Party to an Association Agreement (if that Agreement contains measures relating to the mutual recognition of the results of conformity assessment undertaken in respect of that device); and
b
the manufacturer or his authorised representative has already registered with the competent authorities of that other State.