In Vitro Diagnostic Medical Devices (Registration) Regulations 2022.
Statutory Instruments
Source: Statutory Instruments

num: 1
paragraphs: These Regulations may be cited as the In Vitro Diagnostic Medical Devices (Registration) Regulations 2022.
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paragraphs: (1) In these Regulations—
(a) an in vitro diagnostic medical device,
(b) an accessory for an in vitro diagnostic medical device,
(i) a product or other substance excluded by Article 1(3) of the IVD Medical Devices Regulation,
(ii) an in-house device;
(a) is manufactured and used only within a health institution,
(b) complies with all of the conditions in Article 5(5) of the IVD Medical Devices Regulation, and
(c) is not manufactured on an industrial scale;
(a) assigned to it by Article 2(2) of the IVD Medical Devices Regulation, or
(b) assigned to the term “in vitro diagnostic medical device” by Regulation 2(1) of the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 ( S.I. No. 304 of 2001 ),
(a) manufactures a device,
(b) manufactures one or more critical components of a device to a set of specifications,
(c) carries out packaging activities in relation to a device, or
(d) carries out labelling activities in relation to a device;
(2) A word or expression which is used in these Regulations, and which
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paragraphs: (1) This Regulation applies to devices placed on the market in the European Economic Area in accordance with —
(a) the IVD Medical Devices Regulation, and
(b) the Directive pursuant to Article 110(3) of the IVD Medical Devices Regulation.
(2) A manufacturer who, having his or her established place of business
in the State, places a device on the market under his or her own name shall, in the manner prescribed by the Authority—
(a) notify the Authority of his or her name and registered place of business, and
(b) supply the Authority with a description of the device which is sufficient to identify it.
(3) A manufacturer who, having designated an authorised representative which has his or her established place of business in the State, places a device on the market shall, in the manner prescribed by the Authority—
(a) notify the Authority of his or her name and registered place of business,
(b) supply the Authority with a description of the device which is sufficient to identify it, and
(c) furnish the Authority with sufficient evidence to establish that he or she has designated his or her authorised representative in respect of the device concerned in accordance with Article 11 of the IVD Medical Devices Regulation or Article 10(3) of the Directive, as applicable.
(4) An authorised representative having his or her established place of business in the State, shall, in the manner prescribed by the Authority—
(a) notify the Authority of his or her name and registered place of business,
(b) supply the Authority with a description of the device which is sufficient to identify it, and
(c) furnish the Authority with sufficient evidence to establish that he or she has been designated by the manufacturer as his or her authorised representative in respect of the device concerned in accordance with Article 11 of the IVD Medical Devices Regulation or Article 10(3) of the Directive, as applicable.
(5) An importer who, having his or her established place of business in the State, places a device on the market shall, in the manner prescribed by the Authority—
(a) notify the Authority of—
(i) his or her name and registered place of business,
(ii) the name and registered place of business of the manufacturer of the device, and
(b) supply the Authority with information relating to the category of the device.
(6) A distributor who, having his or her established place of business in the State, makes a device available on the market shall, in the manner prescribed by the Authority—
(a) notify the Authority of his or her name and registered place of business, and
(b) supply the Authority with information relating to the category of the device.
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paragraphs: A health institution in the State which manufactures and uses an in-house device within that institution shall, in the manner prescribed by the Authority—
(a) notify the Authority of its name and address, and
(b) supply the Authority with information about the in-house device on request.
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paragraphs: A manufacturing facility in the State shall, in the manner prescribed by the Authority—
(a) notify the Authority in writing of the name and address of the facility, and
(b) supply the Authority with information regarding the activity relating to devices carried out in the facility.