Medical Devices (Registration) Regulations 2021.
Statutory Instruments
Source: Statutory Instruments

num: 1
paragraphs: These Regulations may be cited as the Medical Devices (Registration) Regulations 2021.
num: 2
paragraphs: (1) In these Regulations—
(a) a medical device,
(b) an accessory for a medical device,
(c) a product listed in Annex XVI to the Medical Devices Regulation, provided the Medical Devices Regulation applies to such product pursuant to Article 1(2) thereof,
(d) an in vitro diagnostic medical device, or
(e) an accessory for an in vitro diagnostic medical device, as defined in Article 2(4) of the IVD Medical Devices Regulation,
(i) a product or other substance excluded from the scope of the Medical Devices Regulation by Article 1(6)(b) to (i) thereof,
(ii) a product or other substance excluded from the scope of the IVD Medical Devices Regulation by Article 1(3) thereof,
(iii) a device referred to in the second subparagraph of Article 1(8), (9) or (10) of the Medical Devices Regulation, or
(iv) 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 Medical Devices Regulation, and
(c) is not manufactured on an industrial scale;
(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;
(a) assigned to it by Article 2(1) of the Medical Devices Regulation,
(b) assigned to it by Article 2(2) of IVD Medical Devices Regulation,
(c) assigned to the term “device” by Regulation 2(1) of the European Communities (Medical Devices) Regulations 1994 ( S.I. No. 252 of 1994 ), or
(d) assigned to the term “device” by Regulation 2(1) of the European Communities (Active Implantable Medical Devices) Regulations 1994 ( S.I. No. 253 of 1994 ),
(2) A word or expression which is used in these Regulations, and which is also used in the Medical Devices Regulation, the IVD Medical Devices Regulation, the Medical Devices Directive, or the Active Implantable Medical Devices Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the said Regulation or Directive, as applicable.
num: 3
paragraphs: (1) This Regulation applies to devices, other than custom-made devices, placed on the market in the European Economic Area in accordance with—
(a) the Medical Devices Regulation,
(b) Article 110(5) of the IVD Medical Devices Regulation, or
(c) the Medical Devices Directive or the Active Implantable Devices Directive, as applicable, pursuant to Article 120(3) of the 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 Medical Devices Regulation, Article 11 of the IVD Medical Devices Regulation, Article 14(2) of the Medical Devices Directive or Article 10a(2) of the Active Implantable Medical Devices Directive, as applicable.
(4) An authorised representative 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 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 Medical Devices Regulation, Article 11 of the IVD Medical Devices Regulation, Article 14(2) of the Medical Devices Directive or Article 10a(2) of the Active Implantable Medical Devices Directive, as applicable.
num: 4
paragraphs: (1) This Regulation applies to devices, other than custom-made devices, placed on the market in the European Economic Area in accordance with—
(a) the Medical Devices Regulation, or
(b) the Medical Devices Directive or the Active Implantable Devices Directive, as applicable, pursuant to Article 120(3) of the Medical Devices Regulation.
(2) 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
(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
(iii) the name and registered place of business of the authorised representative designated by the manufacturer of the device, and
(b) supply the Authority with information relating to the category of the device.
(3) A distributor 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 his or her name and registered place of business, and
(b) supply the Authority with information relating to the category of the device.
num: 5
paragraphs: A manufacturer who, having his or her established place of business in the State, places a custom-made device on the market in the European Economic Area, in accordance with Article 52(8) of the Medical Devices Regulation, Article 11(6) of the Medical Devices Directive or Article 9(2) of the Active Implantable Medical Devices Directive, shall, in the manner prescribed by the Authority—
(a) notify the Authority of his or her name and place of business, and
(b) supply the Authority with a description of the device which is sufficient to identify it.
num: 6
paragraphs: Any person who, having his or her established place of business in the State, places a system or procedure pack on the market in the European Economic Area in accordance with Article 22 of the Medical Devices Regulation or Article 12 of the Medical Devices Directive 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 system or procedure pack which is sufficient to identify it.
num: 7
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.
num: 8
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.