Health Products Regulatory Authority (Fees) Regulations 2020.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2020.
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paragraphs: In these Regulations—
(a) means a person established within the European Economic Area who, explicitly designated by the manufacturer, acts for the manufacturer and may be addressed by authorities and bodies in the European Economic Area instead of the manufacturer with respect to the European Communities (Medical Devices) Regulations 1994 ( S.I. No. 252 of 1994 ), the European Communities (Active Implantable Medical Devices) Regulations 1994 ( S.I. No. 253 of 2004 ), or the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 ( S.I. No. 304 of 2001 ),
(b) has the meaning assigned to it by Article 2(32) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 20171 ,
(c) has the meaning assigned to it by Article 2(25) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 20172 ;
(a) a certificate of free sale issued under section 4(1)(k)(ii) (as amended by section 11(a)(iii) of the Act of 2006) of the Act of 1995, or
(b) a certificate of free sale issued under Article 60 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 20173 , or
(c) a certificate of free sale issued under Article 55 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 20174 ;
(a) means—
(i) a person who is responsible for the design, manufacture, packaging and labelling of a medical device before it is placed on the market under his or her own name, regardless of whether these operations are carried out by that person himself or herself or on his or her behalf by a third party, or
(ii) a person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a medical device with a view to their being placed on the market under his or her own name, but not including a person who assembles or adapts medical devices already on the market to their intended purpose for an individual patient, or
(b) has the meaning assigned to it by-
(i) Article 2(30) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 20176 , or
(ii) Article 2(23) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 20177 ;
(a) manufactures a medical device, or
(b) manufactures one or more critical components of a medical device to a set of specifications, or
(c) carries out packaging activities in relation to a medical device, or
(d) carries out labelling activities in relation to a medical device;
(a) means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
(b) or has the meaning assigned to it by Article 2(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 20178 ;
(c) or has the meaning assigned to “device” by Regulation 2 (1) of the European Communities (Medical Devices) Regulations, 1994 (SI 252/1994) which transposed Directive 93/42/EEC of 14th June 1993 into Irish Law
(d) or has the meaning assigned to “device” by Regulation 2 (1) of the European Communities (Active Implantable Medical Devices) Regulations, 1994 (SI 253/1994) which transposed Directive 90/385/EEC of 20th June 1990 into Irish Law
(e) or has the meaning assigned to “device” by Regulation 2 (1) of the European Communities (In Vitro Diagnostic Medical Devices) Regulations, 2001 (S.I. No. 304/2001) which transposed Directive 98/79/EC of the European Parliament and of the Council of 27 October 19989 into Irish law
(f) or has the meaning assigned to it by Article 2(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 201710 ;
(a) means, in relation to any task, a body designated and notified in respect of that task in accordance with the European Communities (Medical Devices) Regulations 1994, the European Communities (Active Implantable Medical Devices) Regulations 1994, or the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001, or
(b) has the meaning assigned to it by Article 2(42) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 201711 , or
(c) has the meaning assigned to it by Article 2(34) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 201712 ;
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paragraphs: Subject to Regulation 4, there shall be paid to the Authority in respect of each and every matter set out in column 1 of the Schedule the corresponding fee set out in column 2 of the Schedule.
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paragraphs: The Authority may, in circumstances where it considers it appropriate to do so, waive, remit or refund, either in whole or in part, any fee that would otherwise be payable to it under Regulation 3.
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paragraphs: The Health Products Regulatory Authority (Fees) Regulations 2019 ( S.I. No. 700 of 2019 ) are revoked.