S.I. No. 256/2022 - In Vitro Diagnostic Medical Devices Regulations 2022

• (6) Where material to which a production order relates consists of information stored electronically, the order shall have effect as an order to produce the material, or to give access to it, in a form in which it is visible and legible and in which it can be taken away.

• (7) A production order —

• (a) in so far as it may empower an authorised officer to take away a document or to be given access to it, shall authorise him or her to make a copy of it and to take the copy away,

• (b) shall not confer any right to production of, or access to, any material subject to legal privilege, and

• (c) shall have effect notwithstanding any other obligation as to secrecy or other restriction on disclosure of information imposed by statute or otherwise.

• (8) Any material taken away by an authorised officer under this Regulation may be retained by him or her for use as evidence in any proceedings.

• (9) A judge of the District Court may vary or discharge an order under this Regulation on the application of any person to whom an order under this Regulation relates or an authorised officer.

Quarantine notice

29.

• (a) there is a potential non-compliance with a requirement of the EU Regulation or these Regulations in relation to a device or other relevant thing or relevant service, or

• (b) a device or other relevant thing or relevant service has the potential to pose a serious risk to human health,

the authorised officer may, with the approval of the chief executive of the Authority, or another officer of the Authority designated by the chief executive of the Authority for that purpose, serve, or arrange to have served, on the manufacturer, authorised representative, distributor, health institution, economic operator, notified body or other person(s) concerned a notice (“quarantine notice”) in accordance with paragraph (2).

• (2) A quarantine notice shall—

• (a) be signed by the authorised officer issuing it, or the officer consulted in accordance with paragraph (1),

• (b) state the reason why quarantine is being applied or provide a justification for the quarantine action,

• (c) specify—

• (i) the provision or provisions of the EU Regulation or these Regulations with which there is non-compliance and the matters giving rise to the non-compliance, or

• (ii) the serious risk to human health posed by the device or relevant thing or relevant service, and

• (iii) direct the person on whom the quarantine notice is served to ensure that the device or relevant thing or relevant service is not to be placed on the market, made available on the market, put into service or offered by means of information society services until all the necessary conditions for the device, relevant thing or relevant service to be compliant have been met or the device, relevant thing or relevant service no longer poses a serious risk to human health, as appropriate.

• (3) The approval referred to in paragraph (1) may be given orally or in writing and if given orally shall be recorded in writing as soon as practicable.

• (4) Save in the case of a quarantine notice which takes effect immediately when it is received by the person on whom it is served, a quarantine notice shall give the person on whom it is served a reasonable period within which he, she or it may put forward his, her or its viewpoint on the notice or appeal the notice.

• (5) Where appropriate, the Authority shall, without delay, provide a copy of the quarantine notice to the person(s) responsible for regulatory compliance of the manufacturer, the authorised representative, the person responsible in the health institution in respect of the in-house device concerned or the person responsible for the relevant thing or relevant service concerned, and where necessary any importer(s) or distributor(s).

• (6) Subject to paragraph (7)(a), a quarantine notice shall give the person on whom it is served a reasonable period within which he or she may put forward his or her viewpoint on the notice or appeal the notice.

• (7) A quarantine notice shall take effect—

• (a) where required, and where the quarantine notice so declares, immediately when the notice is received by the person on whom it is served, or

• (b) in any other case—

• (i) where no appeal is taken against the quarantine notice, on expiration of the period referred to in paragraph (6), or

• (ii) where an appeal is taken, on the day next following the day on which the quarantine notice is confirmed on appeal or the appeal is withdrawn or on the expiration of the period referred to in paragraph (6), whichever is the later.

• (8) The chief executive of the Authority, or another officer of the Authority designated by the chief executive of the Authority for that purpose, may, for stated reasons, revoke or vary a quarantine notice issued by an authorised officer appointed by the Authority.

• (9) In the event of non-compliance by the person on whom a quarantine notice has been served, an authorised officer, other than an authorised officer who is an officer of Customs and Excise, shall, with the approval of the chief executive of the Authority, or another officer thereof designated by the chief executive of the Authority for that purpose, take whatever measures are considered necessary to ensure compliance with the quarantine notice, including the seizure, detention and destruction of the device in question or the making of any arrangements for such seizure, detention and destruction or the required cessation of the service.

• (10) This Regulation shall not operate to prevent or restrict—

• (a) the entitlement of the Authority to take other action to secure compliance with the EU legislation and these Regulations by a person, or

• (b) the bringing or prosecuting of any proceedings for an offence under these Regulations.

Compliance notice

30.

• (2) A compliance notice shall—

• (a) be signed by the authorised officer issuing it, or the officer consulted in accordance with paragraph (1),

• (b) identify the requirement(s) of the EU Regulation or these Regulations with which there has not been compliance,

• (c) identify the corrective actions to be taken,

• (d) where appropriate, direct the person on whom the compliance notice is served to inform, without delay, the manufacturer, authorised representative, distributor(s) or importer(s) of the device concerned, the health institution of the in-house device concerned or the person responsible for the relevant thing or relevant service concerned of the corrective actions to be taken, and

• (e) give a time period, commensurate with the nature of the risk, within which the person on whom the compliance notice is served must take the corrective actions identified pursuant to subparagraph (c).

• (3) Where appropriate, the authorised officer shall, without delay, provide a copy of the compliance notice to the person(s) responsible for regulatory compliance of the manufacturer, the authorised representative, the person responsible in the health institution in respect of the in-house device concerned or the person responsible for the relevant thing or relevant service concerned, and where necessary any importer(s) or distributor(s).

• (4) Subject to paragraph (5)(a), a compliance notice shall give the person on whom it is served a reasonable period within which he, she or it may put forward his, her or its viewpoint on the notice or appeal the notice.

• (5) A compliance notice shall take effect—

• (a) where required, and where the compliance notice so declares, immediately when the notice is received by the person on whom it is served, or

• (b) in any other case—

• (i) where no appeal is taken, on expiration of the period referred to in paragraph (4), or

• (ii) where an appeal is taken, on the next day following the day on which the notice is confirmed on appeal or the appeal is withdrawn or on the expiration of the period referred to in paragraph (4), whichever is the later.

• (6) The chief executive of the Authority or another officer of the Authority designated by the chief executive of the Authority for that purpose may, for stated reasons, revoke or vary a compliance notice issued by an authorised officer appointed by the chief executive of the Authority.

• (7) In the event of non-compliance with a compliance notice by the person on whom a compliance notice has been served, an authorised officer shall, with the approval of the chief executive of the Authority, or another officer thereof designated by the chief executive of the Authority for that purpose, take whatever measures are considered necessary to ensure compliance with the compliance notice, including the seizure, detention and destruction of the relevant thing or device in question or the required cessation of the relevant service or the making of any arrangements for such seizure, detention, destruction or required cessation.

• (8) This Regulation shall not operate to prevent or restrict—

• (a) the entitlement of the Authority to take other action to secure compliance with the EU Regulation and these Regulations by a person, or

• (b) the bringing or prosecuting of any proceedings for an offence under these Regulations.

Prohibition order

31.

• (a) there is non-compliance with a requirement of the EU Regulation or these Regulations,

• (b) a device, other relevant thing or relevant service presents an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, or

• (c) a person has failed to comply with a compliance notice,

the Authority may serve, or arrange to have served, on the person concerned an order (“prohibition order”) in accordance with paragraph (2).

• (2) A prohibition order shall—

• (a) be signed by the chief executive officer of the authority or another officer thereof authorised for that purpose by the chief executive officer,

• (b) state that the Authority is of the opinion that a particular consignment, group, category, batch or lot of the device, relevant thing or relevant service concerned is not in conformity with the EU Regulation or these Regulations,

• (c) specify the provision or provisions of the EU Regulation or these Regulations with which the device, relevant thing or relevant service is not in compliance and the matters giving rise to the non-compliance,

• (d) where relevant, identify the part or parts of the compliance notice with which there has not been compliance, and

• (e) direct the person on whom the prohibition order is served to ensure that—

• (i) the device, relevant thing or relevant service is not to be placed on the market, made available on the market, put into service or offered by means of information society services until such time as all appropriate measures, including corrective measures, have been taken to bring the device, relevant thing or relevant service into conformity with the EU Regulation or these Regulations,

• (ii) the placing on the market, making available on the market or putting into service of the device or relevant thing or the offering of a relevant service by means of information society services is restricted or made subject to particular requirements,

• (iii) the device or relevant thing is prohibited from being placed on the market, made available on the market or put into service,

• (iv) the relevant service is prohibited from being offered,

• (v) the device or relevant thing is withdrawn or recalled from the market within a specified time-limit,

• (vi) the relevant service is withdrawn from the market within a specified time-limit,

• (vii) the device or relevant thing is destroyed within a specific time limit and in a manner prescribed by the Authority or is detained for the purposes of destruction by an authorised officer, or

• (viii) the relevant service is ceased within a specific time limit and in a manner prescribed by the Authority.

• (3) The approval referred to in paragraph (1) may be given orally or in writing and if given orally shall be recorded in writing as soon as practicable.

• (4) Where appropriate, the Authority shall, without delay, provide a copy of the prohibition order to the person(s) responsible for regulatory compliance of the manufacturer, the authorised representative, the person responsible in the health institution in respect of the in-house device concerned or the person responsible for the relevant thing or relevant service concerned, and where necessary any importer(s) or distributor(s).

• (5) A prohibition order shall take effect—

• (a) where the prohibition order so declares, immediately when the order is received by the person on whom it is served, or

• (b) in any other case—

• (i) where no appeal is taken against the prohibition order, on the expiration of the period during which such an appeal may be taken or the day specified in the prohibition order as the day on which it is to come into effect, whichever is the later, or

• (ii) where an appeal is taken, on the next day following the day on which the prohibition order is confirmed on appeal or the appeal is withdrawn or the day specified in the prohibition order as the day on which it is to come into effect, whichever is the later.

• (6) The bringing of an appeal against a prohibition order which is to take effect in accordance with paragraph (5)(a) shall not have the effect of suspending the operation of the prohibition order, but the appellant may apply to the Circuit Court to have the operation of the prohibition order suspended until the appeal is disposed of and, on such application, the Circuit Court may, if it thinks it proper to do so, direct that the operation of the prohibition order be suspended until the appeal is disposed of.

• (7) In the event of non-compliance by the person on whom the prohibition order has been served, an authorised officer shall, with the approval of the chief executive of the Authority or other officer designated in that behalf by the chief executive of the Authority, take whatever steps are considered necessary to ensure compliance with the direction given under paragraph (2)(e) and this may include the seizure, detention and destruction of the devices or relevant things or the required cessation of relevant services in question or the making of any arrangements for such seizure, detention, destruction or required cessation.

• (8) This Regulation shall not operate to prevent or restrict—

• (a) the entitlement of the Authority to take other action to secure compliance with the EU Regulation and these Regulations by a person, or

• (b) the bringing or prosecuting of any proceedings for an offence under these Regulations.

• (9) The chief executive of the Authority may, for stated reasons, revoke or vary a prohibition order made in accordance with this Regulation and the Authority shall be notified at the next available meeting of the Authority of any such revocation or variation and the reasons therefore.

• (10) Where a prohibition order has been served and activities are carried on in contravention of the prohibition order, the High Court may, on the application of the Authority, by order prohibit the continuance of the activities.

• (11) An application to the High Court for an order under paragraph (10) shall be by motion and the Court, when considering the matter, may make such interim or interlocutory order (if any) as it considers appropriate and the order by which an application under paragraph (10) is determined may contain such terms and conditions (if any) as to the payment of costs as the Court considers appropriate.

Appeals from quarantine notices and compliance notices

32.

• (2) The Authority shall inform a person of his or her right of appeal, and the applicable time limits, when serving him, her or it with a quarantine notice or compliance notice.

• (3) A person who is aggrieved by a decision on an appeal under paragraph (1) may appeal that decision to the District Court in the district court district in which the quarantine notice or compliance notice was served, not later than 7 days after the decision concerned.

• (4) The bringing of an appeal under this Regulation against a notice which is to take effect immediately on service shall not have the effect of suspending the operation of the notice, but the appellant may apply—

• (a) in the case of an appeal under paragraph (1), in accordance with the procedures referred to therein, or

• (b) in the case of an appeal under paragraph (3), to the District Court, to have the operation of the quarantine notice or compliance notice concerned suspended until the appeal is disposed of.

• (5) The District Court shall, upon an appeal under paragraph (3), do one of the following:

• (a) affirm the notice concerned;

• (b) direct the Authority to withdraw the notice concerned; or

• (c) direct the Authority to modify the notice concerned.

• (6) The Authority shall comply with a direction under paragraph (5)(b) or (c).

• (7) Where on the hearing of an appeal under paragraph (3) a notice is affirmed, notwithstanding Regulation 29(7) or 30(5), as applicable, the judge of the District Court by whom the appeal is heard may, on the application of the appellant, suspend the operation of the notice for such period as in the circumstances of the case the district judge considers appropriate.

• (8) A person who appeals under paragraph (3) or who applies for a direction under paragraph (7) shall at the same time notify the Authority of the appeal or application and the grounds for the appeal or application and the Authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal or application.

• (9) A decision of the District Court on an appeal under paragraph (3) shall be final.

Appeals from prohibition orders

33.

• (2) The bringing of an appeal under this Regulation against a prohibition which is to take effect immediately on service shall not have the effect of suspending the operation of the order, but the appellant may apply to the Circuit Court to have the operation of the order suspended until the appeal is disposed of and, on such application, the Court may, if it thinks it proper to do so, direct that the operation of the order be suspended until the appeal is disposed of.

• (3) The Circuit Court shall, upon an appeal under this Regulation, do one of the following:

• (a) affirm the order concerned;

• (b) direct the Authority to withdraw the order concerned; or

• (c) direct the Authority to modify the order concerned.

• (4) The Authority shall comply with a direction under paragraph (3)(b) or (c).

• (5) Where on the hearing of an appeal under this Regulation an order is affirmed, notwithstanding paragraph Regulation 31(5), as applicable, the judge of the Circuit Court by whom the appeal is heard may, on the application of the appellant, suspend the operation of the order for such period as in the circumstances of the case the judge considers appropriate.

• (6) A person who appeals under this Regulation or who applies for a direction under paragraph (5) shall at the same time notify the Authority of the appeal or application and the grounds for the appeal or application and the Authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal or application.

• (7) A decision of the Circuit Court on an appeal under this Regulation shall be final, save

that, by leave of the Court an appeal from the decision shall lie to the High Court on a specified question of law.

Destruction and disposal

34.

• (a) any relevant thing, book, record, document, or premises is detained under this Part, but is not the subject of a prosecution, and

• (i) no claim is made for its return within 28 days of notice in writing being given of the intention to destroy or dispose of same, or render same inoperable, or

• (ii) the supplier of the relevant thing is not reasonably identifiable, or

• (b) a device being supplied at a distance by information society services in contravention of the EU Regulation is detained,

an authorised officer may destroy or dispose of, or render inoperable, such thing, book, record, document, premises or device, in the interest of the protection of public health.

Suspension, restriction and withdrawal of designation of notified bodies

35.

• (a) no longer meets the applicable requirements set out in the EU Regulation,

• (b) is failing to fulfil its obligations, or

• (c) has not implemented necessary corrective measures,

the Authority shall suspend, restrict or fully or partially withdraw the notified body’s designation, in accordance with Article 42(4) of the EU Regulation.

Service of notices and orders

36.

• (a) by addressing it to the person by name and delivering it to him or her;

• (b) by leaving it at the address at which the person ordinarily resides or carries on business;

• (c) by sending it by post in a prepaid registered letter addressed to the person at the address at which he or she ordinarily resides or carries on business;

• (d) if an address for the service of notices has been furnished by the person, by leaving it at, or sending it by prepaid registered post addressed to him or her to, that address;

• (e) where the address at which the person ordinarily resides or carries on business cannot be ascertained by reasonable inquiry and notice is required to be served on, or given to, him or her in respect of any premises by delivering it to a person over the age of 16 years resident in or employed on the premises, or by affixing it in a conspicuous position on or near the premises; or

• (f) by sending it by means of electronic mail to a facility for the reception of electronic mail where such an electronic mail address has been furnished by the person, but only if the sender’s facility for the reception of electronic mail generates a message confirming a receipt of the electronic mail confirming successful transmission of the notice.

• (2) Where the name of the person concerned cannot be ascertained by reasonable inquiry, a notice or order under this Part may be addressed to “the occupier”, “the owner” or “the person in charge”, as the case may be.

• (3) For the purposes of this Regulation, a company within the meaning of the Companies Act 2014 (No. 38 of 2014) shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or place of business.

• (4) A person shall not at any time during the period of 3 months after a notice is affixed under paragraph (1)(e) remove, damage or deface the notice without lawful authority.

PART 6 REVOCATIONS AND TRANSITIONAL PROVISIONS

Revocations

37.

• (a) the Regulations of 2001;

• (b) the European Communities (Medical Devices) (Amendment) Regulations 2002 ( S.I. No. 576 of 2002 ), other than Regulation 3 thereof;

• (c) the European Communities (In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2012 ( S.I. No. 207 of 2012 );

• (d) the European Communities (In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2020 ( S.I. No. 145 of 2020 );

• (e) the European Communities (In Vitro Diagnostic Medical Devices) (Amendment)(No. 2) Regulations 2020 ( S.I. No. 302 of 2020 ).

Transitional provisions

38.

• (a) a person is not guilty of an offence by reason of relying upon a certificate issued by a notified body in accordance with the Directive (other than a certificate issued in accordance with Annex VI to the Directive) prior to 25 May 2017 provided that the period indicated on the certificate has not expired,

• (b) until 27 May 2025, a person is not guilty of an offence by reason of relying upon a certificate issued by a notified body in accordance with Annex VI to the Directive prior to 25 May 2017 provided that the period indicated on the certificate has not expired,

• (c) until 27 May 2025, a person is not guilty of an offence by reason of relying upon a certificate issued by a notified body in accordance with the Directive on or after 25 May 2017 provided that the period indicated on the certificate has not expired,

• (d) a person is not guilty of an offence by reason of placing on the market or putting into service, on or before 26 May 2025, a class D device for which the conformity assessment procedure pursuant to the Directive did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 and for which the conformity assessment procedure pursuant to the EU Regulation requires the involvement of a notified body or any device which has a certificate that was issued in accordance with the Directive and that is valid by virtue of Article 110(2) of the EU Regulation, provided that—

• (i) from 26 May 2022 the device continues to comply with the Directive,

• (ii) there are no significant changes in the design and intended purpose of the device, and

• (iii) the requirements of the EU Regulation relating to post- market surveillance, market surveillance, vigilance, registration of economic operators and of devices are complied with in place of the corresponding requirements in the Directive,

• (e) a person is not guilty of an offence by reason of placing on the market or putting into service, on or before 26 May 2026, a class C device for which the conformity assessment procedure pursuant to the Directive did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 and for which the conformity assessment procedure pursuant to the EU Regulation requires the involvement of a notified body, provided that—

• (i) from 26 May 2022 the device continues to comply with the Directive,

• (ii) there are no significant changes in the design and intended purpose of the device, and

• (iii) the requirements of the EU Regulation relating to post- market surveillance, market surveillance, vigilance, registration of economic operators and of devices are complied with in place of the corresponding requirements in the Directive,

• (f) a person is not guilty of an offence by reason of placing on the market or putting into service, on or before 26 May 2027, a class B device or a class A device placed on the market in sterile condition, for which the conformity assessment procedure pursuant to the Directive did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 and for which the conformity assessment procedure pursuant to the EU Regulation requires the involvement of a notified body, provided that—

• (i) from 26 May 2022 the device continues to comply with the Directive,

• (ii) there are no significant changes in the design and intended purpose of the device, and

• (iii) the requirements of the EU Regulation relating to post- market surveillance, market surveillance, vigilance, registration of economic operators and of devices are complied with in place of the corresponding requirements in the Directive,

• (g) until 26 May 2025, a person is not guilty of an offence by reason of making available on the market or putting into service a device lawfully placed on the market pursuant to the Directive prior to 26 May 2022,

• (h) a person is not guilty of an offence by reason of making available on the market or putting into service a device lawfully placed on the market from 26 May 2022 pursuant to Article 110 of the EU Regulation,

• (i) until 26 May 2026, for devices referred to in the second subparagraph or in the third subparagraph, point (a) of paragraph 3 of that Article;

• (ii) until 26 May 2027, for devices referred to in the third subparagraph, point (b) of paragraph 3 of that Article;

• (iii) until 26 May 2028, for devices referred to in the third subparagraph, points (c) and (d) of paragraph 3 of that Article,

• (i) A sponsor is not guilty of an offence by reason of the continuance of a performance evaluation which was commenced in accordance with Article 9(4) and 10(1) of the Directive before 26 May 2022, provided that the reporting of serious adverse events and device deficiencies is carried out in accordance with the EU Regulation,

• (j) Notwithstanding subparagraphs (d)(i), (e)(i) and (f)(i) of paragraph (1) of this Regulation, a person is not guilty of an offence if they comply with Article 26(3), Article 28(1) and Article 51(5) of the EU Regulation rather than Article 10 and points (a) and (b) of Article 12(1) and Article 15(5) of the Directive as specified in Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices,¹⁰ during the period starting on the later of the dates referred to in point (f) of Article 113(3) and ending 18 months later.

• (2) Notwithstanding Regulation 37, until six months after the Eudamed functionality date, Regulation 7 and 23 (inserted by Regulation 2 of the European Communities (In Vitro Diagnostic Medical Devices) (Amendment) (No. 2) Regulations 2020) of the Regulations of 2001, continue to apply as if they had not been revoked, for the purposes of information and data exchange only, and a person who fails to comply with same is guilty of an offence.

• (3) Notwithstanding Regulation 37 —

• (a) Regulations 7(5) and 10(1)(b)(ii) of the Regulations of 2001 shall continue to apply, as if they had not been revoked, in respect of performance evaluations which were commenced in accordance with Articles 9(4) and 10(1) of the Directive and Regulation 7(5) of the Regulations of 2001 before 26 May 2022, and

• (b) a device which has been authorised by the Authority in accordance with Regulation 8(11) of the Regulations of 2001 shall keep the validity indicated in the authorisation.

• (4) Notwithstanding Regulation 37, Regulation 11(4), (5) and (6) of the Regulations of 2001 continue to apply, as if they had not been revoked, in respect of—

• (i) devices granted CE Marking approval thereunder and made available on the market or put into service , and

• (ii) the means by which information is to be exchanged with and notifications to the Authority,up until six months after the Eudamed functionality date.

• (5) Notwithstanding Regulation 37, as regards the devices referred to in subparagraphs

• (d) to (h) of paragraph (1), the Regulations of 2001, continue to apply until the associated timelines set out therein to the extent necessary for the application of Articles 110(3) and (4) of the EU Regulation, as if the Regulations of 2001 had not been revoked.

• (6) Notwithstanding the provisions of these Regulations, until 6 months after the Eudamed functionality date, the offences in—

• (a) Regulation 14(1)(m), (y), (aa), (bb), (cc), (dd), (ee), (ff), (gg) and (jj),

• (b) Regulation 15(e) and (f),

• (c) Regulation 17(j),

• (d) Regulation 18(c) and (d),

• (e) Regulation 21(2)(l), (m), (n), (o), (p), (q) and (r),

• (f) Regulation 21(6)(a) and (d),

do not apply, but only insofar as they apply to the obligations and requirements that relate to Eudamed, including using Eudamed as the mechanism for information exchange.

• (7) Notwithstanding the provisions of these Regulations, until 24 months after the Eudamed functionality date, the offence in Regulation 17(k) does not apply.

• (8) Notwithstanding the provisions of these Regulations, until 24 months after the Eudamed functionality date, the offences in Regulation 19(u) and (x) do not apply, but only insofar as they apply to the obligations and requirements that relate to Eudamed, including using Eudamed as the mechanism for information exchange.

• (9) Notwithstanding the provisions of these Regulations—

• (a) until 26 May 2023, for Class D devices, and

• (b) until 26 May 2025, for Class B and C devices, and

• (c) until 26 May 2027, for class A devices, the offence in Regulations 14(w) does not apply.

• (10) Notwithstanding the provisions of these Regulations —

• (a) until May 2024, the offence in Regulation 20(b) does not apply insofar as it relates to Article 5(5), (b) (c) and (e) to (i) of the EU Regulations,

• (b) until May 2028, the offence in Regulation 20(b) does not apply insofar as it relates to Article 5(5)(d) of the EU Regulation.

• (11) In this Regulation –

“Eudamed functionality date” means the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017¹¹ , as amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020¹² .

GIVEN under my Official Seal,

25 May, 2022.

STEPHEN DONNELLY,

Minister for Health.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations—

• confer functions on the Health Products Regulatory Authority in relation to in vitro diagnostic medical devices,

• set out certain requirements which apply where a genetic test is used on individuals in the context of healthcare,

• provide for various matters in relation to performance studies of in vitro diagnostic medical devices, and

• provide offences for breaches of the requirements of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, as amended by Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 and provisions herein.

Footnotes