HPRA · structured requirements

🇮🇪 Ireland medical device regulatory data

Explore the medical device requirements currently available for Ireland, organized by topic and linked to official sources.

39 facts23 dimensions15 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Misleading claims prohibition (Art. 7)

advertising.misleading-claims-art-7

Fact-level verified

In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: ascribing functions and properties to the device which the device does not have; creating a false impression regarding treatment or diagnosis; failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose; or suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Conditions

EU-wide rule under Regulation (EU) 2017/745, which applies directly in the member state; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Annual maintenance fee cycle for registered operators

renewal.annual-maintenance-fee-cycle

Fact-level verified

National device registration carries an annual maintenance fee for all registered economic operators (whether registered via EUDAMED or directly with HPRA), invoiced in quarter 2 of each year; amounts vary by role and organisation size.

Conditions

Entities registering directly with HPRA additionally pay the one-off administration fee (code 431).

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority

authority.competent-authority

Fact-level verified

The Health Products Regulatory Authority (HPRA) is Ireland's competent authority for medical devices: S.I. No. 261 of 2021 defines 'Authority' as the HPRA and assigns it the State functions under the listed MDR articles (including Articles 42, 70-78, 95, 96, 98, 100, 102, 106, 109 and 110).

Conditions

Applies to medical devices; parallel assignment of IVDR State functions to HPRA in S.I. No. 256 of 2022 reg. 4(1).

Effective from 2021-05-26

Upgrades the baseline fact (previously sourced to the Commission's CA-contacts page) to the national statute.

Enforcement mandate

authority.enforcement-mandate

Fact-level verified

The Medical Devices Regulations 2021 and the MDR provisions they refer to are enforced by HPRA.

Conditions

Medical devices; enforcement tools include quarantine notices, compliance notices and prohibition orders (S.I. 261/2021 regs. 31-33).

Effective from 2021-05-26

Market surveillance authority

authority.market-surveillance-authority

Fact-level verified

HPRA is designated as the market surveillance authority for medical devices for the purposes of Regulation (EC) No 765/2008 and the Market Surveillance Regulation (EU) 2019/1020.

Conditions

Medical devices designated under S.I. 261/2021 reg. 4(2); parallel designation for IVDs in S.I. 256 of 2022 reg. 4(2).

Effective from 2021-05-26

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Substantial modification of a clinical investigation

change.ci-substantial-modification

Fact-level verified

Substantial modifications to an ongoing clinical investigation must be notified to HPRA for assessment before implementation (Notification of Substantial Modification form, submitted via the CESP steps); refusal of a substantial-modification authorisation is appealable under S.I. 261 of 2021 reg. 15(1)(c).

Conditions

Whether a modification is substantial is judged per MDCG 2021-6; unsure sponsors can ask devices@hpra.ie.

Substantial modification of a performance study

change.ps-substantial-modification

Fact-level verified

Substantial modifications to HPRA-approved IVD performance studies are notified per IVDR Article 71 via CESP using the Appendix 2 format of AUT-G0176-2 (description, justification, impact, affected documents); a positive research ethics committee opinion may also be required before implementation.

Conditions

Channel applies until the relevant EUDAMED functionality is established.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Article 62 investigation cannot start before HPRA authorisation

clinical.art62-start-restriction

Fact-level verified

A sponsor must not start a clinical investigation of the Article 62 type in Ireland until HPRA has notified the sponsor of its authorisation within the period referred to in MDR Article 70(7)(b).

Conditions

Article 62 covers generally non-CE-marked devices or CE-marked devices used outside their intended purpose.

Effective from 2021-05-26

NREC-MD ethics approval required

clinical.nrec-md-ethics-required

Fact-level verified

All clinical investigations in Ireland must receive ethics approval from the National Research Ethics Committee for Medical Devices (NREC-MD) before starting; the NREC-MD review is independent of the HPRA review and a copy of the opinion goes to HPRA (S.I. 261 of 2021 reg. 11).

Conditions

Sponsors may apply to NREC-MD and HPRA in parallel; the investigation cannot start until both reviews are complete.

30-day prior notification for other clinical investigations

clinical.other-ci-30-day-notification

Fact-level verified

For clinical investigations outside Articles 62 and 74 (Article 82 type), the sponsor must notify HPRA in writing at least 30 days before commencement; HPRA confirms the investigation may start at least 30 calendar days after notification, provided NREC-MD ethical approval is also in place.

Conditions

Article 82 investigations must additionally comply with Part 3, Article 14 of S.I. 261 of 2021.

Effective from 2021-05-26

HPRA guidance (AUT-G0095-7 section 5) states the same 30-calendar-day start rule for Article 74/82 notifications.

Performance study application and notification categories

clinical.ps-application-ivdr

Fact-level verified

IVDR Article 58(1) performance studies (surgically invasive sample-taking only for the study, interventional clinical performance studies, additional invasive procedures or risks, or companion diagnostics) require HPRA application and authorisation for all IVD classes A-D; Article 58(2) companion-diagnostic leftover-sample studies and Article 70(1) in-intended-purpose studies with additional invasive/burdensome procedures require notification (Article 70(1): at least 30 days before commencement); Article 70(2) studies require the full Article 58-77 application.

Conditions

A study is 'conducted in Ireland' where the site is in Ireland or participants/specimens originate from Ireland.

Effective from 2022-05-26

Safety reporting and end-of-study duties

clinical.study-safety-reporting

Fact-level verified

During medical-device clinical investigations, SAEs and device deficiencies are reported to HPRA at devices@hpra.ie using MDCG 2020-10 forms; for IVD performance studies, reports go to devicesafety@hpra.ie until EUDAMED PS modules are functional. Safety-ground halts/terminations must be notified within 24 hours, other endings within 15 days; the end-of-study report is due within one year (three months if halted or terminated early).

Conditions

Performance-study reporting applies to all studies conducted in Ireland including pre-IVDR studies, except Article 70(1) studies where vigilance reporting applies.

IVD channel per AUT-G0176-2 section 7.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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IVD registration scope excludes in-house devices

scope.ivd-registration-excludes-in-house

Fact-level verified

For Irish national IVD registration, 'device' means an in vitro diagnostic medical device or IVD accessory and expressly excludes in-house devices and products excluded by IVDR Article 1(3); health institutions manufacturing and using in-house IVDs are notified separately under reg. 4.

Conditions

Applies to the national registration regime of S.I. 365 of 2022, not to the EU-level IVDR device definition.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Technical documentation (Annexes II and III)

dossier.technical-documentation-annex-ii

Fact-level verified

The technical documentation required to demonstrate conformity with the general safety and performance requirements must be drawn up in accordance with Annex II to Regulation (EU) 2017/745 (device description and general information, information supplied by the manufacturer, information on design and manufacture, general safety and performance requirements, benefit-risk analysis and risk management, product verification and validation) together with the post-market surveillance technical documentation of Annex III, and kept available to the competent authorities.

Conditions

EU-wide rule under Regulation (EU) 2017/745, which applies directly in the member state; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Authorised representative designation evidence

roles.ar-designation-evidence

Fact-level verified

An authorised representative established in Ireland must, when registering with HPRA, furnish sufficient evidence that it has been designated by the manufacturer for the device concerned (in addition to organisation and device details).

Conditions

IVD rule quoted verbatim; medical-device parallel in S.I. 691 of 2021 reg. 3(4).

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Distributor registration (medical devices)

establishment.distributor-notification-md

Fact-level verified

Distributors established in Ireland who place medical devices (other than IVDs) on the market must notify HPRA of their name, registered place of business and the device category — a national registration duty going beyond MDR distributor obligations.

Conditions

Applies to devices other than IVD devices under S.I. 691 of 2021 reg. 4; IVD distributors covered by S.I. 365 of 2022 reg. 3(6).

Manufacturing facility notification

establishment.manufacturing-facility-notification

Fact-level verified

'Manufacturing facilities' in Ireland — entities that do not place devices on the market under their own name but manufacture devices or critical components, or carry out packaging or labelling activities — must notify HPRA in writing of the facility name and address and supply information on the device-related activity.

Conditions

Definition in S.I. 691 of 2021 reg. 2(1); IVD equivalent in S.I. 365 of 2022 reg. 5 with 'manufacturing facility' defined in its reg. 2(1).

Fees

What regulator fee applies to this class, route, event, and date?

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No registration admin fee when registering directly on EUDAMED

fees.exemption-eudamed-direct-registration

Fact-level verified

The one-off national registration administration fee (fee code 431, EUR 150) is not charged where the economic operator registers directly on EUDAMED; all entities established in Ireland under the MDR and IVDR remain subject to the annual maintenance fees.

Conditions

Fee exemption rule expressed here; amounts recorded in the government-fees findings.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Implant card deadline for health institutions

label.implant-card-30-working-days

Fact-level verified

An Irish health institution that implants an implantable device must give the patient the MDR Article 18(1) information and the implant card bearing the patient's identity as soon as possible, and no later than 30 working days after implantation.

Conditions

Obligation on the health institution that performed the implantation; delivery may be by electronic, written or other appropriate means.

Effective from 2021-05-26

National timing delta on the MDR Article 18 implant card.

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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MDR transposition law

legal.md-transposition-si-261-2021

Fact-level verified

Ireland's MDR implementation law is the Medical Devices Regulations 2021 (S.I. No. 261 of 2021), made under section 32 of the Irish Medicines Board Act 1995, in operation from 26 May 2021, for the purpose of giving full effect to Regulation (EU) 2017/745.

Conditions

Companion registration law: S.I. No. 691 of 2021 (medical devices); S.I. No. 256 of 2022 and S.I. No. 365 of 2022 for IVDs.

Effective from 2021-05-26

The brief's tentative citation 'S.I. 760 of 2021' is incorrect; the Medical Devices Regulations 2021 are S.I. No. 261 of 2021.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Post-market surveillance reporting (Arts. 83-86)

pms.reporting-duties-arts-83-86

Fact-level verified

Manufacturers must implement a post-market surveillance system (Art. 83) and a documented post-market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post-market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

Conditions

EU-wide rule under Regulation (EU) 2017/745, which applies directly in the member state; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Clinical investigation submission via CESP

submission.cesp-clinical-investigations

Fact-level verified

Clinical investigation applications and notifications (MDR Art. 62/74/82) are submitted to HPRA through the Common European Submission Portal (CESP), followed by an email to devices@hpra.ie with the CESP reference number; HPRA considers the application complete only after form, fee, CESP submission and notification email.

Conditions

Applies to clinical investigations conducted in Ireland.

Performance study submission via CESP

submission.cesp-performance-studies

Fact-level verified

IVDR performance-study applications and notifications are submitted to HPRA via CESP with an email to devices@hpra.ie quoting the CESP reference number; substantial modifications to approved studies are likewise notified via CESP until the EUDAMED performance-study modules are functional.

Conditions

Contingency channel pending EUDAMED PS module functionality.

Official form or portal surface

submission.official-form-or-portal-surface

Fact-level verified

Submission Surface: HPRA online 'Medical devices economic operator – registration form' (forms.hpra.ie/Economic-Operator-Form) for national registration of economic operators not registering via EUDAMED; EUDAMED for actors registering directly there
Steps: Introduction
Organisation details
Contact details
Details of device types
Terms & conditions
Payment
Preview & submit
Verified Highlights: Payment step collects the registration administration fee (fee code 431).
Registration applications are processed within 10 working days.

Conditions

Live online form on the HPRA Power Apps portal.

Confirms the baseline official-form fact against the live form itself; fee and processing-time statements verified on the custom-made registration page and fee guide.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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HPRA inspections of device actors

qms.hpra-inspection-regime

Fact-level verified

HPRA assesses notified bodies and inspects manufacturers, authorised representatives, distributors, importers, manufacturing facilities, suppliers to manufacturers and third-country sites; inspection fees are EUR 1,995 per day or EUR 285 per hour per team member (codes 471/472), with travel time and expenses chargeable in defined cases; fees and expenses may be waived in exceptional circumstances.

Conditions

Remote assessments incur no additional expense charges; waiver example given: low number of employees and/or turnover.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Enforcement notices and 7-day court appeals

recall.enforcement-notice-appeals

Fact-level verified

HPRA market-surveillance enforcement tools under S.I. 261 of 2021 include quarantine notices, compliance notices and prohibition orders (regs. 31-33); an appeal against a compliance-notice appeal decision lies to the District Court not later than 7 days after the decision, and a prohibition order may be appealed to the Circuit Court in the circuit where it was served not later than 7 days after service.

Conditions

Medical devices; HPRA also publishes appeal procedure guidelines under reg. 15(2) for investigation decisions.

Effective from 2021-05-26

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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National IVD operator registration including importers and distributors

registration.ivd-operator-notification

Fact-level verified

For IVDs, Irish-established manufacturers, authorised representatives, importers and distributors must all notify HPRA (name and place of business; manufacturer details for importers; device category); health institutions with in-house IVDs (reg. 4) and manufacturing facilities (reg. 5) notify separately.

Conditions

Applies to devices placed on the market in the EEA under the IVDR or Directive 98/79/EC via IVDR Art. 110(3).

Unlike the medical-device registration S.I. (which applies importer/distributor registration to devices other than IVDs), the IVD rules extend notification to importers and distributors.

National manufacturer and AR registration (medical devices)

registration.manufacturer-ar-notification-md

Fact-level verified

Manufacturers established in Ireland must notify HPRA of their name, registered place of business and a device-identifying description; manufacturers designating an Irish authorised representative, and authorised representatives established in Ireland, must notify HPRA likewise and furnish evidence of the designation (S.I. No. 691 of 2021 regs. 3(2)-(4)).

Conditions

Applies to devices placed on the market in the EEA under the MDR (and legacy Directive devices during transition); notification is 'in the manner prescribed by the Authority', i.e. the HPRA online registration form; separate categories cover custom-made manufacturers (reg. 5), system/procedure pack producers (reg. 6) and health institutions with in-house devices (reg. 7).

Confirms and re-sources the baseline market-access-route fact from national law instead of EUR-Lex.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Ireland approvals and evidence in other markets (10 records)

BahrainSaudi Arabia · US FDA · Australia TGA · Japan MHLW / PMDA · UK MHRA · Ireland · Swissmedic · France · Germany

Prior approval / evidence record

Registration certificate from SFDA (Saudi Arabia), US FDA, TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) or BfArM (Germany)

Authority: Registration certificate from SFDA (Saudi Arabia), US FDA, TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) or BfArM (Germany)
Accepted: Yes
Benefit: Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides by way of exception to the ordinary Article (7) prohibition that medical devices and products registered in one of the nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of that country's registration certificate, on payment of the applicable fee. This is a documentary registration route rather than a full de novo technical assessment, but the application is still filed by a licensed Bahraini Authorized Representative and NHRA retains the decision.

NHRA Medical Devices Registration Guideline, Version 9.1 (September 2024) — general rules, process of submission, variation and renewal NHRA Medical Device Classification Guideline, Version 2.4 (June 2022) — important rules, classification review time NHRA Medical Device Registration SLA 2025 — service completion time

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

BahrainUS FDA · Japan MHLW / PMDA · Saudi Arabia · Australia TGA · UK MHRA · Ireland · Swissmedic · France · Germany

Prior approval / evidence record

Registration certificate from a listed reference country is an alternative basis for Bahraini registration (Art. 7 bis)

reliance.reference-country-registration-certificate-route

Fact-level verified

Statement: Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides that by way of exception to the ordinary Article (7) prohibition, medical devices and products registered in one of nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of the registration certificate issued by that country, following payment of the applicable fee. The listed reference authorities are SFDA (Saudi Arabia), FDA (United States), TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) and BfArM (Germany). A holder of a US FDA or Japan PMDA registration therefore has a documentary registration route in Bahrain rather than a full de novo technical assessment.
Source Approval: US FDA registration/clearance; Japan PMDA approval; Saudi SFDA registration; Australia TGA registration; UK MHRA registration; Ireland HPRA registration; Swissmedic (Switzerland) registration; France ANSM registration; Germany BfArM registration
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Only the nine authorities named in Article (7) bis are listed; Korea MFDS, Health Canada and China NMPA are not among them
The EU CE mark as such is not listed; the Union route appears only through three named national authorities (HPRA, ANSM, BfArM)
The application is still made by a Bahraini licensed Authorized Representative and the applicable fee must be paid
In force from the day following publication in the Official Gazette (No. 3781, 21 November 2024)
Resolution No. (69) of 2024 replaced Article (10) of Resolution No. (48) of 2020 so that marketing authorisation runs for three years

Effective from 2024-11-22

Verbatim source passage: "By way of exception to Article (7) of this Resolution, medical devices and products registered in one of the following reference countries shall also be registered in the Kingdom of Bahrain: 1. Kingdom of Saudi Arabia - Represented by the Saudi Food and Drug Authority (SFDA). 2. United States of America - Represented by the Food and Drug Administration (FDA). 3. Australia - Represented by the Therapeutic Goods Administration (TGA). 4. Japan - Represented by the Pharmaceuticals and Medical Devices Agency (PMDA). 5. United Kingdom - Represented by the Medicines and Healthcare products Regulatory Agency (MHRA). 6. Ireland - Represented by the Health Products Regulatory Authority (HPRA). 7. Switzerland - Represented by Swissmedic(Swissmedic). 8. France - Represented by the French National Agency for Medicines and Health Products Safety (ANSM). 9. Germany - Represented by the Federal Institute for Drugs and Medical Devices (BfArM). Based on the registration certificate issued by one of these countries, following the payment of the applicable fee."

BahrainSaudi Arabia · US FDA · UK MHRA · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Ireland · Denmark · New Zealand · France · Netherlands · Belgium

Prior approval / evidence record

Free Sale Certificate may be issued by the country of origin or by a reference country

reliance.free-sale-certificate-origin-or-reference-country

Fact-level verified

Statement: At renewal, Bahrain requires a Free Sale Certificate (FSC) or Certificate to Foreign Government issued by the regulatory authority of the country of origin or of a reference country (Registration Guideline 9.1, section 10 item 4). The guideline's glossary (item 14) defines reference countries as Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland and Belgium, so a certificate from one of those authorities substitutes for an origin-country free-sale certificate. A Free Sale Certificate is also required on manufacturer acquisition (section 12).
Source Approval: Free Sale Certificate or Certificate to Foreign Government from the country of origin or from a reference country (Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium)
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The classification guideline separately accepts a Free Sale Certificate OR Registration Certificate from one of the reference countries as a classification requirement
The reference-country list in the registration guideline glossary includes Canada, Denmark, the Netherlands ('Holland') and New Zealand, which are not in the Article (7) bis list of Resolution No. (69) of 2024, and omits Germany
Free Sale Certificate is also required on manufacturer acquisition (Section 12)

Verbatim source passages: "Free Sale Certificate (FSC) or Certificate to foreign government issued by the regulatory authority of the country of origin or a reference country." and "Reference countries: Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium."

BahrainSaudi Arabia · US FDA · UK MHRA · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Ireland · Denmark · New Zealand · France · Netherlands · Belgium

Prior approval / evidence record

Classification of a product as a medical device may be evidenced by a registration certificate from a reference country

reliance.reference-country-certificate-for-classification

Fact-level verified

Statement: To obtain an NHRA classification letter, the applicant must supply a Free Sale Certificate or Registration Certificate issued by the competent authority of the country of origin or by one of the reference countries listed in the classification guideline (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium), together with a recognised quality assurance certificate such as ISO 13485, CE mark or FDA.
Source Approval: Registration certificate or Free Sale Certificate from SFDA (Saudi Arabia), US FDA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland or Belgium
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: classification
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

A classification letter is a separate, fee-bearing NHRA service that precedes importation and registration
The reference-country list here is broader than the Article (7) bis list in Resolution No. (69) of 2024 and omits Germany and includes Canada, Denmark, the Netherlands and New Zealand
For class I products without CE marking a manufacturer's Declaration of Conformity may be provided

Verbatim source passage: "1. Free Sale Certificate OR Registration Certificate issued from competent authority in country of origin classifies the product as a medical device. 2. Free Sale Certificate OR Registration Certificate issued from one of the following reference countries: (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, Newzland, France, and Holland, Belgium.)."

EgyptUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · Norway · New Zealand · Ireland · Iceland

Regulatory reference

List of reference countries

reliance.reference-countries

Fact-level verified

EDA recognizes reference countries: EU member states plus Australia, Canada, Iceland, Ireland, Japan, New Zealand, Norway, Switzerland, United Kingdom and United States of America; devices from these countries get reduced documentation, while devices from non-reference countries need extra evidence.

Variation guideline v03 (res-eg-variations) lists the same set plus Croatia and Liechtenstein.

IsraelUS FDA · UK MHRA · Germany · France · Italy · Spain · Netherlands · Belgium · Ireland · Denmark · Sweden · Finland · Norway · Iceland · Greece · Portugal · Austria · Swissmedic · Australia TGA · Health Canada · New Zealand

Regulatory reference

Recognized-state registration route

reliance.recognized-country-route

Fact-level verified

A device registered, or approved for marketing and actually marketed, in a 'recognized state' (מדינה מוכרת) is registered in the Israeli register for a period not exceeding the period it may be marketed in that state, capped at 5 years from Israeli registration. Recognized states are listed in the First Addendum to the law — 21 states including the US, UK, Germany, France, Italy, Spain, the Netherlands, Belgium, Ireland, Denmark, Sweden, Finland, Norway, Iceland, Greece, Portugal, Austria, Switzerland, Australia, Canada and New Zealand (no single 'EU' entry: member states are listed individually).

Conditions

Device must be registered or permitted for marketing and actually marketed in the recognized state.

First Addendum list per the official Sefer HaChukim text of the law held from gov.il.

KenyaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Ireland · Saudi Arabia

Regulatory reference

Recognized reference regulatory agencies

reliance.reference-agencies

Fact-level verified

The medical device registration guideline recognizes marketing clearances from eight listed reference regulatory agencies: Australia TGA, Health Canada, EU Notified Bodies (MDD/AIMDD/IVD Directive certificates), Japan MHLW, US FDA (510(k) or PMA), Ireland HPRA, Saudi Arabia SFDA and Swissmedic. US FDA 510(k)-exempt products do not qualify for the abridged route. Approvals from EU and TGA count as independent reference approvals only if the devices were reviewed and approved by those agencies themselves and not registered on the basis of a Mutual Recognition Agreement (MRA).

Conditions

Used to qualify devices for abridged, expedited (EBR/ECR/EDR) and immediate (IBR) routes.
Applies at the time of application.

PakistanAustralia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · US FDA · Austria · Belgium · Denmark · France · Germany · Ireland · Italy · Netherlands · Norway · Spain · Sweden · WHO · EU conformity assessment

Regulatory reference

Rule 67 lists reliance reference countries plus WHO prequalification and CE marking

reliance-reference-countries

Fact-level verified

Rule 67 names the reference countries and schemes whose market authorisations DRAP relies on: USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and United Kingdom, or devices pre-qualified by the World Health Organization, or CE marked by conformity assessment bodies (CABs) notified in the NANDO database under the relevant European directive for medical devices, subject to evidence and supporting documents.

Conditions

Reliance subject to evidence and supporting documents

Effective from 2018-01-16

ParaguayBrazil ANVISA · US FDA · Health Canada · Austria · Belgium · Denmark · Finland · France · Germany · Hungary · Ireland · Italy · Netherlands · New Zealand · Norway · Spain · Sweden · Japan MHLW / PMDA · UK MHRA · Swissmedic · Australia TGA · WHO

Prior approval / evidence record

IVD Annex I reference-country list drives the 30/45/120-business-day clocks

reliance.ivd-anexo-i-reference-country-list

Fact-level verified

Statement: For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free-sale certificate), and within 120 business days for other imports. Annex I names high-surveillance and adequate-surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not.
Source Approval: Sanitary registration and free-sale certificate in force in an Annex I country — high-surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate-surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The Annex I list derives from Ley N° 3283/2007 Art. 11 (high and adequate sanitary surveillance).
A product made outside Annex I is admitted on a 45-day clock only if it is registered and commercialised in an Annex I country.
Korea (MFDS) does not appear in Annex I, so a Korean-only IVD authorisation does not by itself reach the 30/45-day clocks.
A Paraguayan sanitary registration is still required in every case.

Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.

PeruUS FDA · UK MHRA · Health Canada · Japan MHLW / PMDA · Australia TGA · Swissmedic · South Korea MFDS · Germany · France · Netherlands · Spain · Italy · Belgium · Portugal · Ireland · Austria · Hungary · Denmark · Norway · Sweden

Prior approval / evidence record

País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden

Authority: País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
Accepted: Yes
Benefit: The Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.
Timeline Savings: None published — the TUPA period is set by class, not by origin

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods Peru D.S. 016-2011-SA — Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (arts. 7 and 9, as amended)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Prior approvals and evidence for Ireland (3 records)

IrelandNMPA

Regulatory reference

NMPA certificate does not replace EU conformity assessment

reliance.china-nmpa-no-recognition-route

Fact-level verified

Statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: ireland
China Classes In Scope: All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: null
Target Decision Retained: null

Conditions

Determine the local class independently; NMPA Class III is not an automatic EU class assignment.
A local regulatory application/decision is not universal: MDR Article 52(7) and IVDR Article 48(10) permit specified self-declaration routes.
Clinical, performance and technical evidence must meet the applicable EU requirements; the certificate alone does not replace them.
Special-purpose, investigational, custom-made and derogation regimes require separate assessment.

MDR consolidated text, 19 July 2026 IVDR consolidated text, 10 January 2025

Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.

IrelandEU conformity assessment

Prior approval / evidence record

EU CE under MDR/IVDR — single market validity

reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-ireland

Fact-level verified

Target: geo:irl
Source Approval: EU CE under MDR/IVDR
Edge Type: Single Market Validity
Market Access Strength: direct
Regulatory Layer: Product Marketing
Same Device Required: Yes
Local Application Required: No
Target Decision Retained: No

Conditions

medical devices and IVDs subject to route-specific scope
valid CE conformity route for the device
country language, economic-operator, EUDAMED, and national vigilance obligations still apply

Re-verified on the Commission CE-marking page; national operator registration and vigilance channels in Ireland are recorded as separate facts.

IrelandUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)EUR-Lex Regulation (EU) 2017/745 (MDR)EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Genetic test information and counselling requirement

derogation.genetic-testing-info

Fact-level verified

Ireland exercised the IVDR Article 4(3) option: where a genetic test is used on an individual in the context of healthcare, the individual (or legally designated representative) must be provided with relevant information on the nature, significance and implications of the test; for untreatable conditions the person must be appropriately counselled, except where a diagnosis is confirmed by the genetic test or a companion diagnostic is used.

Conditions

National rule applicable in Ireland in addition to IVDR Article 4(1)-(2).

Effective from 2022-05-26

Single-use device reprocessing condition

derogation.reprocessing-single-use

Fact-level verified

A person may not reprocess a single-use device to make it suitable for further use in Ireland unless there is compliance with MDR Article 17(6), (7) and (8); a reprocessor assumes the obligations incumbent on manufacturers.

Conditions

National restatement of the MDR Article 17 conditions with direct effect in Irish law.

Effective from 2021-05-26

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Clinical investigation appeal within 28 days

appeal.ci-decision-28-days

Fact-level verified

A sponsor may appeal HPRA decisions within 28 days of receipt: refusal of clinical-investigation authorisation (MDR Art. 70(3)), decisions under Art. 71(4), and refusal of substantial-modification authorisation (Art. 75(3)(a)); HPRA publishes guidelines on appeal procedures.

Conditions

Time limit runs from receipt of the relevant decision from the Authority.

Effective from 2021-05-26

HPRA appeal route via Advisory Committee

appeal.hpra-advisory-committee-route

Fact-level verified

HPRA appeals for clinical-investigation objections (and clinical-trial non-acceptances) are submitted to the relevant statutory Advisory Committee within 28 days of notification and decided by the Authority (the nine HPRA members); classification decisions are appealed to the HPRA Leadership Team. HPRA states only classification decisions and objections to clinical trials and clinical investigations are appealable, and an appeal fee applies per the Guide to Fees.

Conditions

Refusal proposals additionally go through the refusals procedure with written/oral representation rights and Advisory Committee advice.

Performance study appeal within 30 days

appeal.ps-decision-30-days

Fact-level verified

IVD performance-study decisions may be appealed to HPRA not later than 30 days after notice of the decision: Article 66(3) authorisation refusals, decisions under Article 67(4), and refusal of authorisation for a substantial modification under Article 71(3)(a).

Conditions

Appeal is submitted to the Authority itself under the national procedure.

Effective from 2022-05-26

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Unique Device Identification system (Art. 27)

udi.udi-system-art-27

Fact-level verified

Devices other than custom-made and investigational devices carry a Unique Device Identification consisting of a UDI device identifier (UDI-DI) specific to a manufacturer and a device and a UDI production identifier (UDI-PI) identifying the unit of device production; the UDI is placed on the label of the device or on its packaging and is stored, together with the related device identifiers, by economic operators, health institutions and healthcare professionals under the conditions laid down in Art. 27.

Conditions

EU-wide rule under Regulation (EU) 2017/745, which applies directly in the member state; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

National vigilance reporting channel

vigilance.email-channel

Fact-level verified

Manufacturers and authorised representatives submit vigilance reports to HPRA by email at devicesafety@hpra.ie (national channel alongside EUDAMED); the vigilance requirements are those of MDR/IVDR Chapter VII Section 2 and the reporting forms are the EU Commission (MDCG) forms.

Conditions

Applies to devicesafety@hpra.ie as the HPRA contingency channel for vigilance reporting.

Importer/distributor serious-risk and falsified-device duty

vigilance.importer-distributor-serious-risk

Fact-level verified

An importer or distributor in Ireland that suspects a device presents a serious risk, or is a falsified device, must inform HPRA at once by email at devicesafety@hpra.ie.

Conditions

National reporting channel for the MDR/IVDR distributor and importer obligations.

Related structured datasets

Classification systems · 1 record

Open EU MDR classes I, Is, Im, Ir, IIa, IIb and III →

ireland:medical-device

Jurisdiction Id

ireland

Domains

medical-device

Name

EU MDR classes I, Is, Im, Ir, IIa, IIb and III

Description

National projection of the directly applicable EU MDR classification. The canonical class axis and rules are maintained in eu:medical-device; national references describe only administration or local deltas.

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
is
Label
Class Is
Normalized Risk Level
low
Id
im
Label
Class Im
Normalized Risk Level
low
Id
ir
Label
Class Ir
Normalized Risk Level
low
Id
iia
Label
Class IIa
Normalized Risk Level
medium
Id
iib
Label
Class IIb
Normalized Risk Level
high
Id
iii
Label
Class III
Normalized Risk Level
highest

Regulator

HPRA

Official Domains

hpra.ie
eur-lex.europa.eu
europa.eu

Source Status

official-source-verified

Reference Sources

Title
FIN-G0002-38, section 9.9 'Determination of classifications within the medical devices regulations'; appeal route per AU
Url
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/fin-g0002-guide-to-fees-for-human-products-v38.pdf?sfvrsn=dd51febb_59
Reviewed On
2026-08-25
Supports
Ireland applies the EU MDR/IVDR classification rules directly (no national classification scheme); national overlay is procedural only: HPRA determines classification on request (EUR 335, code 481; EUR 1,210 complex, code 492), handles MDR Article 51 / IVDR Article 47 referrals (EUR 10,760, code 437), and classification opinions are appealable (EUR 655, code 483) to the HPRA Leadership Team

Inherited From Scheme Id

eu:medical-device

Source Title

Regulation (EU) 2017/745, Art. 51 and Annex VIII

Source Url

https://eur-lex.europa.eu/eli/reg/2017/745/oj

Verified On

2026-08-26

Source Supports

class-axis
classification-rules

Registration pathways, prior approvals and planning · 1 record

Open Ireland registration →

Country

Ireland

Jurisdiction Id

ireland

Country Code

Flag

🇮🇪

Regulator

Health Products Regulatory Authority

Regulator Abbrev

HPRA

Region

europe

Tier

Risk Classification

4-class (I, IIa, IIb, III) — EU MDR

Classes

Id
class-i
Class Name
Class I
Risk Level
low
Pathway
Self-declaration (no notified body)
Official Timeline
Min
0
Max
0
Unit
days
Verification Status
official-verified
Official Source
Title
EUR-Lex Regulation (EU) 2017/745 (MDR)
Url
https://eur-lex.europa.eu/eli/reg/2017/745/oj
Accessed Date
2026-08-25
Realistic Timeline
Min
6
Max
9
Unit
months
Notes
MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock
Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes

Key Requirements

EU Authorized Representative (for non-EU manufacturers)
EUDAMED and national economic-operator registration processed within 10 working days
MDR Art. 62 clinical investigations: validation 10-15 calendar days, outcome within 45 calendar days of validation (+20 with experts), sponsor response time excluded (AUT-G0095-7)
IVDR performance studies: validation on receipt, outcome within 45 calendar days (+20); Art. 58(1) studies without major clinical-risk procedures may commence after validation, others after authorisation (AUT-G0176-2)

Prior Approvals

Authority
FDA 510(k)/PMA
Accepted
No
Benefit
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Local Rep Required

Yes

Local Rep Name

EU Authorized Representative

Mdsap Accepted

Mdsap Benefit

ISO 13485 accepted as QMS evidence

Registration Validity

5 years (CE certificate)

Last Updated

2026-08-29

Verification Status

partially-verified

Official Sources

Title
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
Url
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
Effective Date
2027-02-25
Accessed Date
2026-08-29
Title
EUR-Lex Regulation (EU) 2017/745 (MDR)
Url
https://eur-lex.europa.eu/eli/reg/2017/745/oj
Accessed Date
2026-08-25
Title
EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)
Url
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110
Accessed Date
2026-08-29

Reviewed On

2026-08-29

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by HPRA. Appoint a EU Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to HPRA including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
HPRA reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. HPRA may issue questions.
Duration
0 days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, HPRA issues Ireland market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

Open Ireland fees →

Jurisdiction Id

ireland

Country

Ireland

Country Code

Authority

HPRA

Low Risk Local

Min: 150
Max: 150
Currency: EUR
Per Product: No

High Risk Local

Min: 33430
Max: 33430
Currency: EUR
Per Product: No

Details

Id
manufacturer-registration
Item
Manufacturer establishment registration (code 431)
Currency
EUR
Amount Local
150
Amount Local Formatted
EUR 150
Frequency
Per registration
Notes
Not charged where registration is effected directly through EUDAMED.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
annual-manufacturer-fee
Item
Annual manufacturer fee by employee count (codes 458–462, 470)
Currency
EUR
Amount Local
33430
Amount Local Min
275
Amount Local Max
33430
Amount Local Formatted
EUR 275–33,430
Frequency
Per year
Notes
Tiers: EUR 33,430 / 22,285 / 16,715 / 5,570 / 1,395 / 275.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
annual-ar-type-i-fee
Item
Annual authorised-representative fee - Type I
Currency
EUR
Amount Local
1200
Amount Local Formatted
EUR 1,200
Frequency
Per year
Notes
Capped at EUR 6,000.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
annual-ar-type-ii-fee
Item
Annual authorised-representative fee - Type II
Currency
EUR
Amount Local
1635
Amount Local Formatted
EUR 1,635
Frequency
Per year
Notes
Capped at EUR 8,175.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
annual-distributor-importer-fee
Item
Annual distributor/importer fee by employee count
Currency
EUR
Amount Local
5015
Amount Local Min
275
Amount Local Max
5015
Amount Local Formatted
EUR 275–5,015
Frequency
Per year
Notes
Tiers: EUR 5,015 / 2,790 / 1,395 / 275; dual distributor-importer roles over 3 million pay an additional EUR 1,090.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
clinical-investigation-application
Item
Clinical-investigation application
Currency
EUR
Amount Local
2075
Amount Local Min
2075
Amount Local Max
4700
Amount Local Formatted
EUR 2,075–4,700
Frequency
Per application
Notes
Class III/IIb: EUR 4,700; Class IIa/I: EUR 2,075.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
clinical-investigation-notification
Item
Clinical-investigation notification (Art. 74-type)
Currency
EUR
Amount Local
220
Amount Local Formatted
EUR 220
Frequency
Per notification
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
ivd-performance-study-application
Item
IVD performance-study application
Currency
EUR
Amount Local
2725
Amount Local Formatted
EUR 2,725
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
clinical-substantial-modification
Item
Substantial modification of an investigation/study
Currency
EUR
Amount Local
1360
Amount Local Formatted
EUR 1,360
Frequency
Per modification
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
clinical-resubmission
Item
Resubmission of an investigation/study application
Currency
EUR
Amount Local
2075
Amount Local Formatted
EUR 2,075
Frequency
Per resubmission
Notes
Academic-sponsored resubmissions: EUR 560.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
free-sale-certificate
Item
Free-sale certificate
Currency
EUR
Amount Local
280
Amount Local Formatted
EUR 280
Frequency
Per certificate
Notes
Covers up to four products; each additional product EUR 25.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
registration-letter
Item
Registration status letter
Currency
EUR
Amount Local
130
Amount Local Formatted
EUR 130
Frequency
Per letter
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
digital-certificate
Item
Digital certificates (certified copies)
Currency
EUR
Amount Local
200
Amount Local Formatted
EUR 200
Frequency
Per certificate
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
article-59-assessment
Item
Assessment of an MDR Art. 59 exemption request
Currency
EUR
Amount Local
4370
Amount Local Formatted
EUR 4,370
Frequency
Per assessment
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25
Id
classification-decision
Item
Classification determination
Currency
EUR
Amount Local
10760
Amount Local Min
335
Amount Local Max
10760
Amount Local Formatted
EUR 335–10,760
Frequency
Per determination
Notes
EUR 335 / 1,210 / 10,760 / 655 by determination type.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Source Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Verified On
2026-08-25

Notes

Notified-body designation fees (EUR 11,145 / 5,570 plus EUR 1,995 per assessor day) are charged to the bodies; total annual fees per organisation are capped at EUR 66,860.
HPRA fee codes referenced (431, 458–462, 470) come from the published account structure.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
HPRA FIN-F0018 fee application form for human products (device fee codes)
Url
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
Accessed Date
2026-08-25
Title
HPRA FIN-G0002 guide to fees for human products (device sections)
Url
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/fin-g0002-guide-to-fees-for-human-products-v38.pdf?sfvrsn=dd51febb_59
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

Open Ireland certifications →

Slug

ireland

Market

Ireland

Confidence

high

Schemes

Id
lvd-medical-exclusion-mdr-electrical-safety
Name
MDR electrical safety in place of the Low Voltage Directive
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so there is no separate national electrical-safety certificate for a medical device. Electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity.
Source Urls
https://eur-lex.europa.eu/eli/dir/2014/35/oj
Source Binding
candidate
Id
emc-directive-disapplied-by-mdr
Name
MDR electromagnetic compatibility in place of the EMC Directive
Category
emc
Status
Included In Medical Registration
Object
Finished Device
Note
Article 2(3) of Directive 2014/30/EU switches the EMC Directive off where other Union legislation lays the same essential requirements down more specifically, which MDR Annex I sections 18.5 and 18.6 do for medical devices. EMC is therefore dossier evidence inside the CE route and not a separate national EMC conformity step.
Source Urls
https://eur-lex.europa.eu/eli/dir/2014/30/oj
Source Binding
candidate
Id
si-14-2026-radio-equipment-regulations
Name
European Union (Radio Equipment) Regulations 2026
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Equipment
Note
S.I. No. 14 of 2026 replaced and revoked S.I. No. 248 of 2017 and the 2024 amendment, so the 2017 instrument is no longer operative even though it is still widely cited. Regulation 34(1) designates the Commission for Communications Regulation as the market surveillance authority for radio equipment, and Regulation 24 makes it the notifying authority. Regulation 8(1) provides that nothing in the Regulations impedes making compliant radio equipment available, and Regulation 60(2) provides that nothing in the Wireless Telegraphy Acts 1926 to 1988 restricts use of apparatus that complies with the Directive, save for spectrum efficiency, harmful interference and public health. That is an express statutory negative on national product approval.
Source Urls
https://www.irishstatutebook.ie/eli/2026/si/14/made/en/print
Source Binding
reviewed
Id
si-513-2012-rohs-substance-restriction
Name
European Union (RoHS) Regulations 2012 substance restriction
Category
Environmental And Batteries
Status
Evidence Only No Separate Certificate
Object
Electrical Electronic Medical Device
Note
Regulation 5(1) of S.I. No. 513 of 2012, as amended by S.I. No. 428 of 2022, provides that EEE placed on the market shall not contain the substances listed in Annex II to the Directive. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.
Source Urls
https://www.irishstatutebook.ie/eli/2012/si/513/made/en/print
Source Binding
reviewed
Id
si-149-2014-weee-producer-registration
Name
WEEE producer registration with the registration body
Category
Environmental And Batteries
Status
Mandatory Pre Market
Object
Producer Or Authorised Representative
Note
Ireland gates market access on registration in terms. Regulation 10(5) of S.I. No. 149 of 2014 obliges every producer that has placed EEE on the market in the State to be registered with the registration body, and Regulation 10(6) provides that a producer who fails to comply, who is deemed not to be registered under Regulation 12(2), or whose renewal is refused under Regulation 12(4), shall not place electrical and electronic equipment on the market. Producer Register Limited is the body approved by the Minister under section 53J of the Waste Management Act 1996; the EPA enforces. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.
Source Urls
https://www.irishstatutebook.ie/eli/2014/si/149/made/en/print
Source Binding
reviewed
Id
si-283-2014-battery-producer-registration
Name
Battery producer registration with the registration body
Category
Environmental And Batteries
Status
Mandatory If Feature
Object
Battery Producer Or Authorised Representative
Note
Regulation 15(1) of S.I. No. 283 of 2014 requires the registration body to establish and maintain a register of producers placing batteries on the market, and Regulation 17(2) prohibits a producer who has not registered, or who is deemed not registered under Regulation 19(2), from placing batteries on the market in the State. S.I. No. 165 of 2026 amends that instrument to give effect to Articles 54, 55 and 58 of Regulation (EU) 2023/1542; its text was not read, so the 2014 numbering should be re-checked against the amendment before relying on it. Article 11(2)(b) of Regulation (EU) 2023/1542 lets professional medical imaging and radiotherapy devices and in vitro diagnostic medical devices restrict portable-battery replacement to independent professionals, and Article 11(3) lifts the removability duty where continuity of supply is needed for safety or data integrity.
Source Binding
unresolved
Id
epa-radiation-practice-registration-or-licence
Name
EPA radiation practice registration or licence
Category
Ionizing Radiation
Status
Mandatory If Feature
Object
Radiation Generator Source Or Product Practice
Source Binding
unresolved

Official Sources

Authority
EUR-Lex
Topic
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
Url
https://eur-lex.europa.eu/eli/dir/2014/35/oj
Authority
EUR-Lex
Topic
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
Url
https://eur-lex.europa.eu/eli/dir/2014/30/oj
Authority
EUR-Lex
Topic
RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates
Url
https://eur-lex.europa.eu/eli/dir/2011/65/oj
Authority
EUR-Lex
Topic
WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register
Url
https://eur-lex.europa.eu/eli/dir/2012/19/oj
Authority
EUR-Lex
Topic
Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register
Url
https://eur-lex.europa.eu/eli/reg/2023/1542/oj
Authority
Irish Statute Book (Office of the Attorney General)
Topic
S.I. No. 14/2026 European Union (Radio Equipment) Regulations 2026 — ComReg designation, free movement and revocation of S.I. 248/2017
Url
https://www.irishstatutebook.ie/eli/2026/si/14/made/en/print
Authority
Irish Statute Book (Office of the Attorney General)
Topic
S.I. No. 513/2012 RoHS Regulations regulation 5(1) substance prohibition
Url
https://www.irishstatutebook.ie/eli/2012/si/513/made/en/print
Authority
Irish Statute Book (Office of the Attorney General)
Topic
S.I. No. 149/2014 WEEE Regulations regulation 10(5) and 10(6) — registration as a precondition for placing EEE on the market
Url
https://www.irishstatutebook.ie/eli/2014/si/149/made/en/print
Authority
Irish Statute Book (Office of the Attorney General)
Topic
S.I. No. 283/2014 Batteries and Accumulators Regulations regulations 15 and 17 — producer register and market bar
Url
https://www.irishstatutebook.ie/eli/2014/si/283/made/en/print
Authority
Office of the Attorney General (Irish Statute Book)
Topic
S.I. No. 30/2019 graded authorisation of ionising radiation practices
Url
https://www.irishstatutebook.ie/eli/2019/si/30/made/en/print

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