Explore the IVD requirements currently available for Ireland, organized by topic and linked to official sources.
Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
What expires, what is retained periodically, and when must renewal start?
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.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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.
Which clinical or IVD performance evidence or study is required and accepted?
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.
Effective from 2022-05-26
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).
IVD channel per AUT-G0176-2 section 7.
Is the product a device, IVD, accessory, software, or borderline product locally?
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.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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).
Which establishment licences, importer permissions, and distribution controls apply?
'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.
What regulator fee applies to this class, route, event, and date?
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.
Which current form, portal, account, and submission package must be used?
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.
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
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.
Which QMS, audit, inspection, and certificate scope is accepted or required?
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.
Which registration, notification, listing, reliance, or conformity route applies?
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.
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.
Which foreign decisions or evidence can be reused, with what effect and conditions?
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.
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)
Yes
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.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
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.
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
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
Yes
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."
Prior approval / evidence record
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).
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)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
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."
Prior approval / evidence record
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.
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
Origin Country Evidence
Evidence Only
classification
Yes
Yes
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.)."
Regulatory reference
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).
First Addendum list per the official Sefer HaChukim text of the law held from gov.il.
Prior approval / evidence record
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.
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
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
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.
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
Yes
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.
None published — the TUPA period is set by class, not by origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
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.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
ireland
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Prior approval / evidence record
geo:irl
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Re-verified on the Commission CE-marking page; national operator registration and vigilance channels in Ireland are recorded as separate facts.
Prior approval / evidence record
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
What review, validation, and applicant stop-clock rules apply?
In HPRA clinical-investigation and performance-study assessments, time taken by the sponsor to provide requested information is excluded from the 45-calendar-day review clock; failure to respond can lead to rejection or refusal.
Stop-clock rule recorded as a fact because fee/timeline datasets cannot express it.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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.
Effective from 2022-05-26
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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.
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).
Effective from 2022-05-26
What is reportable, by whom, where, in what format, and by what deadline?
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.
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.
No maintained record.
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
Ireland
ireland
IE
🇮🇪
Health Products Regulatory Authority
HPRA
europe
3
4-class (I, IIa, IIb, III) — EU MDR
class-i
Class I
low
Self-declaration (no notified body)
0
0
days
official-verified
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
6
9
months
No
No
Yes
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Yes
EU Authorized Representative
No
ISO 13485 accepted as QMS evidence
5 years (CE certificate)
2026-08-29
partially-verified
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
2027-02-25
2026-08-29
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
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)
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110
2026-08-29
2026-08-29
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by HPRA. Appoint a EU Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to HPRA including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
HPRA reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. HPRA may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, HPRA issues Ireland market authorization certificate.
1-2 weeks
✅
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
ireland
Ireland
IE
HPRA
150
150
EUR
No
33430
33430
EUR
No
manufacturer-registration
Manufacturer establishment registration (code 431)
EUR
150
EUR 150
Per registration
Not charged where registration is effected directly through EUDAMED.
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
annual-manufacturer-fee
Annual manufacturer fee by employee count (codes 458–462, 470)
EUR
33430
275
33430
EUR 275–33,430
Per year
Tiers: EUR 33,430 / 22,285 / 16,715 / 5,570 / 1,395 / 275.
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
annual-ar-type-i-fee
Annual authorised-representative fee - Type I
EUR
1200
EUR 1,200
Per year
Capped at EUR 6,000.
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
annual-ar-type-ii-fee
Annual authorised-representative fee - Type II
EUR
1635
EUR 1,635
Per year
Capped at EUR 8,175.
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
annual-distributor-importer-fee
Annual distributor/importer fee by employee count
EUR
5015
275
5015
EUR 275–5,015
Per year
Tiers: EUR 5,015 / 2,790 / 1,395 / 275; dual distributor-importer roles over 3 million pay an additional EUR 1,090.
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
clinical-investigation-application
Clinical-investigation application
EUR
2075
2075
4700
EUR 2,075–4,700
Per application
Class III/IIb: EUR 4,700; Class IIa/I: EUR 2,075.
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
clinical-investigation-notification
Clinical-investigation notification (Art. 74-type)
EUR
220
EUR 220
Per notification
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
ivd-performance-study-application
IVD performance-study application
EUR
2725
EUR 2,725
Per application
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
clinical-substantial-modification
Substantial modification of an investigation/study
EUR
1360
EUR 1,360
Per modification
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
clinical-resubmission
Resubmission of an investigation/study application
EUR
2075
EUR 2,075
Per resubmission
Academic-sponsored resubmissions: EUR 560.
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
free-sale-certificate
Free-sale certificate
EUR
280
EUR 280
Per certificate
Covers up to four products; each additional product EUR 25.
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
registration-letter
Registration status letter
EUR
130
EUR 130
Per letter
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
digital-certificate
Digital certificates (certified copies)
EUR
200
EUR 200
Per certificate
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
article-59-assessment
Assessment of an MDR Art. 59 exemption request
EUR
4370
EUR 4,370
Per assessment
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
classification-decision
Classification determination
EUR
10760
335
10760
EUR 335–10,760
Per determination
EUR 335 / 1,210 / 10,760 / 655 by determination type.
exact-current
official-verified
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
HPRA FIN-F0018 fee application form for human products (device fee codes)
2026-08-25
2026-08-25
official-verified
HPRA FIN-F0018 fee application form for human products (device fee codes)
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0018-fee-application-form-for-human-products-v34.xlsx?sfvrsn=f1543d72_19
2026-08-25
HPRA FIN-G0002 guide to fees for human products (device sections)
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/fin-g0002-guide-to-fees-for-human-products-v38.pdf?sfvrsn=dd51febb_59
2026-08-25
2026-08-25
exact-current
Yes
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
ireland
Ireland
high
lvd-medical-exclusion-mdr-electrical-safety
MDR electrical safety in place of the Low Voltage Directive
Medical Electrical Safety
Included In Medical Registration
Finished Device
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.
candidate
emc-directive-disapplied-by-mdr
MDR electromagnetic compatibility in place of the EMC Directive
emc
Included In Medical Registration
Finished Device
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.
candidate
si-14-2026-radio-equipment-regulations
European Union (Radio Equipment) Regulations 2026
Radio Spectrum
Mandatory If Feature
Radio Equipment
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.
reviewed
si-513-2012-rohs-substance-restriction
European Union (RoHS) Regulations 2012 substance restriction
Environmental And Batteries
Evidence Only No Separate Certificate
Electrical Electronic Medical Device
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.
reviewed
si-149-2014-weee-producer-registration
WEEE producer registration with the registration body
Environmental And Batteries
Mandatory Pre Market
Producer Or Authorised Representative
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.
reviewed
si-283-2014-battery-producer-registration
Battery producer registration with the registration body
Environmental And Batteries
Mandatory If Feature
Battery Producer Or Authorised Representative
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.
unresolved
epa-radiation-practice-registration-or-licence
EPA radiation practice registration or licence
Ionizing Radiation
Mandatory If Feature
Radiation Generator Source Or Product Practice
unresolved
EUR-Lex
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
https://eur-lex.europa.eu/eli/dir/2014/35/oj
EUR-Lex
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
https://eur-lex.europa.eu/eli/dir/2014/30/oj
EUR-Lex
RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates
https://eur-lex.europa.eu/eli/dir/2011/65/oj
EUR-Lex
WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register
https://eur-lex.europa.eu/eli/dir/2012/19/oj
EUR-Lex
Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register
https://eur-lex.europa.eu/eli/reg/2023/1542/oj
Irish Statute Book (Office of the Attorney General)
S.I. No. 14/2026 European Union (Radio Equipment) Regulations 2026 — ComReg designation, free movement and revocation of S.I. 248/2017
https://www.irishstatutebook.ie/eli/2026/si/14/made/en/print
Irish Statute Book (Office of the Attorney General)
S.I. No. 513/2012 RoHS Regulations regulation 5(1) substance prohibition
https://www.irishstatutebook.ie/eli/2012/si/513/made/en/print
Irish Statute Book (Office of the Attorney General)
S.I. No. 149/2014 WEEE Regulations regulation 10(5) and 10(6) — registration as a precondition for placing EEE on the market
https://www.irishstatutebook.ie/eli/2014/si/149/made/en/print
Irish Statute Book (Office of the Attorney General)
S.I. No. 283/2014 Batteries and Accumulators Regulations regulations 15 and 17 — producer register and market bar
https://www.irishstatutebook.ie/eli/2014/si/283/made/en/print
Office of the Attorney General (Irish Statute Book)
S.I. No. 30/2019 graded authorisation of ionising radiation practices
https://www.irishstatutebook.ie/eli/2019/si/30/made/en/print
