HPRA market access

Ireland medical device registration resources

Research HPRA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Ireland medical device resource.

3 free resourcesAug 2026 fees reviewed

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Everything we track for Ireland

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Medical device regulation news

Follow recent Health Products Regulatory Authority (HPRA) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary HPRA risk class with official rule references.

Government registration fees

Review current HPRA application, review, and renewal fees.

Government fees

Full fee schedule (15 lines) →

HPRA registration fees in EUR · reviewed 2026-08-25

Fee line	Amount	Provenance
Manufacturer establishment registration (code 431)	EUR 150	Verified
Annual manufacturer fee by employee count (codes 458–462, 470)	EUR 275–33,430	Verified
Annual authorised-representative fee - Type I	EUR 1,200	Verified
Annual authorised-representative fee - Type II	EUR 1,635	Verified

11 more fee lines on the full schedule · 15 of 15 rows source-verified

Latest regulation news

All Ireland regulation news →

Newest HPRA-related headlines from the daily-refreshed feed — every row links to the publishing source.

Aug 26MGMedEnvoy GlobalWhat Is a Saudi Arabia Authorized Representative for Medical Devices?

Ireland Aug 26OSOperon StrategistSFDA Medical Device Establishment License (MDEL): Complete Compliance Guide

Ireland Aug 25MGMedEnvoy GlobalHow Does Mexico Classify Single-Use Versus Reusable Medical Devices?

Ireland Aug 25FLFDA Law BlogFDA Addresses Device Constituents in New Draft Guidance on Container Closure Systems

Ireland Aug 25PBPacific BridgeCan Foreign Clinical Data be Used to Get Your Medical Device Approved in Japan?

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The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.

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Build a reusable product master

Structure company, product, model, approval, certificate, and evidence facts before starting Ireland work.

Ireland market-launch workpaper

Connect the HPRA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

Ireland dossier reuse and delta

Compare an existing authorization and evidence set against HPRA administrative, testing, labeling, and dossier needs.

Ireland change notification workpaper

Map a product or manufacturing change to HPRA evidence, notification, timing, and implementation questions.

Ireland regulatory change impact

Assess a current HPRA update against one product and turn it into an owner-ready action workpaper.

Ireland cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Ireland (HPRA).

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Local representation, HPRA submissions, and lifecycle maintenance — handled with an expert.