Hip and Knee Implant Claims in Ireland: The Two Routes Explained

What is a hip and knee implant claim?

A hip and knee implant claim is a civil action that seeks compensation when a prosthetic joint causes injury, requires unscheduled revision surgery, or fails earlier than expected. The claim can run along four parallel routes: strict product liability against the manufacturer under the Liability for Defective Products Act 1991, professional negligence against the surgeon or clinician, breach of the hospital's organisational duty of care, and breach of informed consent where a patient was not warned about a known recall risk. The four routes are not mutually exclusive. Many cases proceed against the manufacturer and the hospital at the same time, with the choice driven by what caused the harm rather than by what the patient prefers.

Who can make a hip or knee implant claim?

Three groups can bring a hip or knee implant claim in Ireland: the injured patient, a parent or guardian on behalf of a minor, and the estate or a dependant of a deceased patient. The injured patient brings it personally where capacity allows. A parent or legal guardian brings it as next friend on behalf of a minor. The estate or a dependant brings it under the Civil Liability Act 1961. A claim can also be made by patients who have not yet had revision surgery but show evidence of metallosis, elevated blood cobalt or chromium ions, or pseudotumour on MARS-MRI. The question is whether harm has occurred, not whether the device has been removed. For more on representative claims, see our pages on estate claims after death and claims for children.

How long do I have to claim?

The answer depends on which route you take, and there are two competing clocks. We call this the Two-Clock Framework. The negligence clock runs for two years from the date of knowledge. The product-liability clock under the 1991 Act runs for three years from knowledge but is capped by a ten-year longstop measured from the date the producer placed the product on the market. From 9 December 2026, a 25-year latent-injury backstop applies to new implants under the revised EU PLD. Most patients in the existing Irish DePuy cohort, implanted between 2003 and 2010, are now outside the 1991 Act longstop but may still be inside the negligence clock if knowledge came late.

The negligence clock

The negligence route uses the standard medical-negligence two-year limit and the date-of-knowledge rule. The clock starts when you knew, or could reasonably have known, that you suffered a significant injury attributable to an act or omission. For implant cases, knowledge usually crystallises when imaging or blood ion testing identifies a problem traceable to the device. Unlike in England and Wales, where the Limitation Act 1980 sets a three-year limit, Ireland applies the two-year limit set by the 1991 amendment to the Statute of Limitations 1957. See the date you knew.

What will the manufacturer argue? In date-of-knowledge cases, defendants commonly argue that media coverage of the recall, routine post-implant follow-up, or the patient's own pain symptoms started the clock years before legal advice was sought. The point of practice is that knowledge means knowledge of the link between symptom and device, not mere awareness of pain or of a recall in the abstract.

The 1991 Act clock

Section 7 of the Liability for Defective Products Act 1991^[1] sets two limitation gates. Section 7(1) gives a claimant three years from knowledge of damage, defect, and producer. Section 7(2)(a) caps the claim with a hard ten-year longstop from the date the producer placed the product on the market. The s.7(2)(a) longstop has no late-emerging-injury extension. The existing Irish DePuy ASR cohort, where most implants were placed before 2010, can no longer use the 1991 Act and must rely on negligence or hospital duty.

The 25-year backstop from 9 December 2026

The revised EU Product Liability Directive was adopted on 23 October 2024 and must be transposed by 9 December 2026. Article 17 extends the long-stop to 25 years where symptoms appear late. The 25-year window applies only to implants placed on the market on or after that date, so it protects a future cohort. See also the standard 2-year medical negligence time limit.

How does this compare to other jurisdictions? England and Wales apply a 3-year personal-injury limitation under the Limitation Act 1980, with a 10-year longstop under the Consumer Protection Act 1987. The United States runs state-by-state, with statutes of repose typically between 6 and 12 years from sale. Ireland's 25-year backstop after 9 December 2026 will be among the longest available within the EU for personal-injury product-liability claims.

Should I sue the surgeon or the manufacturer?

The answer turns on what caused the harm. We call this the Cause-of-Action Triage. Surgical-technique cases run in negligence. Design or manufacturing-defect cases run in strict liability against the producer under the 1991 Act. System failures run against the hospital. Failure-to-warn cases run as informed-consent claims. Many implant cases sue more than one defendant.

The 1991 Act route avoids the fault standard but is capped by the longstop. The negligence route extends the window via date-of-knowledge but adds the proof burden of breach. Many claimants run both, treating each as a hedge against the other.

Route 1: strict liability under the 1991 Act

The 1991 Act implements the original European Product Liability Directive in Ireland. A claimant must show the product was defective (section 5), that damage was suffered, and that the defect caused the damage. There is no need to show fault. The producer can defend on the limited section 6 grounds, including that the defect did not exist when the product was put into circulation, or that the state of scientific knowledge at the time could not have detected it. The route fits when harm flows from the device itself, such as a recalled DePuy ASR head or an Exactech polyethylene insert with oxidative degradation.

Route 2: negligence (surgeon or treating clinician)

The negligence route applies when harm arises from how a competent device was used. Mis-positioning of an acetabular cup, intra-operative damage to soft tissue, post-operative infection from a breach of standard of care, or failure to act on early post-revision symptoms are all classic negligence matrices. The standard remains the Dunne v National Maternity Hospital test. For technique-driven complaints, see orthopaedic negligence and surgical errors during your hip or knee surgery.

Route 3: hospital duty of care

The hospital owes a non-delegable organisational duty that runs in parallel with the surgeon's personal duty. Failures in implant logbook keeping, batch traceability, recall response, post-revision follow-up, and theatre infection control all sit on the hospital ledger. This route is particularly important where an implant was placed before INOR began in 2014, because the absence of register data shifts the evidential burden onto local hospital records. See private hospital negligence and hospital negligence.

Route 4: informed consent

Informed consent is a separate cause of action, not a sub-set of negligence. It applies where a patient was not adequately warned about material risks, including a known recall or known elevated revision rate. Irish law requires disclosure of material risks the patient would attach significance to, following the post-Montgomery trajectory. Common informed-consent failures involve omitted disclosure of higher revision rates for metal-on-metal designs or missing recall communications.

What if the surgeon has retired or moved abroad? The claim continues against the hospital under its non-delegable organisational duty, against the surgeon's professional indemnity insurer (typically the Medical Protection Society or Medisec) at the surgeon's last-known address, and against the manufacturer if a 1991 Act route is also live. A retired or emigrated surgeon does not extinguish the action.

The next step is to gather the evidence that supports whichever route or routes apply.

Which hip and knee implants have been recalled or withdrawn?

The implants that show up most often in Irish hip and knee implant claims are DePuy ASR (recalled 26 August 2010), DePuy Pinnacle metal liner (withdrawn 2013), Stryker Rejuvenate and ABG II (recalled 6 July 2012), Smith & Nephew R3 metal liner (recalled June 2012), Smith & Nephew BHR (withdrawn September 2015), Zimmer Durom Cup, Wright Conserve/Profemur, and the Exactech recall cluster (2021–2024). The Health Products Regulatory Authority (HPRA) publishes Field Safety Notices for each device sold in Ireland.^[8] The European Commission's Eudamed database hosts the EU-wide register. The UK MHRA medical device alerts register and the United States FDA Medical Device Recalls database both record the same device families that have shipped into Ireland. Patients should check all four registers for notices that match their implant model and lot number.

Recall status is a starting point, not the whole case. Withdrawn devices, off-recall failures, and design-defect claims that pre-date a recall can all support a 1991 Act claim if the section-5 defect test is met.

What if my device is not on the recall list? A non-recalled device can still found a 1991 Act claim if the claimant proves the device was defective within the section-5 test, which looks at the safety the public is entitled to expect. From here, the focus shifts to the medical signs that something has gone wrong.

Signs your hip or knee implant has failed

Hip implant failure signs

The most reliable hip implant failure signs are pain that worsens with weight-bearing, mechanical symptoms (clicking, squeaking, grinding), and a change in leg length. Other indicators include groin or buttock pain, swelling around the joint, instability, weakness, and foot drop. For metal-on-metal implants, blood cobalt and chromium ion levels above seven parts per billion are the typical referral threshold under HPRA and UK MHRA guidance.

Knee implant failure signs

The most common knee implant failure signs are persistent pain on weight-bearing, instability, and reduced range of motion. Patients also report swelling, grinding sensations, and stiffness that does not resolve with physiotherapy. Aseptic loosening and polyethylene wear are the leading mechanical causes of revision. For Exactech recall patients, ultra-high molecular-weight polyethylene insert oxidation is the documented mechanism.

Asymptomatic but biochemically positive (metallosis)

You can have a viable claim without obvious symptoms if blood ion testing or imaging shows metallosis or pseudotumour formation. Metallosis is the tissue damage caused by cobalt and chromium ions released as a metal-on-metal implant wears. The threshold for pre-revision claim viability is whether the medical evidence shows that damage has occurred and is attributable to the device.

What evidence do you need for an implant claim?

An implant claim turns on three evidential pillars: identifying the device, documenting the harm, and (where revision has happened) preserving the explanted device itself. Each pillar maps onto a different source.

Records, INOR and the pre-2014 traceability gap

The first task is to identify the implant make, model, size, and lot or serial number. For implants placed from 2014 onwards, the Irish National Orthopaedic Register (INOR) at the National Office of Clinical Audit holds national-level data.^[9] Unlike in England and Wales, where the National Joint Registry (NJR) has tracked replacements since 2003, Ireland's INOR only began collecting data in 2014. That leaves a substantial pre-INOR cohort, including most of the 3,300 to 3,500 Irish DePuy ASR recipients implanted 2003-2010, where patient-led record retrieval is the only route. We can request your full hospital and INOR records as part of implant identification records.

Imaging and blood metal-ion testing

The second pillar is medical evidence of harm. For metal-on-metal hips, blood cobalt and chromium ion testing combined with metal artifact reduction sequence (MARS) MRI is the standard pre-revision workup. Plain X-rays are limited because metal-ion-driven soft-tissue damage does not show on radiographs. For knee implants and modular-neck hip stems, CT imaging and the relevant blood markers are standard. We instruct expert orthopaedic and biomedical engineering reports to translate the imaging into a causation opinion.

Which experts will the case need?

Most implant cases need three expert layers working together. An orthopaedic surgeon addresses standard of care, revision causation, and prognosis. A biomedical engineer addresses device design, materials science, and explant wear analysis. An occupational therapist or vocational rehabilitation expert quantifies functional loss, future care needs, and aids and appliances. Some cases also need a forensic actuary to capitalise future losses using the Ireland-specific discount rate. Expert availability and instruction lead time often dictate when a summons can issue, which interacts with the Two-Clock Framework above.

Preserving the explanted device

Does the Injuries Resolution Board handle implant claims?

No, in most cases. Medical negligence claims are excluded from the Injuries Resolution Board (IRB) by section 3(d) of the Personal Injuries Assessment Board Act 2003^[3]. Pure product-liability claims under the 1991 Act usually go directly to the High Court because the expert evidence and quantum involved exceeds the IRB's assessment-only model. Hybrid claims that combine medical negligence with product liability also bypass the IRB. The IRB, formerly known as the Personal Injuries Assessment Board (PIAB) until 2023, retains jurisdiction over road-traffic, employer-liability, and most public-liability claims, but not the clinical-and-engineering matrix an implant case involves. From here, the question becomes how the High Court values the case if liability is established.

How much compensation can you claim?

Compensation in an Irish hip or knee implant claim has two components: general damages for pain, suffering and loss of amenity, and special damages for measurable financial loss. General damages are guided by the Personal Injuries Guidelines (2021) issued by the Judicial Council, which replaced the Book of Quantum in 2021. Awards vary case by case according to severity, prognosis, and impact on daily life.

General damages under the Personal Injuries Guidelines 2021

The Guidelines, which replaced the Book of Quantum in 2021, set bracket ranges for hip and knee injuries. Severe and permanently disabling hip injuries fall in a higher bracket. Moderate and partially recovered injuries fall in a middle bracket. Minor soft-tissue cases sit in a lower bracket. For implant cases, the relevant brackets typically include the more serious orthopaedic categories because revision surgery is itself a significant injury. In Dineen v DePuy, Mr Justice Cross awarded a total of €321,000 in respect of a recalled DePuy ASR XL hip, although the breakdown between general and special damages depended on the specific facts.

The pelvis-and-hip bracket sits in Chapter 7C of the Personal Injuries Guidelines 2021^[6], with general-damages ranges from approximately €500 for minor soft-tissue cases with full recovery within six months up to €165,000 for severe pelvis-and-hip cases with permanent disability. The Guidelines note that cases involving hip replacement where recovery has not been wholly successful tend to the top of the relevant bracket. Knee injuries sit in Chapter 7N. Awards above the High Court threshold (currently €60,000) proceed in the High Court rather than the Circuit Court.

Special damages

Special damages cover the financial loss caused by the implant failure. Standard heads in an implant case include past and future medical costs (including the revision surgery itself, where private), past and future loss of earnings, future care and assistance, aids and appliances, and travel and accommodation. Future losses are capitalised using the Ireland-specific actuarial discount rate at the time of trial. How does this compare to the old Book of Quantum? The 2021 Guidelines replaced the Book of Quantum and changed bracket ranges across most categories, so awards from before 2021 are not a reliable benchmark. For an overview of how heads of loss work together, see general and special damages.

What do recent Irish cases tell us?

Three Irish cases set the current implant-claim direction: O'Sullivan v DePuy International Ltd [2016] IEHC 684 (Cross J.), Dineen v DePuy International Ltd (Cross J., €321,000 award) on the section-5 defect test, and Galvin v Sharif & DePuy International Ltd [2025] IEHC 680 (Ferriter J.) on procedural urgency. Each addresses a different element of the claim.

O'Sullivan v DePuy [2016] IEHC 684 (Cross J.)^[12]

The first Irish DePuy judgment was delivered by Mr Justice Kevin Cross on 29 November 2016. The plaintiff, Gillian O'Sullivan, brought a defective-product claim arising from a DePuy ASR/XL metal-on-metal hip and four hip replacement surgeries. The case is the procedural template for subsequent ASR trials in Ireland and a frequently-cited Irish authority on the section 5 defect test.

Dineen v DePuy: €321,000 award and "defective product" finding

In Dineen v DePuy International Ltd, Mr Justice Cross awarded a total of €321,000 to the plaintiff in respect of a DePuy ASR XL hip implanted at Bon Secours Hospital, Tralee, Co. Kerry on 6 February 2009. The court applied the section 5 defect test under the Liability for Defective Products Act 1991 and found that the ASR/XL caused her injuries. Damages broke down as €120,000 general damages (€85,000 to date plus €35,000 into the future) and €201,000 special damages (orthopaedic review, past and future care, aids and appliances). A claim for aggravated damages was rejected.

The DePuy ASR was a "defective product" within the meaning of the 1991 Act, and its "unacceptable" failure rates caused the plaintiff to undergo two revision surgeries.

Galvin v Sharif & DePuy [2025] IEHC 680: the urgency lesson^[10]

"Special circumstances must cover the whole or at least substantially the whole of the extension period and ... the periods of special circumstance justifying the plaintiff's inaction must overlap at least to some extent."

For a wider view, see our coverage of recent Irish hip implant cases.

What does the Patient Safety Act 2023 mean for me?

From 26 September 2024, healthcare providers in Ireland must disclose specified serious patient-safety incidents to the patient or family under the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023^[4]. The Act commenced under S.I. No. 482/2024, with implementing regulations in S.I. No. 501/2024, and replaced the voluntary regime in part 4 of the Civil Liability (Amendment) Act 2017. For implant patients, an open disclosure record can anchor date-of-knowledge. The Act preserves the rule that an open-disclosure statement is not an admission of liability, although the disclosure may contain factual matter that is admissible.

What changes on 9 December 2026?

The new EU Product Liability Directive 2024/2853 must be transposed into Irish law by 9 December 2026.^[5] For implants placed on the market on or after that date, three things change. The latent-injury backstop extends from 10 years to 25 years for personal-injury claims (Article 17). Medical software, AI-driven decision support, and digital products are brought clearly within scope alongside hardware. Producer disclosure obligations strengthen, with a court-supervised duty to provide evidence about the design and risk profile of a product where the claimant has presented plausible facts. The new Directive does not retrospectively reopen claims that are already time-barred. It will, however, change the limitation calculus for the next generation of Irish implant patients.

Will I have to pay if I lose?

Most Irish solicitors handle hip and knee implant claims on a no-foal-no-fee basis, where the solicitor's professional fees are not payable if the case is unsuccessful. Outlays are different and can be payable even if the case fails. Outlays include expert reports, barristers' fees, court issue and stamp fees, and discovery costs. Adverse costs can be ordered against an unsuccessful plaintiff if the case has been pursued unreasonably or in breach of court directions. The fee structure should be set out in writing in the section 150 letter at the start of the case under section 150 of the Solicitors (Amendment) Act 1994. See no-win-no-fee for medical negligence and no-win-no-fee generally.

What to do this week

If you suspect that a hip or knee implant has caused you harm, five practical steps usually move the case forward fastest: identify the device, request your records, get the relevant imaging and biochemistry, preserve the explanted device if revision is planned, and take legal advice on the route and the clock.

1. Identify the device. Ask your hospital for the implant logbook entry showing make, model, size, and lot or serial number. Without this, no manufacturer claim can begin.
2. Request your records. Make a written request for your full hospital chart, theatre notes, and any INOR record. We can do this for you.
3. Get the relevant imaging and biochemistry. A MARS-MRI for metal-on-metal hips, or appropriate cross-sectional imaging plus blood ion testing where indicated.
4. Preserve the explant if revision is planned. Write to the consultant and pathology department before theatre asking that the device be retained.
5. Take legal advice on the route and the clock. The decision between negligence and the 1991 Act, and the date the relevant clock started, both turn on case-specific facts. See what to do this week.

Common mistakes claimants make

Six recurring errors quietly close otherwise viable hip and knee implant claims.

1. Assuming the 2-year limit applies to the manufacturer route. The negligence clock is two years. The 1991 Act clock is three years from knowledge. Confusing the two costs cases.
2. Letting the explant be discarded. Hospitals dispose of explanted devices by default after a defined window. Without the device, manufacturer experts cannot examine wear patterns and the strict-liability case weakens.
3. Waiting for revision before taking advice. Pre-revision claims rest on imaging and blood ion testing. The clock can run long before any revision is scheduled.
4. Treating the recall as the case. The section 5 "defect" test, not the regulator's recall decision, decides liability under the 1991 Act. A non-recalled device can still be defective. A recalled device still has to fail the test in the patient's own facts.
5. Issuing summons but not serving promptly. Following Galvin v Sharif & DePuy [2025] IEHC 680 the High Court has set aside renewal orders where the delay was unjustified.
6. Naming the wrong defendant. Surgeons, hospitals, and producers each owe distinct duties. Picking only one and letting limitation run on the others removes optionality.

Common questions our solicitors hear in implant cases

Themes that come up repeatedly when patients first call about a hip or knee implant.

References

How we researched this page. Statutory references are sourced from the Irish Statute Book (the Office of the Attorney General's official online text of Acts of the Oireachtas). EU directive references are sourced from EUR-Lex. Case-law references are sourced from the Courts Service judgments archive and from BAILII where the judgment is hosted. Personal Injuries Guidelines bracket figures are sourced from the Judicial Council of Ireland. Regulatory references are sourced from the Health Products Regulatory Authority and the European Commission's Eudamed database. The page is reviewed by the named author, refreshed on the date stated above, and updated whenever a new statutory commencement, primary judgment, or regulatory notice changes the answer.

1. Oireachtas of Ireland. Liability for Defective Products Act 1991, No. 28 of 1991, sections 2 (producer liability), 5 (defective product), 6 (defences), and 7 (limitation). Irish Statute Book. Available at irishstatutebook.ie/eli/1991/act/28/enacted/en/html#sec5 (last accessed 5 May 2026).
2. Oireachtas of Ireland. Statute of Limitations (Amendment) Act 1991, No. 18 of 1991, section 3 (date of knowledge for personal-injury actions). Irish Statute Book. Available at irishstatutebook.ie/eli/1991/act/18/enacted/en/html#sec3 (last accessed 5 May 2026).
3. Oireachtas of Ireland. Personal Injuries Assessment Board Act 2003, No. 46 of 2003, section 3 (excluded actions, including medical negligence). Irish Statute Book. Available at irishstatutebook.ie/eli/2003/act/46/enacted/en/html#sec3 (last accessed 5 May 2026).
4. Oireachtas of Ireland. Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023, No. 10 of 2023. Commenced by S.I. No. 482/2024 on 26 September 2024, with implementing regulations in S.I. No. 501/2024 made 1 October 2024. Irish Statute Book. Available at irishstatutebook.ie/eli/2023/act/10/enacted/en/html (last accessed 5 May 2026).
5. European Parliament and Council. Directive (EU) 2024/2853 of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC, OJ L of 18 November 2024. Article 17 (limitation, including 25-year latent-injury backstop). Transposition deadline 9 December 2026. EUR-Lex. Available at eur-lex.europa.eu/eli/dir/2024/2853/oj (last accessed 5 May 2026).
6. Judicial Council of Ireland. Personal Injuries Guidelines, adopted 6 March 2021 and effective from 24 April 2021. Chapter 7C (pelvis and hips, €500-€165,000) and Chapter 7N (knee). Available at judicialcouncil.ie/personal-injuries-guidelines/ (last accessed 5 May 2026).
7. Injuries Resolution Board. Personal Injuries Resolution Board: claim assessment process (formerly the Personal Injuries Assessment Board). Available at injuries.ie (last accessed 5 May 2026).
8. Health Products Regulatory Authority (HPRA). Field Safety Notices and medical device safety information. Available at hpra.ie/find-a-medicine/safety-notices (last accessed 5 May 2026).
9. National Office of Clinical Audit (NOCA). Irish National Orthopaedic Register (INOR), established 2014. Available at noca.ie/audits/irish-national-orthopaedic-register (last accessed 5 May 2026).
10. Ferriter J., High Court of Ireland. Galvin v Sharif & DePuy International Ltd [2025] IEHC 680, judgment of 10 December 2025. Renewal of personal-injury summons set aside under Order 8(2) of the Rules of the Superior Courts. Available at bailii.org/ie/cases/IEHC/2025/2025IEHC680.html (last accessed 5 May 2026).
11. Citizens Information Board. Medical negligence in Ireland (consumer guidance). Available at citizensinformation.ie/en/justice/civil-law/medical-negligence (last accessed 5 May 2026).
12. Cross J., High Court of Ireland. O'Sullivan v DePuy International Ltd [2016] IEHC 684, judgment of 29 November 2016. First Irish DePuy ASR substantive judgment. Available at courts.ie/judgments (last accessed 5 May 2026).
13. Health Service Executive (HSE). National Open Disclosure Policy 2025: Communicating with patients and relevant persons following patient safety or notifiable incidents. Available at hse.ie/eng/about/qavd/incident-management/open-disclosure (last accessed 5 May 2026).

Glossary of terms used on this page

Metallosis

The deposition of metal debris and tissue damage caused by cobalt and chromium ions released as a metal-on-metal hip implant wears.

MARS-MRI

Metal artifact reduction sequence magnetic resonance imaging. The standard imaging modality for assessing soft-tissue damage around metal-on-metal hip implants.

Pseudotumour

A non-cancerous mass of inflammatory tissue that can form around a failing metal-on-metal hip implant, visible on MARS-MRI.

ALVAL

Aseptic lymphocyte-dominated vasculitis-associated lesion. A histological pattern indicating an immune reaction to metal wear debris.

Aseptic loosening

Separation of the implant from the bone in the absence of infection. A leading mechanical cause of revision in hip and knee arthroplasty.

Polyethylene wear

Erosion of the polyethylene component of a knee or hip prosthesis, releasing particulate debris that can drive osteolysis (bone loss).

Revision arthroplasty

Surgery to remove and replace a previously implanted joint prosthesis. Often more complex than the primary implant.

Explant

The implant component or components removed at revision surgery. Critical real evidence in product-liability cases.

Longstop

An absolute time limit measured from a fixed starting event (here, the date the producer placed the product on the market). Unlike the date-of-knowledge limit, a longstop is not extended by late-emerging injury.

Date of knowledge

The date on which a claimant knew (or could reasonably have known) of the injury, its significance, and its connection to an act or omission. The starting point for the 2-year negligence clock.

IRB (Injuries Resolution Board)

Statutory body that assesses personal-injury claims, formerly known as the Personal Injuries Assessment Board (PIAB) until 2023. Medical negligence is excluded from its remit.

INOR (Irish National Orthopaedic Register)

National implant register hosted at the National Office of Clinical Audit. Began collecting data in 2014. The Irish counterpart of the UK National Joint Registry.

HPRA

Health Products Regulatory Authority. The Irish medical-device regulator. Publishes Field Safety Notices for devices sold in Ireland.

Field Safety Notice (FSN)

A regulator-published notice informing healthcare providers and patients of a safety issue with a specific device, sometimes accompanying a recall.

Eudamed

The European Commission's database for medical devices and related regulatory information across the EU.

Product Liability Directive (PLD)

The EU directive on liability for defective products. The 1985 Directive is implemented in Ireland by the Liability for Defective Products Act 1991. The 2024 Directive (Directive (EU) 2024/2853) replaces it from 9 December 2026.

Common questions