Clinical Trials and Clinical Investigations in Ireland

Medicinal products

In Ireland, the set up and conduct of clinical trials is primarily regulated under the EU Clinical Trials Regulation[1] , or ‘CTR’.

After a three-year transition period, the CTR became fully applicable across the EU on 31 January 2025. All clinical trials in the EU, including trials that were approved under the previous Clinical Trials Directive, are now regulated under the CTR.

The CTR is given further effect in Ireland through a suite of secondary legislation called ‘statutory instruments’ or ‘S.I.s’, namely:

• The European Union (Clinical Trials) Regulations 2022[2]. These regulations:
  • Implement the CTR
  • Set out the responsibilities of each of the stakeholders involved in the conduct of a clinical trial, and
  • Describe the powers of the relevant Irish regulatory agency, the Health Products Regulatory Authority (HPRA) at national level

• The European Union (Clinical Trials on Medicinal Products for Human Use) (National Research Ethics Committees) Regulations 2022[3]. These regulations establish:
  • The National Office for Research Ethics Committees, and
  • The National Research Ethics Committees for clinical trials (NREC).

The HPRA and the National Office, in conjunction with the NREC, are both involved in a coordinated procedure for the scientific and ethical assessment of clinical trials to be conducted in Ireland. The coordinated procedure culminates in single national decision submitted by the HPRA on a new application, both on its own behalf and on the behalf of the National Office/NREC, via the EU Clinical Trials Information System.

Related regulations such as the Medicinal Product (Control of Manufacture), Regulations 2007[4], have also been updated to account for the coming into force of the CTR, to the extent that they relate to the manufacture of investigational medicinal products, for instance.

For further information, the HPRA has published a Guide to Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland (June 2023). The Guide provides additional insights on:

• Specific regulatory requirements linked to safety reporting
• Supervision
• Archiving
• GCP inspections, and
• The manufacture and/or importation of investigational medicinal products and auxiliary medicinal products

This guidance states that the national legislation provided through the aforementioned S.I.s does not introduce requirements over and above those outlined in the CTR.

The Irish public health service, the Health Service Executive (HSE) and the Irish Pharmaceutical Healthcare Association (IPHA) have also developed and agreed a set of standard (model) bipartite, tripartite and other clinical trial agreements, referred to as 'mCTAs'. Use of these mCTAs are treated as a mandatory requirement by IPHA member companies and HSE sites.

Medical devices

In Ireland, the set up and conduct of clinical investigations are regulated under the EU Medical Devices Regulation[5] (MDR). The MDR is transposed into Irish law using the Medical Device Regulations 2021[6]. Under the MDR, there are three types of clinical investigations:

Clinical investigations conducted to demonstrate conformity of devices (Article 62 studies)

These generally involve non-CE marked devices, or CE marked devices used outside the scope of their intended purpose. Clinical investigations of this type are used to establish that a medical device is suitable for its intended purpose and to verify its clinical benefits. These investigations are also used to validate the safety of the device, determine any side-effects from its use and weigh its benefits against its risks.

Clinical investigations regarding devices bearing the CE marking (Article 74 studies)

These are clinical investigations of CE marked devices where the investigation subjects the participants to additionally invasive or burdensome procedures. The sponsor must notify the HPRA of its intention to conduct this kind of clinical investigation at least 30 days prior to its planned commencement.

Other types of clinical investigations (Article 82 studies)

These include all other kinds of clinical investigations. These clinical investigations must adhere to the requirements listed in Article 14 of the MDR, including having a legal representative in Ireland and ensuring certain rights and protections for the subjects participating in the investigation. The sponsor must notify the HPRA of its intention to conduct this kind of clinical investigation at least 30 days prior to its commencement.

In Ireland, all clinical investigations must receive ethics approval from the National Research Ethics Committee – Medical Devices (NREC-MD) before they begin. This ethics review is separate to the authorisation process administered by the HPRA. Applications concerning the same clinical investigation can be made to the NREC-MD and to the HPRA at the same time or at different times. That said, however, the clinical investigation cannot start until both reviews are complete.

For further information, the HPRA has published a Guide to Clinical Investigations Carried Out in Ireland (May 2024). The guidance offers additional insights on:

• Specific regulatory requirements linked to the various types of clinical investigation
• Application processes and the reporting of modifications to approved clinical investigations, and
• Adverse event and device deficiency reporting

In vitro diagnostic medical devices (IVDs)

Similar to medical devices, the set up and conduct of performance studies concerning IVDs are regulated under In Vitro Diagnostic Regulation[7] (IVDR). The IVDR is transposed into Irish law using the In Vitro Diagnostic Medical Devices Regulations 2022[8].

Various types of performance studies, as defined under the IVDR, conducted in Ireland require either an application or a notification to the HPRA. Performance studies are considered to be conducted in Ireland in cases where:

• The site is based in Ireland, or
• Participants/specimens originate from Ireland

Additional information is provided by the HPRA through its Guide to Performance Studies Conducted in Ireland (June 2022). The guidance provides further insights on specific regulatory requirements linked to the various types of performance study, application processes and the reporting of adverse events.

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The content of this article is provided for information purposes only and does not constitute legal or other advice.

[1] Regulation (EU) 536/2014

[2] S.I. No 99/2022

[3] S.I. No 41/2022

[4] S.I. No 539/2007

[5] Regulation (EU) 2017/745

[6] S.I. No 261/2021

[7] Regulation (EU) 2017/746

[8] S.I. No 256/2022