Who Regulates Medical Devices in Ireland?

The Health Products Regulatory Authority (HPRA) is the competent national authority in Ireland. It is responsible for ensuring that medical devices in the Irish market comply with European Union legislation.

HPRA does not issue CE marking certifications, but:

• Supervises manufacturers based in Ireland;

• Performs inspections;

• And it tracks incidents related to device security.

HPRA official website:

Https://www.hpra.ie

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Applicable Legislation

The legislation governing medical devices in Ireland is based on European regulations:

• Regulation (EU) 2017/745 (MDR): For medical devices in general

• Regulation (EU) 2017/746 (IVDR): For medical devices for in vitro diagnosis

These regulations replaced the old European directives (MDD/IVDD) and raised the level of demand in terms of safety, clinical evidence and traceability.

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Quick Example: Who Needs Approval?

• Company A has developed a wearable sensor that monitors heart rate - needs CE marking and technical submission.

• Company B imports sterile syringes from the US for resale - it needs to be registered with EUDAMED and notify the HPRA.

• Company C manufactures an application that helps in the diagnosis of diseases - it can be classified as medical software and also needs regulatory evaluation.

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Step by Step of Submission for Approval

1. Classify your device

Risk-based classification (Class I, IIa, IIb, III). The higher the risk, the more rigourous the assessment will be.

• Class I: Low-risk devices (e.g. dressings, reading glasses)

• Class IIa/IIb: Medium to high risk (e.g. syringes, infusion pumps)

• Class III: High risk (e.g. heart valves, stents)

MDR - HPRA Classification Guide (PDF)

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2. Create the Technical Documentation

Includes:

• Information on design and manufacturing;

• Clinical evaluation;

• Risk management;

• Tests and validations.

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3. Implement a Quality Management System (QMS)

ISO 13485 is the most accepted international standard for medical device manufacturers.

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4. Go through a Notified Organisation (if necessary)

For class IIa, IIb and III devices, you must hire a Notified Body to review your documentation and issue the CE certificate.

Example of a Notified Organisation operating in Ireland:

•NSAI (National Standards Authority of Ireland): https://www.nsai.ie

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5. Register with EUDAMED

All manufacturers, importers and representatives must register on the EUDAMED platform to obtain the SRN (Single Registration Number).

EUDAMED - Official website of the European Commission

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6. Notify the HPRA

If your company is based in Ireland, you must:

• Notify the HPRA about the device placed on the market;

• Report any serious incident or recall;

• Be available for periodic inspections.

Forms and notifications - HPRA

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Final Tip: Invest in Specialised Support

European legislation is detailed and constantly updated. To avoid delays or refusals, many companies choose to:

• Hire regulatory consultants;

• Use authorised representatives with experience in EUDAMED and MDR;

• Participate in HPRA pre-submission programs and webinars.

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Conclusion

Complying with medical device legislation in Ireland is a technical process, but feasible with planning. The CE marking opens doors not only to the Irish market, but to the entire European Union.

If you are thinking of launching a medical device on the European market, starting with Ireland can be an excellent strategy — especially with the right support from the start.

Regulatory Checklist: