Why do I need to register?
Article 14 of Directive 93/42/EEC (Regulation 14 of the National legislation, S.I. 252 of 1994) and Article 10 of the IVD Directive, 98/79/EEC, (Regulation 10 of the National legislation, S.I. 304 of 2001) require that certain persons placing devices on the market must register their contact details and details of their device(s) with the Competent Authority in the Member State where they have their registered place of business.
Note: The new EU medical device Regulations entered into force in May 2017. The medical devices Regulation has a three year transition period and is fully applicable from 26th May 2020. The in-vitro diagnostic medical device Regulation has a five year transition period and is fully applicable from 26 May 2022.
If you intend on registering medical devices compliant with the new Regulations during the transition period please contact firstname.lastname@example.org or email@example.com . Guidance on registration under the new Regulations will be provided in due course
Who needs to register?
If you have a registered place of business in the Republic of Ireland you must register with the HPRA if you:
- manufacture class I or custom made medical devices and place them on the market under your own name, or trading name(s),
- manufacture custom made active implantable medical devices and place them on the market under your own name, or trading name(s),
- manufacture in-vitro diagnostic medical devices and place them on the market under your own name, or trading name(s),
- fully refurbish class I devices, or label one or more ready-made devices, with a view to placing these on the market under your own name,
- place medical devices bearing the CE marking on the market, in a system or a procedure pack,
- sterilise, for the purpose of placing on the market, systems or procedure packs or other CE marked medical devices designed by the manufacturers to be sterilised before use,
- are the designated European authorised representative for a manufacturer who does not have a registered place of business in the European community, and who places on the market devices within the above-listed categories
How can I register?
You can register with the HPRA online by submitting the relevant information through the medical devices Extranet.
A ‘Medical device registration system user name and password conditions of use’ form must then be signed and returned to the HPRA along with the applicable payment and, if you are an authorised representative acting on behalf of a manufacturer, the notarised letter of designation.Documentation should be submitted, where possible, electronically e.g. signed documents can be scanned and submitted in pdf format. Once received, a username and password will be sent to you.
Once registered, organisations can update contact and device details using their extranet account. Further information on the Extranet system is included in our guidance document for using the on-line device registration system.
Note: If you do not have online access, it is possible to register manually using the applicable form below:
How much does it cost?
An initial administration fee must be paid when registering with the HPRA. There is a yearly maintenance fee for registered organisations. Please refer to the following for a guide to relevant fee codes and payment instructions:
Registration Guidance Documents
For further guidance on the requirements to register with the HPRA and the registration process please refer to the following documents:
If you would like to know more information about registration please contact the Human Products Authorisation and Registration Department at firstname.lastname@example.org.