Why do I need
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.
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.
- Are a manufacturer or authorised representative relocating to Ireland as a result of Brexit.
New EU Medical Device Regulations Registration
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 . Guidance on registration under the new Regulations will be provided in due course.
Registrations impacted by Brexit
At the end of March 2019 the UK will leave the European Union and become a ‘third country’ unless a ratified withdrawal agreement establishes another date. In January 2018 the European Commission published a notice to all stakeholders outlining the impact this will have for industrial products including medical devices.
Organisations establishing in Ireland as a result of Brexit may register using our on-line system as a legal manufacturer or authorised representative provided the following conditions are met:
- An entity has established in Ireland
- A written mandate is in place between the Manufacturer the outgoing UK based legal Manufacturer/ Authorised Representative and the new incoming Irish based legal manufacturer/ Authorised Representative
The mandate should include the following:
- Date of termination of the mandate of the out-going legal manufacturer/ authorised representative (if changing AR),
- Date of the beginning of the mandate of the incoming legal manufacturer/ authorised representative (if applicable),
- Roles and responsibilities of the parties called out in the mandate during transfer,
- Details of the establishment of the incoming legal manufacturer/ authorised representative in Ireland,
- Plan for transition and date for completion of labelling/packaging/IFU (and promotional material) updates to identify the incoming legal manufacturer/ authorised representative,
- Details of how any complaints/ reports/incidents will be managed during the transfer and how the system’s effectiveness will be monitored by the legal manufacturer/ authorised representative.
Further guidance on Brexit will be provided to medical device stakeholders in due course.
If you intend on registering with the HPRA as a result of Brexit please contact email@example.com for further details on the HPRA’s registration process before submitting organisational details online.
How can I register?
You can register with the HPRA online by submitting the relevant information through the medical devices Extranet.
The initial administrative fee as well as the ‘Registration Terms & Conditions’ document must be signed and returned to the HPRA.
If you are an authorised representative acting on behalf of a manufacturer a notarised letter of designation must also be submitted.
A ‘Medical device registration system user name and password conditions of use’ form must then be signed and returned to the HPRA. Once received, a username and password will be sent to you. Once registered, organisations can update contact and device details using their extranet account.
All documentation should be submitted, where possible, electronically e.g. signed documents can be scanned and submitted in pdf format.
Further information on the Extranet system is included in our guidance document for using the on-line device registration system.
Registration Documentation Checklist:[SD1]
- Administration fee paid
- Signed Registration Terms and Conditions Document
- Signed Username and password conditions of use document
- If registering as an Authorised Representative
- A Manufacturers notarised letter of designation
- If Brexit related – a written mandate and transition plan
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 Medical Devices Department at firstname.lastname@example.org.