Ireland Medical Device Registration Process
Ireland is one of the top medical device exporters in Europe.
The medicines, healthcare diagnosis product, prevention, other product used in healthcare by providers and patients, in-vitro diagnostic (IVD) test kits, reagents, laboratory analyzers and related software, etc. is comes under the medical devices.
Regulatory Authorities in Ireland
Health Products Regulatory Authority (HPRA) (formerly the Irish Medicines Board): It is an European authority body responsible for regulation and authorization for Medical Device.
European Medicines Agency (EMA): Every single medicinal products for human utilize is derived from biotechnology and other high-technology processes must be centrally approved by the EMA.
Environmental Protection Agency (EPA): In Ireland, for the implementation of regulations on the contained use or deliberate release of genetically modified organisms (GMOs), EPA is responsible.
Registration Procedure
Step 1: Organization Registration
There are two ways to registration:
- Online Mode: You can register for HPRA on their website with respective fees.
- Manual Mode: Download the form from the 'Publication and Forms' section of http://www.hpra.ie, fill it, attach required documents and submit to HPRA.
Step 2: Product Registration
The Product Registration is online process at https://access.medicaldevices.ie. Login with your HPRA registration ID and password, fill all product related information and take print out of it.
Important note: Provide Global Medical Device Nomenclature system (GMDN) for medical device during registration. Contact GMDN agency through their website if GMDN is not available for your particular device.
Required Documents
If you are the authorized representative making application on behalf of a manufacturer then you need "Notarized Letter of designation from the manufacturer."
Class-wise document requirements:
- For Class I: EC declaration of conformity and technical documentation (Reference Directive 93/42/EEC: Article 11(5) and Annex VII part 3 S.I. No. 252 of 1994: Article 7 and Schedule 7)
- Custom-made general medical device: Documentation A statement and documentation allowing an understanding of the design (Reference Directive 93/42/EEC: Article 11(6) and Annex VIII S.I. No. 252 of 1994: Article 15 and Schedule 8)
- System or Procedure Packs: Documentation EC declaration of conformity and technical documentation (Reference Directive 93/42/EEC: Article 12 S.I. No. 252 of 1994: Article 11)
- Custom-made Active Implantable: Documentation A statement and documentation allowing an understanding of the design (Reference Directive 90/385/EEC: Article 9(2) and Annex 6 I. No. 254 of 1994: Article (9)1 and Schedule)
