Ireland: Medical Device | Registration | Process

Ireland is one of the top the 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.

Health Products Regulatory Authority (HPRA) (formerly the Irish Medicines Board).

European Medicines Agency (EMA).

Environmental Protection Agency (EPA). 

Health Products Regulatory Authority (HPRA): 

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

Step 2: Product Registration

Step 3: HPRA document verification

Step 1: Organization Registration:

There are two way to registration:

1st: Online Mode

You can register for HPRA on their website with respective fees.

2nd: Manual Mode

In this case you need to download the form 'Publication and Forms 'section of http://www.hpra.ie then filled it and also attached required attachment and submit to HPRA.

Step 2: Product Registration:

The Product Registration is online process for that you have to go on    https://access.medicaldevices.ie and login with the help registration id and password of HPRA. After that you have to fill all product related information and take print out of it.

(Important note: Kindly provide Global Medical Device Nomenclature system (GMDN) for medical device which is to register during the registration. You can contact to GMDN agency through their contact details present in their website if GMDN is not available for particular device for nomenclature.)

Documents attached:

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 required:

a.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 )

b.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 )

c-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 .

d.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)