Medical Device Registration in Ireland
Ireland is an island in the North Atlantic. It is the island separated from Great Britain to its east by the North Channel, the Irish Sea, and St George’s Channel. Ireland is the third-largest island in Europe. Although Ireland’s economy is strong compared to its European neighbors, the medical device market will grow modestly over the next few years. The Irish market was valued at the US $.72 billion in 2016 and will increase to $.83 billion by 2020. The medical device manufacturing industry in Ireland is robust. In fact, many of the top medical device companies have operations in Ireland. However, the domestic manufacturing industry is based on exports; Ireland is one of the top medical device exporters in Europe.
The term medical device covers a very wide range of products, excluding medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or handicap and includes many thousands of items used each day by healthcare providers and patients. It also includes in-vitro diagnostic (IVD) test kits, reagents, laboratory analyzers and related software, etc.
The national regulatory authority agencies responsible for the regulation of medical products in Ireland are:
- Health Products Regulatory Authority (HPRA) (formerly the Irish Medicines Board).
- European Medicines Agency (EMA).
- Environmental Protection Agency (EPA).
The HPRA(Health Products Regulatory Authority) is the national competent authority responsible for, among other things, the:
- Regulation of medical devices and cosmetic products.
- The authorisation of medicinal products.
- Monitoring of the quality, manufacturing, and distribution of medicinal products.
- Implementation of EU and national legislation relating to blood, blood components, tissues, and cells.
- Monitoring the safety of medical devices in Ireland after they are placed on the market.
- To designate and continuously monitor the performance of the Irish Notified Body which must have the capability to assess and approve specific medical devices.
- Operate a national reporting system for medical devices.
- Carry out on-site audits of selected manufacturers of medical devices to monitor compliance with relevant standards and legislation.
Combination products (Products that are therapeutic and diagnostic products that combine drugs, devices, and/or biological products) are regulated by the HPRA under medical devices legislation. These products are subject to high levels of compliance assessment and classified as class III (highest risk) devices.
All medicinal products for human use derived from biotechnology and other high-technology processes must be centrally approved by the EMA.
The EPA is the competent authority responsible for the implementation of regulations on the contained use or deliberate release of genetically modified organisms (GMOs) in Ireland.
Medical Devices Legislation
The Irish Medicines Board (i.e IMB) is the competent authority for the regulation of medical devices on the Irish market, being the competent authority appointed under the Medical Devices Legislation. The IMB serves to ensure that all such devices which are placed on the market in Ireland meet the essential requirements of the Medical Devices Legislation.
There are three types of medical devices outlined in the legislation. They are as follows:
- General medical devices
- active implantable medical devices
- in-vitro diagnostic medical device.
Medical devices are divided into classes dependent on risk which can be low, medium and high risk.
The scope of medical device regulation also includes in vitro diagnostic (IVD) medical devices. An IVD medical device includes any medical device (such as a reagent, reagent product, calibrator, control material, instrument, apparatus) that is used alone or in combination and that is intended by the manufacturer to be used in vitro to provide information on, for example, a physiological or pathological state or to monitor therapeutic measures. These include pregnancy test kits, urinalysis test strips and specimen receptacles (such as blood collection tubes).
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-vitrodiagnostic 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 sterilized before use,
- Are the designated European authorized 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
Registration of person responsible for placing medical device in Ireland Market
- If you have a registered place of business in Ireland you must register with the HPRA.
- If you do not have a registered place of business in a Member State you must designate a single authorized representative in the European Union to act on behalf of the manufacturer.
- First Step: Registration of Organization
- Second Step: Registration of Medical Device
- Third Step: Document review by HPRA
How can I register?
Step 1: Registration of Organization
Mode of Registration is done in two ways:
Mode -1: Online Mode
Online registration with HPRA is to be done on www.hpra.ie (for the medical device) with requisite fees.
The flow of the Online Process goes as per the below image:
Steps involved during registration of Organization:
Step 1: Organization Details
Step 2: Contact Details
Step 3: Condition of Use
Mode -2: Manual Mode
The form to be downloaded from ‘Publication and Forms ‘section of www.hpra.ie (for the medical device) is to be filled and attached with supporting documents, requisite fees to submit to HPRA.
(If registering as an authorized representative then attach the Notarized letter of designation represents evidence of designation by the manufacturer)
Step 2: Registration of Medical Device
Registration of device is to be made online on https://access.medicaldevices.ie with the help of Username and Password issued by the HPRA, after the successful filling of device details, take the printout of it.
(Note: During registration of a medical device, kindly provide Global Medical Device Nomenclature system (GMDN) for a medical device which is to register. If GMDN is not available for a particular device, then contact to GMDN agency for nomenclature. Details can be seen on the GMDN agency website)
Documents to be attached with the application:
- Notarized Letter of designation from the manufacturer if you are the authorized representative making
application on behalf of a manufacturer
- Documents requires for review to the competent authority ( Class wise ):
- Class I Documentation 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)
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