Ireland Medical Device Registration

Regulatory Authority

Health Products Regulatory Authority (HPRA)

The Health Products Regulatory Authority (HPRA) regulates medicines and devices for human and animal health, focusing on excellence through science, collaboration, and innovation. Their functions include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood components, tissues, cells, and cosmetic products.

Link for Regulatory Authority

http://www.hpra.ie/homepage/medical-devices/registration 

Local Regulation

Regulation (EU) 2017/745

https://www.hpra.ie/homepage/about-us/legislation

Classification of Medical Device

Class I, IIa, IIb and III 

Listing or Registration Requirements

Registration is mandatory for manufacturer located in Ireland. 

Documents Required

• A general description of the product, including any variants planned and its intended use(s);
• Design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits;
• The descriptions and explanations necessary to understand the above-mentioned drawings and diagrams and the operations of the product;
• Results of the risk analysis and a list of the harmonized standards, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements;
• In the case of products placed on the market in a sterile condition, description of the methods used and the validation report;
• The results of the design calculations and of the inspections carried out;
• The solutions adopted to ensure that the design and construction conform to safety principles;
• The pre-clinical evaluation;
• The clinical evaluation in accordance with Annex X;
• The label and instructions for use. 

Registration Timeline

The registration process takes about 4-6 weeks after submission for

• Class I devices- 4-6 weeks
• For the other classes, it depends on the contract with the notified body and the type of device. 

Registration Fee

• Registration Fee: €140
• Annual Fee for manufacture located in Ireland (varies depending on the number of employees) – € 30,600 to € 250
• Annual Fee for Authorized Representatives (varies depending upon class of the device) – € 1,500 to € 1,100
• Annual Fee for Distributors and Importers varies from – € 4,590 to € 250 

License Validity: 

Special Labelling Requirements

Medical devices placed on the Ireland market must have a UKCA marking or a CE marking, depending on which legislation the device has been certified under. Where relevant, the number of the Approved Body or Notified Body must also appear on the label. 

Additional Comments

If you have a registered place of business in Ireland (Manufacturers or local Authorized representatives) 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,
• Sterilize, 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 devices on the market within the above-listed categories.

Who should make this Communication?

• Manufacturer
• Importers
• Distributors
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk