System and procedure pack producers
What is a system and procedure pack producer?
A system or procedure pack producer is a natural or legal person who places systems or procedure packs on the EU market.
‘System’ means a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose. Examples of systems include diagnostic equipment such as X ray systems or CT scan systems.
‘Procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose. Examples of procedure packs include first aid kits, orthodontic procedure packs and wound exchange kits.
How do I register as a system and procedure pack producer?
System and procedure pack producers established in Ireland must register their organisation and device details on Eudamed.
To register organisation and device details, you can login or create an account on the Eudamed landing page.
For more information on how to register organisation details, please see the Eudamed actor registration module.
For more information on how to register device details please see the Eudamed device registration module.