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. 

Organisation details must be registered via the Eudamed actor registration module. 

Device details must be registered via the Eudamed device registration module.