Definition: Procedure Pack
(10) ‘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;
Definition: System
(11) ‘system’ means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose;
Procedure Packs But Not Systems
Examples of combinations of products that are procedure packs but not systems:
- Blood pressure monitor marketed in a pack together with a suitable disinfectant
- Infusion pumps (medical device) and software for controlling infusion pump parameters (accessory) that are marketed together in one pack
Procedure Packs and Systems
Examples of combinations of products that are both systems and procedure packs:
- Electrosurgery devices marketed in a pack together with high-frequency electrodes
- Implants marketed in a pack together with bone cement
- Syringe pumps marketed in a pack together with disposable syringes
Systems But Not Procedure Packs
Examples of combinations of products that are systems but not procedure packs:
- All of the above examples if the products are sold individually but should be/are combined (in line with the intended purpose)
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