“Systems” or “Procedure Packs” (MDD 93/42/EEC Article 12);
A “procedure pack” can be defined as an assembly of medical devices that are packed together and sold on the market with the intention of being used during procedures (e.g., surgical procedure) or medical treatment.
The devices in the “procedure pack” are not required to be used in combination or at the same time. Moreover, the manufacturer of the procedure pack may be the manufacturer of all the devices from the procedure pack, or may put in the procedure pack devices having different manufacturers.
Example of procedure packs:
- First aid kits;
- Packs for specific surgical procedure;
- Orthodontic procedure packs.
A “system” can be defined as an assembly of medical devices that are designed to be used solely in combination one with the other, and cannot achieve the claimed medical intended purpose alone (see scope of a medical device).
Example of systems:
- Prosthetic system;
- Joint replacement system.
Please note that a “system” or “procedure pack” (KITs) comprising medical devices, all devices must undergo individual conformity assessment procedures and bear the CE marking individually while the KIT itself will not be CE marked;
Steps to place a KITS on the EU market
Non-EU Manufacturer appointing an Authorized Representative in Europe;