Systems & Procedure Packs (KITS)
The Medical Device Regulation (article 22) refers to some specific ways in packing devices together while placing them on the market:
‘procedure pack’ or 'kit' means a combination of products (from different manufacturers) packaged together and placed on the market to be used for a specific medical purpose
‘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;
If you combine devices bearing a CE marking with another device bearing the CE marking, or an IVD bearing the CE marking, or other products for medical purpose which are in conformity with legislation, you will need
- to verify the compatibility between the devices in accordance with the manufacturers’ instructions,
- include manufacturers’ instructions in the system/procedure package, and,
- ensure the activity of combining devices and if applicable other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation,
- draw up a statement.
If you sterilize systems or procedure packs in order to place them on the market you must apply a conformity assessment procedure (Annex IX or Part A of Annex XI), involve a NB certificate for the aspects of the procedure relating to ensuring sterility and draw-up a statement that sterilization has been carried out in accordance with manufacturers' instructions..
These systems or procedure packs shall not themselves bear an additional CE marking but they shall bear the name, and address of the procedure/system “packer”.
Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination is not compatible in view of their original intended purpose, or where the sterilization has not been carried out in accordance with the manufacturer instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 12.
The statements shall be kept at the disposal of the competent authorities for 10-15 years.
Basic UDI-DI are required for systems and procedure packs.
Steps to place a kit on the EU market:
Step 1: Non-EU Manufacturer appointing an Authorized Representative in Europe;
- Manufacturer drawing a Statement (article 22)
- Label and instruction for use (Annex I – Section 23)
- NB if sterilization (statement of sterilization)
Step 3: Registration to the EUDAMED, assignment of Basic UDI-DI and UDI-DI (article 22 and 29).
- The Regulation: MDR 2017/745
- Technical File
- Notified Bodies
- Authorized Representatives
- Custom Made Devices
- Clinical Evaluation & Clinical Investigation
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