Systems & Procedure Packs (KITS)

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 (usually 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 and 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;

Step 2:

  • 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).

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