CE Marking of Systems and Procedure Packs

CE Marking of Systems and Procedure Packs

MDR 2017 article 22 details about the requirments and methods to be adopted for CE Marking of medical devices condidered as "Systems" or "Procedure Packs"

The following must be considered before planning for CE Marking"

  1. Status of each component(s) for CE Certification
  2. System or procedure pack justification
  3. Compatibility of the devices
  4. The natural or legal person statement declaring that sterilisation has been carried out in accordance with the each component manufacturer's instructions.

System means either packaged together or not which are intended to be inter-connected or combined to achieve a specific intended purpose. E.g. X-ray system

Whereas, 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. E.g.: First aid kit, orthodontic procedure packs etc.

Article 22 of MDR states that the natural or legal persons who combine medical devices bearing a CE marking alone or together with other products which are not devices and are compliant with the respective legislation which apply to them, who place that combination on the market as either a system or a procedure pack that is intended to achieve a specific medical purpose. It shall not bear an addition CE marking. They might place the system or procedure pack on market with the below statements as applicable

  1. Other devices bearing CE marking
  2. Invitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746
  3. Other products which are in conformity with legislation where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified

The Producers at the disposal of the competent authorities, after the system or procedure pack has been put together must declare that

  1. They have verified the mutual compatibility of the devices and if applicable, other product with IFU
  2. They have packaged the systems or the procedure with adequate supply of user instructions about the devices that have been put together
  3. Appropriate validation, monitoring and verification have done on the activity of combining devices.

If the legal person sterilizes the system or procedure pack before placing in market, then the conformity assessment should be based on the Annex IX or part A of Annex XI provided its application the involvement of the notified body will be limited to the ensuring the sterility until the sterile packaging is opened or damaged. The legal person has to declare that the sterilization process has been carried out in accordance with the manufacturer's instructions.

If the system or procedure pack with any of the following three conditions shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure followed for that medical device classification as per the Article 52 of MDR

  • Incorporates devices which do not bear the CE marking, OR,
  • The chosen combination of devices is not compatible in view of their original intended purpose, or
  • The sterilisation has not been carried out in accordance with the manufacturer's instructions, the system or procedure packs.

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