Annual Technical File Maintenence Service
We take care of your Technical File throughtout the year ready for inspection any time for unannounced audits and customer audits.
Systems and Procedure Packs for CE Marking
The EU MDR 2017/745 defines about Systems and Procedure Packs in Article 22. Both “Systems” and “Procedure Packs” have been defined in the MDR as follows:
The need of a Statement for Systems and Procedure Packs
If natural or legal persons combine devices bearing CE marking with other devices bearing CE marking or IVDs bearing CE marking as per IVDR 2017/746 or other products which are in conformity with the EU legislation, must draw up a statement declaring that:
- they verified the mutual compatibility of the products and followed the instructions of the manufacturers and carried out their procedures in accordance with those instructions;
- they packaged the system or procedure pack and provided users with relevant information incorporating the information to be provided by the manufacturers of the devices or other products that were put together;
- appropriate methods of internal monitoring, verification and validation were used for the activity of combining devices and, where applicable, other products as a system or procedure pack.
What if the systems and procedure packs need to be sterilized?
If a natural or legal person sterilizes the system and procedure pack (kits) for the purpose of placing them on the market they must follow the conformity procedure (Annex IX OR the procedure set out in Part A of Annex XI). The NB involvement will be limited to aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged. The natural or legal person should also make a statement declaring that the sterilization was carried out in accordance with the instructions of the manufacturer.
What if the systems and procedure packs have devices which do not bear CE Marking?
If the systems and procedure pack (kits) includes devices which do not bear CE Marking or the chosen combination is not compatible with the intended purpose or if the sterilization has not been carried out as per the manufacturer’s instructions, the system/procedure pack will be treated as a device in its own right and should be subjected to the conformity assessment procedure as per Article 52. The natural or legal person should assume the obligations necessary for manufacturers.
General Information on System and Procedure Packs
- The systems and procedure pack shall not bear an additional CE mark on their own, but shall bear the name, registered trade name or registered trademark of the person referred to, as well as the address at which that person may be contacted so that the location of the person may be established.
- The statement should be at the disposal of the Competent Authority for about 10-15 years.
- The system and procedure pack must have a label and Instructions for Use per Annex I sec: 23.
- The natural or legal person must assign a basic UDI-DI in compliance with the issuing entity and provide it to the UDI database together with other core data elements associated with the system/procedure pack.
Steps to place Systems and Procedure Packs on EU Market
- Prepare Technical File including with all supporting evidences in line with MDR requirments.
- Add the name and address of the “packer/assembler” on the system/procedure pack
- Appoint EU Representative (For Non-EU assembler/packer)
- Drawn the declaration statement (DOC)
- Implement labels and IFUs
- NB involvement (sterility aspect)
- Receive CE Certificate from Notified Body
- Registration to the UDI database, assignment of basic UDI-DI