‘Procedure pack’ is defined as a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose, cf. MDR Article 2 (10)
‘System’ is defined as a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose, cf. MDR Article 2 (11)
What can a system and procedure pack contain?
- Medical devices bearing the CE marking (IVD and MU)
- Other products that meet the requirements of the regulations that apply to these products
Some examples: First aid kit, orthodontic procedure kits, catheterisation kits, wound change kits, (procedure pack), X-ray systems (system)
A statement shall be prepared by the person who places the device on the market as a system or a procedure pack, which shall contain a declaration of the following:
- They have checked that the device and other products are compatible with each other in accordance with the manufacturer's instructions, and have carried out their activities in accordance with those instructions.
- They have packaged the system or procedure pack and provided the users with relevant information. This includes information from the manufacturers of the devices or other products that have been combined.
- The activity of combining devices and other products as a system or procedure pack has been subject to internal monitoring, verification and validation methods.
- If systems or procedure packs are sterilised, the sterilisation was carried out in accordance with the manufacturer's instructions.
When sterilising systems or procedure packs, one of the procedures set out in Annex IX or Part A of Annex XI shall be used. The use of these procedures and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged.
The declaration must be available to the competent authorities after the system or procedure packs have been combined. This applies for at least ten years after the last device has been sold, and at least 15 years for implantable devices.
When should the natural or legal person assembling a system or procedure pack assume the obligations on manufacturers?
- If the system or procedure pack contains devices that do not bear the CE marking
- If the chosen combination of devices is not compatible with the original intended purpose of the devices
- If the sterilisation has not been carried out in accordance with the manufacturer's instructions
The natural or legal person assembling the system or procedure pack is then to be regarded as the manufacturer, and the devices shall be subject to the relevant conformity assessment procedure of Article 52 of the MDR.
Requirements for labelling a system or procedure pack
- The devices shall not themselves bear an additional CE marking
- The label shall contain the name, registered trade name or registered trade mark of those who combined the system or procedure pack
- The label shall state the address where the natural or legal person can be contacted
- The label shall contain the information described in MDR Annex I (23) and/or IVDR Annex I (20)
- On the outside of the packaging both UDI-DI and UDI-PI shall, as a general rule, be affixed cf. Annex VI, part C (6.3.3.)
- The expiry date shall be based on the shelf life of the component with the shortest shelf life
- The system or procedure pack must be labelled with a specific lot number
- The label must contain information on the packaging that maintains any sterile condition of the device
- Information supplied with the system or procedure pack must contain a list of components and must be found either in the declaration, on the label or in the instructions for use.
Registration and traceability of a system or procedure pack
The person who assembles a system or procedure pack is to be regarded as an economic operator and must apply for a single registration number (SRN). The economic operator must assign the system or procedure pack a basic UDI-DI. In addition, the information must be registered in the UDI database (Eudamed), cf. MDR article 29 (2). For more information on traceability and registration of system and procedure packs, see the guide MDCG 2018-3.
Procedure for dealing with a system or procedure pack that poses an unacceptable risk to health and safety
If this is the case, the economic operator shall without delay ensure that all appropriate corrective action is taken throughout the EU / EEA for all affected devices that they have made available on the market, cf. MDR Article 95 (3).