The requirements related to system and procedure packs are listed in the article 22 of EU MDR 2017/745. In this article, we are going to discuss the main requirements related to the management of system and procedure packs and the implementation of these requirements from a practical point of view.
The concept of system and procedure packs is directly link with other topics that have already been extensively discussed in our website, such as the UDI system and the obligation of economic operators.
Some definitions
Before starting with the discussion of the specific requirements, let’s report some definitions that will be important to better define the context of the discussion.
Procedure Pack (or kit): a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.
System: ‘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
Procedure Pack Producer: natural or legal person who places the PP on the market (as per MDR). It is important remind that, according to MDCG 2018-03, the Procedure Pack Producer is defined as an economic operator.
Requirements for Management of Systems and Procedure Packs
Medical devices bearing a CE marking may be combined together “in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers”, in order to be placed on the market as a system pack. For doing so, the natural or legal person performing this action shall draw up a statement declaring that:
- Compatibility between the devices have been verified
- Appropriate information for user has been included in the pack
- Internal monitoring, verification and validation activities have been implemented in relation to the specific combination of devices:
The type of devices that it is possible to combine together are:
- Other devices bearing the CE marking;
- In vitro diagnostic medical devices bearing the CE marking in conformity with EU IVDR 2017/746;
- Other products, even non-medical devices, which are in conformity with legislation that applies to those products. However, this is possible only where these products are used within a medical procedure or their presence in the system or procedure pack is properly justified.
Conformity Assessment
The natural or legal person that performs sterilization of the systems or procedure packs shall be certified as per Annex IX (Conformity assessment based on a quality management system and on technical documentation) or Part A of Annex XI (Production Quality Assurance). The application of those 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. Moreover, a statement to declare that the srterilization process has been carried out in accordance with the manufacturer’s instructions shall be drafted by the sterilizer.
There are situations where the system or procedure pack shall be treated as a device in its own right and shall be subject to a standard conformity assessment as per Article 52 of the EU MDR. These situations are:
- If the system or procedure pack contains devices which do not have the CE marking;
- If sterilization has not been performed according to manufacturer’s instructions;
- If the chosen combination of devices is not compatible in view of their original intended purpose.
Registration and UDI requirements for Systems and Procedure Packs
The system or procedure pack producer shall apply for registration as a system or procedure pack producer and obtain an SRN. Moreover, UDI registration is fully applicable for system and procedure pack.
Specifically, in relation to UDI, the Basic UDI-DI shall identify systems or procedure packs having the same group of components and the same intended purpose, regardless of the original components manufacturers.
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- Source: https://www.qualitymeddev.com/2022/11/26/systems-and-procedure-packs/