Under Article 2 of the MDR, a “system” is a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose, while a “procedure pack” is a combination of products packaged together and placed on the market to be used for a specific medical purpose, in a manner consistent with this purpose and within the limits specified by their respective manufacturers.
Both systems and procedure packs can include a combination of CE-marked medical devices and IVDs, as well as other products which are in conformity with EU legislation that applies only to where they are used within a medical procedure or their presence in the system and procedure pack is otherwise justified.
Requirements for EU system and procedure packs under the MDR
Natural or legal persons that combine such products (i.e. “system or procedure pack producers”), to place them on the EU market as a system and procedure, must comply with several requirements established under the MDR. In this article, we briefly cover these requirements.
1. Systems and procedure packs which are medical devices themselves
While systems and procedure packs that fall within the scope of Article 22(1) of the MDR are not devices themselves, under the following circumstances systems and procedure packs are considered devices in their own right, and subject to the relevant MDR conformity assessment procedure with the system or procedure pack producer considered a manufacturer with all the obligations incumbent on manufacturers under the regulation:
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- System/procedure pack incorporating products that do not bear the CE marking, which could include a medical device;
- The chosen combination of devices is not compatible in view of their original intended purpose;
- Sterilization has not been carried out in accordance with the manufacturer’s instructions.
2. A MDR statement in relation to systems and procedure packs
Article 22 of the MDR requires system or procedure pack producers to prepare a “Statement” in relation to the systems and procedure packs that they produce (unnecessary for systems and procedure packs that are devices themselves). This statement must include a declaration by the system or procedure pack producer that:
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- They verified the mutual compatibility of the devices and, if applicable, other products, in accordance with the manufacturers’ instructions and have carried out their activities in accordance with those instructions;
- They packaged the system and procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products that have been put together;
- The activity of combining devices and, if applicable, other products as a system/procedure pack was subject to appropriate methods of internal monitoring, verification, and validation.
This statement must be kept at the disposal of the competent authorities, after the system/procedure pack has been put together, for 10 (non-implantable devices)/15 (implantable devices) years, whichever period is longer for the devices that have been combined.
3. Sterilizers
Natural or legal persons who sterilize systems and procedure packs that are not devices themselves (i.e. sterilize the system and procedure pack in accordance with manufacturer instructions) must apply either the MDR conformity assessment procedures under Annex IX or Part A, Annex XI, with Notified Body involvement limited to those aspects of the applied procedure relating to ensuring sterility until the sterile packaging is opened or damaged.
The sterilizer is responsible for drawing up a statement declaring that sterilization has been carried out in accordance with the manufacturer’s instructions.
It is strongly recommended that system and procedure pack producers utilizing third-party sterilizers include provisions on the supply of this statement, and the realization of sterilization activities in alignment with this statement in their inter-company agreements, along with the standard change notification requirements.
4. Labeling requirements for systems and procedure packs
While such systems and procedure packs (when not devices themselves) do not need to bear an additional CE mark, they must bear the following details of the system or procedure pack producer:
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- Name, registered trade name, or registered trademark;
- Contact address, so that their location can be established
Systems and procedure packs must also be accompanied by the information referred to in GSPR 23, with Unique Device Identification (UDI) requirements also being applicable to systems/procedure packs.
5. UDI
UDI requirements applicable to systems and procedure packs under Annex VI are consistent with issuing agency UDI standards and include:
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- Systems and Procedure packs must be assigned and bear their own UDI (UDI-DI + UD-PI) with the natural or legal person that draws up the system and procedure pack statement required under Article 22 is responsible for identifying the system and procedure pack with this UDI;
- As a rule, the system and procedure pack UDI carrier must be affixed to the outside of the packaging and the UDI carrier must be readable, or, in the case of AIDC, scannable, whether placed on the outside of the system/procedure pack packaging or inside transparent packaging;
- Device contents of systems or procedure packs shall bear a UDI carrier on their packaging or on the device itself, except for:
- Individual single-use disposable devices, the uses of which are generally known to the persons by who they are intended to be used, which are contained within a system or procedure pack, and which are not intended for individual use outside the context of the system or procedure pack, in which case they are not required to bear their own UDI carrier;
- Devices that are exempted from bearing a UDI carrier on the relevant level of packaging, in which case they are not required to bear a UDI carrier when included within a system or procedure pack.
As no specific timeframe for entry into force of UDI requirements has been established under Article 123, system and procedure pack producers should consider the timeframes applicable under Article 123(3)(f), based upon the system and procedure pack component device with the highest device class. Additionally, as indicated in MDCG 2018-3 Rev. 1 and MDCG 2018-4, a Basic UDI-DI must be assigned to non-custom system and procedure packs.
6. Importer and authorized representative obligations
While there are no general obligations applicable to both importers and authorized that specifically call out obligations related to systems and procedure packs, where systems and procedure packs are themselves medical devices, those general obligations applicable to importers and authorized representatives for medical devices continue to remain applicable (e.g. verification of CE marking and EU declaration of conformity, etc.) for the system and procedure pack to be placed on the market/made available.
Where systems and procedure packs are not medical devices themselves, the system and procedure pack producer is not a manufacturer under the MDR. In such circumstances, if the system and procedure pack producer is located outside of the EU it does not need to assign an authorized representative (each of the devices in the system and procedure pack manufactured outside the EU would already have their respective authorized representative, however, care does need to be taken by the system and procedure pack producer whether it performs of the activities and has implemented appropriate controls within the scope of Article 16 of the MDR.
MDR devices outside of the EU
In the case of importers of systems and procedure packs assembled outside of the EU which are not devices themselves, as importers are involved in the activity of placing these systems and procedure packs, which contain devices, on the market the following obligations continue to apply to the importer:
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- Verification that the devices provided in the system and procedure pack are CE marked and that the respective EU declarations of conformity have been drawn up, and maintain copies of the declaration of conformity, and any relevant certificates and amendments and supplements for the period referred to in Article 10(8) of the MDR.
- Verification that a manufacturer is identified for each device and (for devices manufactured outside the EU) that an authorized representative has been designated by the manufacturer.
- Verify that the devices in the system and procedure pack are labeled in accordance with the MDR and accompanied by the required instructions for use (where the system and procedure pack producer is introducing its instructions for use in the system and procedure pack, this is particularly a potential area where Article 16 of the MDR may apply).
- Verify, where applicable, that UDIs have been assigned by the device manufacturers.
- Where the importer considers or has reason to believe that any of the devices in the system and procedure pack are not in conformity with the MDR, do not place the system and procedure pack on the market until the devices in question have been brought into conformity and inform the manufacturer and its authorized representative, and inform the competent authority in which it is located.
- Indicate the importer’s name, registered trade name or registered trademark, registered place of business, and address where they can be contacted. Given the nature of systems and procedure packs, this will either be on the system and procedure pack packaging and or in a document accompanying the system and procedure pack.
- Verify registration of the system and procedure pack and add their details to the registration.
- Ensure that, while the device is under their responsibility that storage or transport conditions do not jeopardize compliance with the GSPR and comply with conditions set by the device manufacturer.
- Maintain a register of complaints, non-conforming devices, and recalls/withdrawals and provide the manufacturer(s) and authorized representative(s) of the devices and the distributors of the system and procedure pack, as well as immediately forward information regarding complaints or reports of suspected incidents to the respective manufacturers and authorized representatives.
- Cooperate with manufacturers, authorized representatives, and competent authorities as necessary in accordance with the provisions of Article 13.
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