Systems and Procedure Packs

What Are the Regulatory Requirements?

Article 22 of the EU MDR establishes the regulatory framework for systems and procedure packs. The applicable requirements depend on the products included, their intended purposes, their compatibility, and whether sterilisation is performed before the combination is placed on the market.

• Verification of Compatibility: The person responsible for combining products must verify that the devices and other eligible products are mutually compatible in accordance with their manufacturers' instructions and within the specified limits of use. The combination must be suitable for the intended medical purpose, and the assembly process must be subject to appropriate internal monitoring, verification, and validation.
• Preparation of the Article 22 Statement: Where the conditions of Article 22(1) apply, the system or procedure pack producer must prepare a statement in accordance with Article 22(2). The statement confirms that:
• The compatibility of the included devices and products has been verified.
• The combination, packaging, and accompanying information comply with the applicable requirements.
• Appropriate methods of internal monitoring, verification, and validation have been applied.
• Sterilisation Requirements: Where the system or procedure pack is sterilised before being placed on the market, the responsible person must comply with Article 22(3). The conformity assessment procedure is limited to the aspects relating to achieving and maintaining sterility until the sterile packaging is opened or damaged. The responsible person must also prepare a statement confirming that sterilisation was performed in accordance with the manufacturers' instructions.
• When Is the Combination Treated as a Medical Device in Its Own Right?: Under Article 22(4), a system or procedure pack must be treated as a medical device in its own right when:
• It incorporates devices that do not bear the required CE marking.
• The selected combination is incompatible with the original intended purposes of the included devices.
• Sterilisation has not been carried out in accordance with the manufacturers' instructions.

Labelling and UDI Requirements

Systems and procedure packs covered by Article 22 must comply with the identification and information requirements.

Under Article 22(5), a system or procedure pack that qualifies under Article 22(1) or 22(3) does not receive an additional CE marking solely because it is a system or procedure pack. Its labelling must identify the responsible person by name or registered trade name or trademark and provide an address at which that person can be contacted. The pack must also be accompanied by the information required under Section 23 of Annex I.

The applicable UDI requirements include:

• Assignment of a UDI to the system or procedure pack, including a UDI-DI and UDI-PI.
• Assignment of a Basic UDI-DI and provision of the required information to the UDI database, in accordance with the applicable requirements.
• Placement of the UDI carrier on the system or procedure pack in accordance with Annex VI, Part C.
• Identification of the individual devices within the combination, subject to the applicable UDI requirements and exemptions.

Where a combination is treated as a medical device in its own right under Article 22(4), the responsible person must fulfil the applicable manufacturer obligations, including the relevant conformity assessment, CE marking, and UDI requirements.

MEDREG assist medical device manufacturers and pack assemblers in establishing regulatory compliance for systems and procedure packs under Article 22 of EU MDR 2017/745.