What is a producer under Article 22?

A systems and procedure packs producer is a category of economic operator. These companies, which are not necessarily legal manufacturers, bring together pre-certified medical devices without assuming the full legal responsibility of a manufacturer. As long as a producer is compliant with Article 22, and the combined products retain their original intended use, there is in principle no need for interaction with a Notified Body.

What is a system pack?

A system pack consists of multiple medical devices that are either packaged together or not, are intended to be inter-connected or combined and share the same intended use. These components may come from different legal manufacturers but are combined to function together seamlessly as part of a unified system.

Each individual component has its own CE mark, and the producer is responsible for ensuring that these components work together as intended. For example, a system pack could include surgical instruments, an active device, disposable protective clothing, a flush syringe, for use during surgery. 

There is one major regulatory pitfall for system pack producers: alteration to the intended use of the devices within it. If a functionality or ability is introduced through the combination that is new, the pack is to be treated as a device in its own right, and require a full conformity assessment by a Notified Body. But, if this is not the case and as long as the original intended use remains unchanged, the producer is not responsible for the clinical performance and safety of each individual device.

System pack compliance

To comply with Article 22, system pack producers must:

• Verify that all components carry a valid CE mark
• Include from the legal manufacturers all instructions and warnings in print and/or digital formats
• Verify compatibility of the system components and ensure the intended use of the individual devices is not changed 
• Validate assembly and packaging to demonstrate the integrity of the system pack

What is a procedure pack?

Procedure packs contain multiple medical devices with potential different intended uses. These devices are packed together for a specific medical procedure. 

There’s one major regulatory difference for producers of procedure packs. While system packs require all components to share the same intended use, procedure packs allow for different intended uses as long as they serve the same clinical procedure.

Procedure packs include a combination of devices – such as a butterfly needle, a vacutainer, alcohol pads and a tourniquet as part of a blood sample collection kit  – all intended for use in a single clinical setting or procedure. Another good example is a car emergency kit that includes scissors, bandages, and an arm sling. While these products have different functions and intended uses, they are grouped together for a specific medical purpose.

Procedure pack compliance

To comply with Article 22, procedure pack producers must:

• Ensure all medical devices in the pack have a CE mark
• Include from the legal manufacturers all instructions and warnings in print and/or digital formats
• Verify whether the combination is compatible and justifiable in respect with a specific medical purpose
• Combine and Pack the products according to the legal manufacturers’ specifications and have minimal validation evidence to demonstrate integrity

General compliance obligations under Article 22

Regardless of whether you’re combining and/or assembling system packs or procedure packs, MDR Article 22 sets out a number of shared compliance obligations. Here are 4 key requirements:

1. Statement by the producer– All producers must issue a statement confirming that they have verified the compatibility of devices and acted according to the manufacturers' instructions. They declare packaging the pack with including the relevant user information. They declare that the process of combining and assembly of the pack was subject to methods of internal monitoring, verification, and validation. They will not place an additional CE marking on the article. 
2. EUDAMED registration – Procedure and system packs and their producers must be registered in the EUDAMED – the EUropean DAtabase for Medical Devices – ensuring transparency and traceability. Producers must also obtain a Single Registration Number (SRN) and assign a UDIs (Unique Device Identifications) to their packs.
3. Assessments and Risk management – While producers are not responsible for the clinical safety or performance of individual components, they must conduct assessments related to the combination, packaging, and sterilization of the pack. Altered use, new use or risks introduced by the combination may impact the regulatory status of the product.
4. Sterilization requirements – If a producer sterilizes a pack, they must follow the original manufacturer’s instructions, draw up a statement to such an end and seek conformity assessment of the sterilization procedure by a Notified Body. This does not result in a CE mark for the pack itself.

MDR Article 22 vs MDD Article 12

With the transition from the MDD to the MDR, there have been some notable changes to the compliance rules for system packs and procedure packs:

Traceability

The MDR has reinforced compliance requirements. One of the major changes is the emphasis on traceability, and complaints handling. Packs must now be registered in the EUDAMED, ensuring all individual components within the final product are traceable. This requirement enhances post-market surveillance and ensures greater accountability throughout the supply chain.

Sterilization

While the MDD required verification and validation of packs and their components, the MDR clarifies and strengthens these obligations. Unlike other aspects of MDR compliance, which have transition periods, producers were expected to comply immediately when the MDR came into effect. This means all packs requiring sterilization must be released to the market supported by a notified body approved sterilization process.

Combination of devices

The MDR also provides the option of combining products in a pack, not having a medical device CE. Such products must conform to their relevant legislation and have a justifiable presence in the system or procedure pack. 

Get expert support with pack compliance

Given the complexities of MDR compliance, many manufacturers and pack producers seek expert guidance on operating within the regulations. Here at Peercode Regulatory Consultancy, our experts provide valuable support, helping you:

• Define product specifications in line MDR requirements
• Advise on the viability of product combinations within system and procedure packs
• Ensure correct documentation and registration in EUDAMED
• Navigate Notified Body assessments for sterilization and other key aspects

Navigating ever-evolving regulations can be challenging for businesses in the medical device space. Our team of specialists provides tailored support to ensure your medical device products, system packs, or procedure packs are compliant with the EU’s MDR. 

Contact us today to discuss how we can help your business stay ahead of regulatory changes and avoid compliance risks.