System and procedure packs streamline medical procedures by combining compatible components into a single unit. procedure packs may contain non-device components like medications or disinfectants, and system packs are made up entirely of medical devices that are intended to work together.
Both must ensure that all contained devices are CE-marked, compatible, and safe for use in accordance with Article 22 of MDR (EU) 2017/745. Assemblers are required to confirm that the general safety and performance requirements (GSPR) and ISO 15223-1 labeling are being followed.
System: A combination of products, packaged together or not, designed to be interconnected or used in combination to achieve a specific medical purpose.
Procedure Pack: A combination of products packaged together for a specific medical purpose, but not necessarily used interoperable.
Key Differences
- Both must serve a medical purpose, distinct from the intended purpose of individual products.
- Procedure Packs: Products are packaged together but don’t need to work in combination.
- Systems: Products may or may not be packaged together but must work in combination.
- Combination products (devices with medicinal or biological components) are excluded from these definitions.
- Convenience Kits: Customized packs based on customer requirements, which typically have no regulatory responsibility.
Example: Procedure Pack
Who Can Sell Systems or Procedure Packs?
Manufacturers: Manufacturers create, produce, and sell medical devices, ensuring they meet safety and performance standards as per regulations.
System Integrators/Procedure Packers (SPP): SPPs combine products from various manufacturers into kits or systems for sale. They can also act as importers or distributors. SPPs Manufacturers must register in EUDAMED and obtain a Single Registration Number (SRN).
Manufacturers with Dual Roles: When manufacturers combine their own products into systems, they act as both Manufacturer and SPP. In this case, they must follow SPP guidelines.
General Rules for SPP
Combining CE-Marked Devices: SPPs are authorized to combine CE-marked devices to create functional systems. This ensures that all components within the system meet the essential safety and performance requirements outlined by the applicable regulations.
Incorporating CE-Marked IVD Devices: In addition to standard CE-marked devices, SPPs can include in vitro diagnostic (IVD) devices in their systems, provided these devices comply with the In-Vitro Diagnostic Regulation (IVDR). This allows for the integration of diagnostic tools alongside other medical devices.
Using Devices Conforming to Other Regulations: SPPs may also include devices that conform to other regulatory standards, such as the Ionizing Radiation Regulations (IRR) or specific European Economic Community (EEC) directives. These devices must align with the applicable requirements to ensure the overall safety and effectiveness of the combined system.
Labelling Procedure for Systems and Procedure Packs: Proper labelling of SPPs serves to communicate critical details about the product, its components, and compliance with regulatory requirements. Each system or procedure pack must include the following information on its label:
- Producer Information: The name and registered trademark of the pack producer to ensure clear identification.
- Responsible Entity: Contact details, including the address of the organization accountable for the pack.
- Expiration Date: Determined by the shortest shelf life of any included component to ensure safety and efficacy.
- Lot Number: A unique identifier for traceability, allowing quick identification in case of recalls or incidents.
- Component List: A detailed inventory of all items within the pack for transparency and usability.
- Sterility Information: Clear indications if the pack is sterile, including instructions for maintaining sterility until use. when a sterilized product is included in the pack, the CE mark must be placed next to the manufacturer’s name and address to indicate compliance with sterilization standards.
- Medical Device (MD) Symbol: The use of the MD symbol is optional for procedure packs. If CE-marked devices are included, the MD symbol should accompany the manufacturer’s information to indicate medical device compliance.
Unique Device Identification (UDI) for Systems and Procedure Packs
UDI is a system designed to enhance the traceability of medical devices throughout their lifecycle. It provides a standardized identification system that benefits manufacturers, regulators, and healthcare providers.
UDI Placement
The UDI carrier (e.g., barcode or RFID) should be placed where it is easily visible and accessible. The placement depends on the pack’s design and components. Exemptions apply for certain medical devices, such as reusable single-use devices (SUDs) with clear intended use.
Data Elements
The UDI consists of two parts:
Device Identifier (DI): A fixed code specific to the product.
Production Identifier (PI): Variable data, such as lot number, serial number, or expiration date.
No Fixed Timeline
The timeline for UDI application depends on the type and classification of the device. Compliance requirements are phased based on risk class.
UDI Benefits
Facilitates faster recalls or corrections. Enhances post-market surveillance and vigilance. Improves inventory management and reduces errors in healthcare delivery.
Technical Documentation for Systems and Procedure Packs
Content Details
- Component List: A detailed inventory of all items within the pack, including their descriptions and intended purposes.
- Instructions for Use: Clear and concise directions for using the pack and its components safely.
- Packaging and Labelling Information: Specifications on how the pack is packaged and labelled, ensuring proper handling and identification
Safety and Compatibility
- Risk Assessment: A thorough analysis of potential risks associated with the pack and its components, along with measures to mitigate them.
- Compatibility Verification: Evidence that the products within the pack work together safely and effectively.
Performance and Sterilization
- Performance Testing: Results demonstrating that the pack meets all performance requirements.
- Sterilization Process: Details of sterilization procedures, including certificates from notified bodies confirming compliance.
Declaration of Compliance: A formal statement verifying that the pack conforms to all applicable MDR requirements.
Additional Facts About Systems and Procedure Packs
- CE Marking: If all devices within the pack are already CE-marked, no additional CE mark is required for the pack itself.
- Risk Class: The pack is classified according to the highest risk class of the devices included.
Vigilance Reporting and Incident Management
- Component-Specific Issues: The manufacturer of the individual component is accountable.
- Combination Issues: The System Integrator or Procedure Packer (SPPP) takes responsibility for problems arising from the combination of components.
Best Practices
- Mandates and Agreements: Establish clear written mandates between manufacturers and SPPs outlining roles and responsibilities for incident handling.
- Open Communication: Ensure effective collaboration to address and resolve issues promptly.
- Flexible MDR Provisions: Use the MDR’s flexibility to define specific vigilance management responsibilities.Top of Form
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Conclusion
By maintaining detailed technical documentation and adhering to vigilance protocols, SPPs can ensure compliance, enhance product safety, and promote trust among stakeholders in the medical device supply chain Understanding these distinctions and responsibilities ensures smoother regulatory processes, compliance, and safe delivery of medical devices to the market.
Reference: 1) MDR – Article 22 – Systems and procedure packs.
2) MDCG 2018-3 Rev.1 Guidance on UDI for systems and procedure packs.
3) MDCG 2018-4 Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs.
Author:
Anjali Kantesariya (Biomedical engineer)
Jr. regulatory consultant-Medical Device.