Systems and Procedure Packs of Medical Devices in Norway

1. Overview

Medical devices are often combined for use in a specific medical procedure with a specific medical purpose. The combined configuration is described in MDR as systems and procedure packs, cf. MDR Article 22. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/systems-and-procedure-packs-of-medical-devices

2. Definitions

• Procedure pack: A combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose, cf. MDR Article 2 (10).
• System: A combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose, cf. MDR Article 2 (11). Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/systems-and-procedure-packs-of-medical-devices

3. Contents of Systems and Procedure Packs

Systems and procedure packs can contain:

• Medical devices bearing the CE marking (IVD and MU).
• Other products that meet the requirements of the regulations that apply to these products. Examples include first aid kits, orthodontic procedure kits, catheterisation kits, wound change kits, and X-ray systems. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/systems-and-procedure-packs-of-medical-devices

4. Declaration by the Person Placing on the Market

A statement shall be prepared by the person who places the device on the market as a system or procedure pack. The declaration must confirm compatibility checks, packaging and information provision, internal monitoring/verification/validation, and sterilisation compliance where applicable. The declaration must be kept available to competent authorities for at least 10 years (15 years for implantable devices). Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/systems-and-procedure-packs-of-medical-devices

5. When the Assembler Assumes Manufacturer Obligations

The assembler assumes manufacturer obligations if the system/procedure pack contains non-CE-marked devices, incompatible combinations, or non-compliant sterilisation. In such cases, full conformity assessment under MDR Article 52 applies. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/systems-and-procedure-packs-of-medical-devices

6. Labeling and Information Requirements

Devices shall not bear additional CE marking. Labels must include the name and address of the assembler, information per MDR Annex I (23)/IVDR Annex I (20), UDI-DI/UDI-PI, expiry date based on shortest shelf life, lot number, sterility maintenance info, and a list of components. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/systems-and-procedure-packs-of-medical-devices

7. Registration and Traceability

The assembler must obtain an SRN, assign a Basic UDI-DI, and register in EUDAMED (per MDR Article 29 (2)). See MDCG 2018-3 guidance for details. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/systems-and-procedure-packs-of-medical-devices

8. Procedure for Unacceptable Risks

If unacceptable risk to health and safety exists, appropriate corrective action must be taken throughout the EU/EEA (MDR Article 95 (3)). Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/systems-and-procedure-packs-of-medical-devices

9. Contact Information

For further guidance, contact NoMA Units for medical devices at +47 22 89 77 00 or meddev-no@noma.no. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/systems-and-procedure-packs-of-medical-devices