TÜV SÜD launches IECEE Component Certification Programme for medical technology components

Greater efficiency and safety in the approval process
The IECEE CCP certificate is intended for legal manufacturers of medical devices, as well as for manufacturers of components and assemblies. The latter are usually certified according to ISO 13485 rather than the MDR/IVDR. Testing electrical safety at the component level early on can significantly reduce sources of error and safety risks in later product testing.

Components that are already certified according to IEC 60601-1 can be integrated directly into the end product, ensuring compliance and eliminating the need for further testing. For medical device manufacturers, this means reduced risk when testing the end product, faster approval procedures, lower costs, and less technical rework. Suppliers, in turn, benefit from a clear competitive advantage, as they can demonstrate internationally recognised, tested quality – a decisive argument in a globally regulated market.

International recognition through the IECEE system
Tests carried out as part of the IECEE CCP adhere to IEC 60601-1:2020 and its associated standards. These tests are recognised internationally through the IECEE (IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components) CB Scheme. The CB Scheme is a global system for the mutual recognition of testing and certification based on harmonised IEC standards.

It enables manufacturers to facilitate market access in numerous markets with a single test, making a significant contribution to the global safety, quality and comparability of electrotechnical products. Additionally, TÜV SÜD offers supplementary certifications, including Nationally Recognised Testing Laboratory (NRTL) certification for the USA and Canada, INMETRO certification for Brazil, and voluntary TÜV SÜD Mark certification for medical devices. This comprehensive portfolio provides manufacturers with a one-stop testing and approval pathway, covering everything from component testing and end product certification to international market approval.

Advantages of the IECEE CCP
The IECEE Component Certification Programme offers several practical advantages. It allows components to be tested and certified early on in accordance with IEC 60601-1, thereby helping to optimise and accelerate end-product certification. It also reduces technical risks and the need for retesting, increases transparency in the development process, and lowers approval costs. As the tests are internationally recognised, both manufacturers and suppliers alike benefit from clear traceability of safety requirements and a significant competitive advantage in the market.

The IECEE CCP offers clear added value to manufacturers and suppliers of medical technology in the form of tested safety at component level, faster approval processes, and greater reliability throughout the entire product life cycle.

Further information is available at:
• TÜV SÜD IECEE Component Certification Programme (CCP)

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