What name should appear on an IEC 60601 conformity certificate for hardware supplied by a third party?

Question

Our medical device consists of both hardware and software. The hardware is supplied by a third-party supplier, who is also organizing the conformity testing to IEC 60601. The resulting conformity certificate will be part of our Technical Documentation for the notified body.

My question: Which name should be listed on the IEC 60601 conformity certificate — our company (as the Legal Manufacturer), or the hardware supplier (as the critical supplier)?

If anyone has experience or practical advice on this, I would appreciate it.

Dr. Oliver Eidel · Accepted Answer

According to IEC 60601-1, the name on the certificate should match the entity identified as the manufacturer on the equipment. If your supplier designs and manufactures the hardware according to their own specifications and sells it on the open market, then their name should be on the certificate. However, if the supplier manufactures the hardware for you, according to your requirements, and you are identified as the legal manufacturer, then your company should be listed on the certificate. The key is who takes responsibility for the design and manufacture of the equipment per IEC 60601-1 clause 7.2.2.

Answer

Based on my experience, if your supplier organizes the testing for their hardware component, the certificate usually lists their name or reference. In your Technical Documentation, you would state that this specific component (with its certificate) is part of your device, ensuring full traceability from the supplier's certificate to your finished product.

Answer

Before physically testing to IEC 60601, the test house must review the risk management file. The risk management file is related to the entire system, including both software and hardware, and is the responsibility of the manufacturer, not the supplier.

Answer

Thank you all for your input. After some research and asking around, we decided to put our company name on the certificate since we are the Legal Manufacturer as indicated on the label and documents.

What name should appear on an IEC 60601 conformity certificate for hardware supplied by a third party?

4 Answers

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