IEC/EN 60601-1 Certificate required before CE Marking?

[LievenDW]

I am not an IEC/EN 60601 expert. I do know medical devices must comply with EN 60601-1 (and other harmonized standards) and that a conformity assessment is required before affixing the CE mark. But can a manufacturer rely on their own test results and documentation to claim compliance with EN 60601-1, or do they need a certificate or report from a certification body before affixing the CE mark?

 

[Marcelo]

Re: 60601-1 certificate required before CE marking?

I am not an IEC/EN 60601 expert. I do know medical devices must comply with EN 60601-1 (and other harmonized standards)

NO they don't, compliance to standards is voluntary (although it's the easiest way to show compliance with related essential requirements - these are mandatory)

But can a manufacturer rely on their own test results and documentation to claim compliance with EN 60601-1, or do they need a certificate or report from a certification body before affixing the CE mark?

You can use your own results and documentation, although a third party test house or certification may be viewed by some as more "reliable".

 

[yodon]

Re: 60601-1 certificate required before CE marking?

You can use your own results and documentation, although a third party test house or certification may be viewed by some as more "reliable".

Just to add on a bit... that 3rd party test house needs to be an accredited lab or else the reviewer may not accept the conclusions. If you do submit your own data, expect a more lengthy review process. That's been what I've seen.

 

[Peter Selvey]

For all standards (not just IEC 60601-1) the following minimum requirements can be derived from the law (MDD):

- a report showing compliance with the standard, or pointing to alternate solutions for each and every requirement in a harmonized standard not applied;
- the report should be prepared by person(s) that are appropriately qualified and experience in the scope of tests
- the reports should show results of tests, calculations etc (in sufficient detail to to be audited by the notified body)
- there should be records of traceability for any equipment used to make measurements

It is not necessary for a third party lab or certified report, and it is very common not to use a lab, especially for the less popular standards.

For popular standards like IEC 60601-1 it is usually efficient to use a third party lab as they have the experience, equipment and are set up for the reporting. However, IEC 60601-1 these days is very broad and includes subjective areas. It can be more efficient to limit the test lab to objective, well established tests and exclude parts of the standard which are highly subjective (e.g. PEMS). The excluded parts then need to be covered by report(s) prepared by the manufacturer, and for completeness there should be a cover report which ties the sub-reports together and provides an overall statement of compliance with the standard.