Common Sense Systems

CE Marking

How do you know?

Posted on February 8, 2015 | 0 Comments

John at 55!

John at 55!

“How do you know?”

It’s a question I frequently ask myself – and it’s a question that often comes to mind when I’m listening to other people.

For example, one of my clients once claimed that the device his company manufactured did not need to carry the CE Marking. Knowing the nature of the device and the nature of many of the Directives that drive the requirements for CE Marking, this seemed hard to believe.

So I gently asked “How do you know?”

His reply was that one of the other members of his firm had found an exemption. To their understanding, because their device was intended for use in research laboratories, they thought that a particular exemption for medical devices would also be applicable to their device.

Of course, this is not true. An exemption granted by one Directive, such as the Medical Device Directive, does not create a blanket exemption from all other Directives, such as the Low-Voltage Directive, or the EMC Directive.

This problem – of knowing how we know something – is the subject of epistemology. Epistemology is the investigation, or study, of what distinguishes justified belief from opinion.

I have found epistemology to be a fascinating subject. And when I think of how many decisions I make on a day to day basis, and how many of those decisions might be on the basis of unsubstantiated or unchecked assumptions, it’s a bit concerning!

My personal strategy, and the strategy we use at Common Sense when working with our customers, is to always work from a basis of reason and evidence. Over the years, I have found that this is the only practical means for ensuring that we are delivering real value to all of our stakeholders. And in fact, in my view, it’s the only way one can really live.

In closing, I want to thank you for reading this post. I hope you’ll consider sharing your thoughts with me.