Exercising the route to compliance by use of harmonized standards as “Presumption of Conformity”.
For many, this is the default choice possibly because it is easier.
However, proceed with caution.
- If you are relying on third-party test labs to accurately identify the harmonized standards for you, there is a risk with this approach. It is known that there are inconsistencies between third-party test labs when identifying applicable standards. After all, as a manufacturer, it is your ultimate responsibility to decide what applies or doesn’t apply because you understand the design and use of your products more than anyone.
- In theory, the standards that you have identified as applicable will be included in your design requirements and risk assessment. You could potentially design products and mitigate risks to the wrong standards.
- Do the standards cover all the regulatory requirements based on novelties and technologies on your products? You may need to go beyond the standards to substantiate your evidence.
- If your products or components were certified/approved with “conditions of acceptability”, How will this impact the regulatory requirements that you are claiming “Presumption of Conformity” by the use of harmonized standards?
I would recommend that as part of your design process is to include a verification of proposed harmonized standards to be applied and to identify if additional evidence is required beyond the harmonized standards scope to meet the regulatory requirements.
By doing so, you are demonstrating that you are designing and mitigating risks to an accurate set of specifications.
Author: Michael Wetherington