Standards are documents, written by national or international standardization committees such as ISO and IEC, to document the "state of the art". They usually do not describe best practices or even "state of research". Rather consider the standards as minimum requirements that you as a professional company should not fall short of.
Some standards, the so-called harmonized standards, the EU has identified and published in its Official Journal. If manufacturers comply with these harmonized standards, you can go (eg auditors) on the assumption that essential requirements laid out in Annex I of the MDD respectively MDR are met.
An example of a "chain of evidence"
The harmonized standards are not legally binding, neither in EU or in FDA. However, without standards it will be hard for medical products manufacturer to provide evidence that their products have met the requirements.
The term harmonized standards include
As the European Community stopped the process of harmonizing standards, the standards, that are currently listed on the EU website, do no longer reflect the state-of-the-art. An example is the IEC 60601-2-12. This standard already was replaced by IEC 80601-2-12 (not harmonized). And if you read in Beuth.de, you will also see that the IEC 60601-2-12 is quoted as invalid.
More and more notified bodies insist, that manufacturers follow the latest versions of the respective standards.
If you are interested in information about a particular standard, then please read on here:
Are you not so sure whether your medical product meets the essential requirements? or whether you have carefully thought of the harmonized standards? Professor Johner and his team would like to help you, contact us now!