Standards in general
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.
a) Proving compliance
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"
- Legal requirements: MDD essential requirements for software lifecycle processes
- Harmonized standard: IEC 62304
- QMS and documented procedures: The SOP software development respectively the software development plan require a code-review
- Documents and records: documented code-review in day X by person Y with result Z
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.
b) Examples for harmonized standards
The term harmonized standards include
- IEC 62304: Software lifecycle processes for medical devices
- IEC 62366: Application of usability engineering for medical devices
- ISO 14971: Application of risk management for medical devices
- IEC 60601-1: Programmable, electrical, medical systems: basic safety and essential performance
- ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes
c) Problems with harmonized standards
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.
More information about specific 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!