harmonised standards and consensus standards
Developing a medical device will bring you and your team to the terms of harmonised and consensus standards. Read here what these terms mean and why you should consider them during your product development.
What is a standard
A standard is neither a law, nor a regulation or mandatory requirement. Instead, it is an industry agreement on specific processes, definitions or tests. As standards are agreed among industry representatives of a country, a region or internationally, these standards can come from different interest groups. The most prominent two groups are the International Standard Organisation (ISO) and the American Society for Testing and Materials (ASTM). These and the other organisations develop standards according to industry needs and explore new areas, such as IoT, cybersecurity, blockchain, nano-scale materials, radiation as in 5G, among others.
So, standards define the industry common understanding to establish a level of quality and safety.
As Europe uses EN mainly for ISO and IEC standards, the US does not use a prefix to show harmonisation. Instead of harmonising standards with the US standards, the US FDA gives a consent to the ISO and IEC standards, among others. Such recognized consensus standards can be retrieved as list from the FDA. Please be adviced that recognized consensus standards are not always the same edition as the latest edition of the standard as well as not the latest edition of a harmonised standard.
Why to consider standards during development
Within regulated industries, such as the medical device business, regulations often refer to harmonised standards to be considered during development. Considering harmonised standards implies inherent compliance to the regulation, especially in those cases in which the regulation names specific standards. In the MDR 2017/745, the following standard is specifically named.
- ISO 14155