Maybe you purchased the ISO 14971 to be compliant in the U.S. medical device market, but now you want to go to the European market. Do you really need to now move the EN ISO 14971, or can you just use the ISO 14971?
Well, the answer is: you will need the EN ISO 14971.
The International Standards Organisation (ISO) and the International Electrotechnical Commission (IEC) publish standards that can apply internationally. Once these are published, one of the European Standards Organisations takes a look at this standard and then publishes a wrapper around this standard (such as a series of annexes) which include information specific to the European market. Some of the most important information for the European market, such as how to demonstrate conformity to the Medical Device Regulations or Medical Device Directives can be found there.
Once the European Standards Organisation has finished publishing their version of the standard, the National Standardization Bodies then are obliged to adopt these standards and then make them available to customers. This means, when you purchase your EN standard, you will be purchasing from them.
If you already have the ISO standard, sometimes it may not be necessary to purchase the EN ISO standard. If you can get your hands on a copy of the EN ISO from a friend, you might be able to see if there are significant additional requirements or not.
Useful links:
Database of consensus standards for the U.S. market: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/results.cfm
Harmonized standards (under the Medical Device Directives – the Medical Device Regulations were not yet published at the time of this blog post) for the European market:
List of National Standardization Bodies:
