Identification of standards in GSPRs


Good morning,
I have been asked this question a number of times and when discussing with other regulatory affairs colleagues have had a number of responses.
We are based in the UK but sell in many countries so my question(s) are:
Do we reference the IEC/ISO standard and date regardless of where we sell
Do we reference the BS EN version and identify differences from the IEC/ISO standard
Do we have to reference the standards adopted by the country in which we sell?
Sorry if this seems long winded but I would appreciate any help.
Best regards

Billy Milly

Quite Involved in Discussions
To indicate conformtiy with your (UK) legislation, you need to state BS standards (MHRA is intetested in BS) and to indicate confomity with EU/MDR, you need to state the EN (harmonized) standards.
We tipically state EN and national standard, e.g. EN ISO 13485:2016 (BS EN ISO 13485:2016) to avoid confusion and cover both. I cannot advise on differences as our "national" stadnards are tipically same as ENs with the translated name and no differences in content.
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