Identification of standards in GSPRs

[CBGus]

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]

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.