Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

eLabeling Arrives (finally)

Posted by crimsonlanguage on 2013/01/17

For those of us who’ve been in the medical device industry for a few years (or 20), it has sometimes seemed that eLabeling would never arrive. Well, here we are! In March of this year, eLabeling will be available for some professional use devices – the text of the EU Commission Regulation is here:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:01:EN:HTML

Also, the MHRA has a very nice explication of the new Regulation here (and in English, too!):

http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON222581

Everyone should note that a risk assessment is required (of course!) before implementation.

Happy eLabeling!

 

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