R
Russbigbelly
Hello,
New to the forum... I am currently tidying up a technical file for a type 1 medical device (non measuring) so no notifying body to audit. I am unsure on a small point of my declaration of conformity. My issue is on the declaration I have the usual layout but I am unsure what MDD to refer to. On most of our older tech files (pre March 2010) it is 93/42/ECC but there is the 2007/47/EC which has amended 93/42/ECC.
What directive should I put on the declaration? In my draft I have " Compliance with directives 93/42/ECC as amended by 2007/47/EC" in guidelines it says that it is automatically deemed to refer to the revised version so it would be just 93/42/ECC?
A long post for a basic question ! Any help would be appreciated.
Thanks
Rus
New to the forum... I am currently tidying up a technical file for a type 1 medical device (non measuring) so no notifying body to audit. I am unsure on a small point of my declaration of conformity. My issue is on the declaration I have the usual layout but I am unsure what MDD to refer to. On most of our older tech files (pre March 2010) it is 93/42/ECC but there is the 2007/47/EC which has amended 93/42/ECC.
What directive should I put on the declaration? In my draft I have " Compliance with directives 93/42/ECC as amended by 2007/47/EC" in guidelines it says that it is automatically deemed to refer to the revised version so it would be just 93/42/ECC?
A long post for a basic question ! Any help would be appreciated.
Thanks
Rus