MDR vs. Machinery Directive - Single EU Declaration of Conformity

RA_QA_Expert

Involved In Discussions
Hello colleagues,

According to MDR Article 1 (12), medical devices that are also machinery shall also meet the Essential Health & Safety Requirements (EHSR) of the Machinery Directive (2006/42/EC; MD) to the extent to which those EHSRs are more specific than the General Safety & Performance Requirements (GSPR) set out in Annex I of the Medical Device Regulation (EU 2017/745). That means only EHSRs must be evaluated, but not Machinery specific conformity assessment route must be taken.

If device complies with both MDR and MD, can/should/must Machinery Directive be mentioned also on a EU Declaration of Conformity?

EC Blue Guide states that the single declaration of conformity can be made up of a dossier containing all relevant individual declarations of conformity, but our notified body, says that machinery directive cannot be on the declaration, because we claim compliance with EHSR only. For business reason we would prefer to have both MDR and MD mentioned.

What do you think? Thank you
 

Al_Z1

Involved In Discussions
We simply added additional document to our technical file with full assesment of EHSR (Annex I) of MD with comparison to Annex I of MDD (it was for MDD at that time) and appicability to our device. It was OK for our NB.
 

RA_QA_Expert

Involved In Discussions
Thank you for your input, understood. But if you use this approach, can Machinery Directive be mentioned in a EU Declaration of Conformity and claim compliance with this directive?
 
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