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Jwreeves
Looking for a little clarity. When updating ER checklist as per 2007/47/EC, it is required to add the additional 2006/42/EC EHSRs that are not fully meet by 2007/47/EC if your medical device meets the definition of machinery, correct?
However, it is a little confusing when reading timeline. As of March 21, 2010 the machinery Directive ceases to apply and the device is subject to the revised MDD.
Do the EHSRs that are not fully addressed in the revised MDD still need to be met - correct? and still need to be listed in your ER chechlist - correct?
Thanks for clarification
However, it is a little confusing when reading timeline. As of March 21, 2010 the machinery Directive ceases to apply and the device is subject to the revised MDD.
Do the EHSRs that are not fully addressed in the revised MDD still need to be met - correct? and still need to be listed in your ER chechlist - correct?
Thanks for clarification