Medical Device Directive (MDD) 2007/47/EC and 2006/42/EC EHSR checklist

J

Jwreeves

#1
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
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Re: 2007/47/EC and 2006/42/EC EHSR checklist

One last bump in case someone here can help with this. Thanks in advance!
 

somashekar

Staff member
Super Moderator
#4
Re: 2007/47/EC and 2006/42/EC EHSR checklist

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
http://www.slideshare.net/mediqol/changes-to-the-medical-device-legislation-in-europe-presentation
See above link.
It says " Where a medical device also falls within the scope of the directive 2006/42/EC on machinery, for relevant hazards, the device must also comply with the essential health and safety requirements of this directive where these are more specific than in 93/42/EEC
 

Dave-h

Involved In Discussions
#5
Re: 2007/47/EC and 2006/42/EC EHSR checklist

Further to this point.

Us medical device types are familiar with the MDD ER checklist, but I've so-far not found a Machinery Directive ER checklist.

Does anyone know where one may be found?

Thanks,


Dave
 

Peter Selvey

Staff member
Super Moderator
#6
Re: 2007/47/EC and 2006/42/EC EHSR checklist

I'm in the process of preparing an informative website on medical device regulations, which is still very early stage. However, due to recent work, material on Machinery Directive is one subject that is fairly complete and up to date. Please refer to:

http://www.medteq.info/med/node/22

In that page you will find section on the checklist and a link to an excel sheet which can be modified to use as a EHSR checklist. Although care has been taken to prepare the list, users should double check the accuracy before relying on it for legal purposes.

Peter
 

Valli

Involved In Discussions
#7
Re: 2007/47/EC and 2006/42/EC EHSR checklist

Dear Mr.Someshekar,

Can you please help with essential Requirement checklist covering 2007/47/EC & 2006/42/EC & PPE.

Regards,
Valli
 
M

Mo999

#8
Re: 2007/47/EC and 2006/42/EC EHSR checklist

Dear Valli
Did you manage to get a checklist covering 2007/47/EC & 2006/42/EC ?
I need one and saw this old post
Thanks, Mo
 
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