CE Mark Validity despite expired 13485 Certification

K

kanwal

#11
Re: ISO 13485 validity despite expired CE Certification

You can no longer sell the product with the CE mark, until the certification is renewed or reissued.
 
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H

hamendra_2000

#12
Re: ISO 13485 validity despite expired CE Certification

Thanx Mr Kanwal for early reply. my query was that our CE certificate expired in last months, but some Stock still lying in store that have manuf..ed before 4 months ago. and now we are in re-certification process and it will take around 2-3 months. can we sale this stock in EU market or in other than EU market (CE is mandatory only in EU). Waiting for reply. any guideline in MDD 93/42/ECC as amend.
 
K

kanwal

#13
Re: ISO 13485 validity despite expired CE Certification

Technically till your re-certification is completed and new certification is received, the product is not certitifed as on the date of entry into EU.

CE mark is for marketing of the product within EU that has been manufactured as per the approved technical file.

Please note that the product was certified using hte regulatory mechnaism existing on the date of certiification and surveillance audits. Your product would now require to be certified as per the current regulations.

You may wish to read the New Legislative requirements of the EU for greater clarity on the subject.
 
R

Ron Boumans

#14
Re: CE validity despite expired 13485 Certification

Somewhere I think I am missing the point: Your ISO 13485 certification ends in March. What will you be doing after that? Do you plan to renew that certificate? If so, what is the problem? I would expect that this renewal has been taken care off in time and with the new ISO 13485 certificate there should be no problem with the CE certification. If you don't want to renew the ISO 13485 certificate you should cease putting the device on the market.

Or is there some else going on?
 
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