17.10.2018
 

Notification of production-free times for manufacturer under MDD

 

Dear Sir or Dear Madam,

we would like to inform all manufacturers according to medical device directive MDD to report the Notified Body in writing about production-free periods (e.g. due to vacation) in the up-coming year. Information is required not later than second calendar week of each year. TÜV NORD CERT must also be informed without delay of any changes in production-free periods during the year. This also applies to the manufacturers’ critical suppliers.
(Source: 2013/473/EU.)
In the case of OEM/PLM constellations, an unannounced audit may be waived if proof has been submitted in advance that the OEM has already been subjected to an unannounced audit by another Notified Body.

Here you will find the form for reporting non-production times.

Please send your notifications to medical@tuev-nord.de

 

 

 
 
 
 

TÜV NORD CERT GmbH

Langemarckstr. 20
45141 Essen

Tel.: 0800 2457-457
(kostenlose Service-Hotline)

info.tncert@tuev-nord.de
www.tuev-nord-cert.de

 

Dieses Mailing wird im Auftrag der TÜV NORD CERT GmbH mit Sitz in Essen betrieben.

Amtsgericht Essen, HRB 9976 
USt-Id-Nr.: DE 811389923
Steuer-Nr.: 111/5706/2193

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