PT TÜV NORD Indonesia Newsletter

Notification of production-free times for manufacturer under MDD

 

Dear Sir or Madam,

We would like to inform all manufacturers according to Medical Device Directive MDD to report the Notified Body TÜV NORD CERT in writing about production-free periods (e.g. due to vacation) in the up-coming year. Information is required not later than fifth 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

Many thanks.

Yours sincerely
Your Team
Medical Device International

 
 
 
PT TÜV NORD Indonesia
(021)7883 7336
indonesia@tuv-nord.com

This newsletter is carried out on behalf of TÜV NORD Indonesia
based in Jakarta, Indonesia.
Perkantoran Hijau Arkadia,
JL. TB Simatupang Kav. 88
Jakarta Selatan