EN ISO 13485:2003 harmonized to AIMD, MDD and IVDD

[wrodnigg]

EN ISO 13485:2003 "Medical devices - Quality management systems - Requirements regulatory purposes"
has been harmonized by 2004-04-02.

From now on Medical Devices - Quality Management Systems can be "officially" certified according to this standard.
EN ISO 13485/8:2000 remain harmonized until 2006-07-31 (end of agreed transition period).

 

[Marc]

Thanks for the update! We appreciate it!

 

[celeo]

chart of when 13485/46001 certs expire

The attached page may give some useful guidance for companies already holding certificates to the old 13485: 1996 or EN 46001. Be careful to plan your transition audit/certification to EN ISO 13485: 2003 to avoid the log jam when the old versions finally expire.