New Common Technical Specifications
03/16/2009
New Common Technical Specifications (CTS) Annex II List A IVD devices have been published in the Official Journal of the European Union.The use of CTS is required by Article 5.3 of the IVD Directive (98/79/EC). IVD companies making these devices must review "new or revised regulatory requirement' as per clause 5.6.2 (h) of ISO13485.
| Attachment | Size |
|---|---|
| Read the Essential Points of the New CTS | 85.95 KB |
