Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm

Get In Touch:

Get In Touch:

Notified bodies

EU Notified Body

A notified body is an independent organisation designated by an EU country to assess the conformity of products before being placed on the market. Under EU MDR 2017/745, the notified body is also called a conformity assessment body.   A conformity assessment body (CAB) or a notified body is responsible for carrying out the conformity assessment procedure mentioned in the applicable Regulation. What does a notified body do? A notified body assesses whether the product conforms to the require...
Read More

EU IVDR’s First certification for the type of IVD and Notified Bodies Procedures

A short article based on MDCG 2021-22 guidelines on “first certification for the type of devices and the corresponding procedures to be followed by the Notified Bodies, ” established based on Article 106 of Regulation 2017/745  for Class D IVDR devices. Additionally, this guide talks about the conditions to be followed by the Notified bodies, whether to consult the expert panel for the performance evaluation report of the IVDR devices. According to Article 48(6) of IVDR 2017/746, th...
Read More