Conformity Assessment according to the IVDR
We are Authorized Body No. SKTC-113 and Notified Body No. 2265 for:
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices as amended.
For a better overview of how the conformity assessment process of in vitro diagnostic medical devices takes place, you can consult the following chart: Flowchart of MD Conformity Assessment in NB2265.
In case of interest in our services in the field of Conformity Assessment of medical devices, please, send filled document "Questions for Quoting", "List of products" and other requested document on e-mail address stated in the form. Forms are evaluated in the Certification Board once a month. We will inform you about the result of the evaluation.
If you are interested in our services, please, contact our office.