Product certification IVD MD
We are Authorized Body No. SKTC-113 and Notified Body No. 2265 for:
- Directive of the European Parliament and of the Council 98/79/EC on in vitro diagnostic medical devices as amended.
For a better overview of how the product certification takes place, you can consult the following chart: Flowchart of Conformity Assessment of IVD MD in NB2265.
In case of interest in our services in the field of Product Certification, please, send filled document "Questions for Quoting" on our e-mail address info@3ec.sk
If you are interested in our services, please, contact our office.