Product certification

We are Authorized Body No. SKTC-113 and Notified Body No. 2265 for:

  • Council Directive 93/42/EEC concerning medical devices as amended,
  • 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  MD IVD MD in  NB2265.

In case of interest in our services in the field of Product Certification, please, send filled document "Questions for Quoting" via contact form.

If you are interested in our services, please, contact our office.

Confirmation that we are authorised to perform the Conformity Assessment of Medical Devices in accordance with the mentioned directives and the scope of activities can be found on official NANDO website.

One of the most important aspect of our work is impartial and objective assessment of evidence. Therefore we decided to establish and keep Impartiality Policy in Product Certification which represents our commitment and intention.

Download files
Questions for Quoting
DOC 178,50 kB
Minimum requirements for Technical Files
PDF 32,86 kB
General terms and conditions for MD & IVD MD
PDF 296,27 kB
Rules and conditions for affixing CE Mark
PDF 60,88 kB
Blue Guide
PDF 3,55 MB
EU Commission Recommendation 2013/473/EU on Unannounced Audits
PDF 215,45 kB
FAQ - Implementation of EN 60601-1
PDF 484,39 kB
Medical Devices – Compliance with RoHS
PDF 167,32 kB
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