current language
Serbia available in the following languages:
or select your TÜV Rheinland region / country website:

Services for In-Vitro Diagnostic Devices


TÜV Rheinland

For the detection of disease, infection or other health conditions, in-vitro diagnostics are used both in professional medical settings and by consumers at home. The reliability and safety of these products is your company’s top priority as you strive to compete in the health care market. With our services and top-notch staff of specialists, you can meet compliance demands while boosting consumer confidence in your brand. Partnering with our experts gives you access to our state-of-the-art laboratories, know-how and unparalleled experience.

Application for designation under the Regulation for In vitro Diagnostica (IVDR) 2017/746

TUV Rheinland DNA sequence

Notified Bodies are allowed to apply first-time since November 26, 2017 for designation under the Regulation for In vitro Diagnostica (IVDR) 2017/746. We are glad to inform you, that our application is already filed and covers a comparable scope as currently maintained by us.

New Regulations for Medical Products

pdf New IVDR 1 MB Download
pdf MDR / IVDR declaration of interest 46 KB Download
pdf Regulation (EU) 2017/745 1 MB Download
pdf Regulation (EU) 2020/561 522 KB Download
pdf Medical Device Regulation FAQ 320 KB Download

Our portfolio

Contact

Get in contact with us!

Get in contact with us!