current language
Sweden available in the following languages:
or select your TÜV Rheinland country website:

Testing and Assessment Services for In-Vitro Diagnostic Devices


In-Vitro Diagnostics

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.

Unannounced audits

Commission Recommendation of 24th September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU) was published on 24 September 2014 and entered into legal force on 25 September 2013 by publication in the Official Journal of the European Communities.

Read more

New Regulations for Medical Products

pdf New IVDR 1 MB Download
pdf New MDR 1 MB Download
pdf Information according to the new European Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) 290 KB Download

Our portfolio

Bluetooth® Testing
Bluetooth® Testing 

Ensure qualification and listing of your Bluetooth® products.

FCC Compliance Testing and Approvals
FCC Compliance Testing and Approvals 

We are accredited to provide FCC compliance testing and approval for entry into the US market.

Information Technology Products
IT Product Testing 

We test and certify your IT and telecommunication products.

LoRa Alliance Certification
LoRa Alliance Certification Program 

We test and certify your LoRaWAN devices according to the requirements and specifications of the LoRa Alliance.

RED Directive: Telecommunication Products
Telecommunication Products - Compliance with RED Directive  

Conformity Evaluation for Radio Installations and Telecommunications Products.

Testing for Audio and Video Equipment
Testing for Audio and Video Equipment 

Testing and certification for audio and video equipment.

Wi-Fi Testing and Certification
Wi-Fi Testing and Certification 

We provide Wi-Fi testing and certification for wireless products sold around the world.

Wireless Testing
Wireless Testing 

Make Wireless Global Testing and Certification Easy with TÜV Rheinland.

Zigbee Testing and Certification
Zigbee Testing and Certification 

We test and certify products for automated smart systems supported by Zigbee technology.

Contact

Get in contact with us!

Get in contact with us!