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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.

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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

Active und Non-Active Medical Devices
Active and Non-Active Medical Devices 

Active and Non-Active Medical Devices.

Approvals for Greater China
Approvals for Greater China 

Let us help you with product approvals for China, Taiwan, and Hong Kong.

Bluetooth® Testing
Bluetooth® Testing 

Ensure qualification and listing of your Bluetooth® products.

CB Procedure
CB Scheme 

Safety testing and CB certification for electrical and electronic components and products.

EEBus
EEBus 

The new data communication standard connects the smart home and the smart grid.

EN ISO 13485 Certification
Certification According to EN ISO 13485 

Validating Your Quality Management System.

Energy Efficiency and Saving Energy
Energy Efficiency and Saving Energy 

Improved Climate Protection with Energy-Saving Products.

FCC / TCB Approvals
FCC / TCB Approvals 

Secure FCC Approval for Your Products with TÜV Rheinland.

G3-PLC
G3-PLC 

Certification of the correct implementation of G3-PLC specifications.

In-Vitro Diagnostic Devices (IVD)
In-vitro-Diagnostic (IVD)  

We Can Test and Certify Your Quality Management System and Products.

IP500
IP500 

Certification for interoperable IP500 communication modules and products.

KNX
KNX 

Certification testing services for KNX devices and systems.

LoRa Alliance Certification
LoRa Alliance Certified Program 

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

Medical Device (tested)
Tested Medical Device 

Market Your Products More Effectively with Voluntary Certification.

NFC Certification
NFC Certification 

Testing your NFC-enabled devices to guarantee the best performance.

OpenADR
OpenADR 

Correct functionality and performance of OpenADR products.

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

Conformity Evaluation for Radio Installations and Telecommunications Products.

Smart Grid Product Testing
Smart Grid Product Testing  

Ensure Your Products Work in the Smart Grid.

Wi-SUN
Wi-SUN 

Certification testing for Wi-SUN applications.

Wireless Testing
Wireless Testing 

Make Wireless Global Testing and Certification Easy with TÜV Rheinland.

ZigBee® Certification
ZigBee® Certification 

Testing and certification services for your product’s future success.

Contact

Get in contact with us!

Get in contact with us!