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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.

Medical Device Safety and Testing at a Glance

Medical Device Regulation (MDR) 2017/745

Start here. - Check the newest regulations, certificate transition dates, and common FAQs for in vitro diagnostic and medical device requirements. Are you prepared for EU, US and key market approval?

New Regulations for Medical Products

pdf New IVDR 1 MB Download
pdf MDR / IVDR declaration of interest 92 KB Download
pdf Regulation (EU) 2017/745 1 MB Download
pdf Regulation (EU) 2020/561 522 KB Download

Our portfolio

EN ISO 13485 Certification
EN ISO 13485 certification of QMS for medical devices | TÜV Rheinland  

Certify your Quality Management System (QMS) for medical devices

Tested Medical Device
Non-Active Medical Device Testing 

Increase your competitive edge and certify your non-active medical device products.

RoHS Compliance Testing
RoHS 

We test electrical and electronic devices according to the international standards applicable to your products.

EU Medical Devices Directive MDR 2017/745
EU Medical Device Regulation MDR 2017/745 

Supporting access to European markets for medical devices under MDR 2017/745.

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 

We provide comprehensive approval and certification services for fast entry to Greater China market.

Acoustics Testing and Measurement
Acoustics Testing and Measurement 

Audiological Testing and Vibration Measurement.

In Vitro Diagnostic Medical Device Regulation (IVDR)
In Vitro Diagnostic Medical Device Regulation (IVDR) 

Comprehensive services to ensure IVDR compliance for your in vitro medical devices.

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

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

Green Product Mark
Environmental Label Green Product Mark 

Clearly label sustainable products with TÜV Rheinland’s Green Product Mark.

Artificial Intelligence for Products
Artificial Intelligence for Products 

A guide for understanding the impacts of the EU AI ACT on Products

Electromagnetic Compatibility (EMC)
Electromagnetic Compatibility (EMC) Testing 

From medical products to wireless devices and beyond, our EMC testing services keep you compliant.

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