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Certification and Auditing 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

Approvals for Greater China
CCC, NAL, CEL Approvals for Greater China 

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

CB Procedure
CB Scheme 

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

EN ISO 13485 Certification
Certification According to EN ISO 13485 

Validating Your Quality Management System.

ISO 14001 Certification
ISO 14001 

We certify your environmental management systems according to ISO 14001.

Contact

Get in contact with us!

Get in contact with us!