Medical Device Testing and Auditing available in the following languages:

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Medical Device Testing and Auditing available in the following languages:

or select your TÜV Rheinland region / country website:

Download extensive material for testing and certification of your medical devices

Events & Downloads

Perfectly informed: our whitepapers

Whitepaper: IEC 60601-1

Learn more about safety standards for medical electrical equipment.

Whitepaper: IEC 61010-1

Successful in international markets with electrical equipment for measurement, control and laboratory use.

Whitepaper: MDR

How does the European MDR affect chemical substances in medical devices?

Perfectly prepared: Questionnaire and application documents for your certification

General documents

MDR

IVDR

Perfectly updated: latest news

Flyer: Biological, Biochemical and Chemical Tests of Medical Devices

Flyer: Biological, Biochemical and Chemical Tests of Medical Devices

Flyer: UKCA marking for medical devices

Flyer: UKCA marking for medical devices

Medical Devices Regulatory Newsletter 05/2023

Medical Devices Regulatory Newsletter 05/2023

Official Journal of the European Union (L19)

Official Journal of the European Union (L19)

Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices

Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices