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Product testing

QM System Certifications

International Approvals

Our Services for Medical Devices at a Glance

Our years of experience, extensive knowledge and experts sitting worldwide are here to offer you a wide range of testing and certification of medical devices. Bundle testing and certification for your medical devices with market access services to European and international markets with a single source provider.

The Medical Device Single Audit Program (MDSAP) gives you the option to meet the quality management requirements for the approval of your medical devices in the participating countries of Australia, Brazil, Japan, Canada and the USA with only one single audit.

National Approvals Worldwide

We support the approval of your medical devices worldwide. Take advantage of our experience – Opt for a comprehensive one-stop service. With staff familiar with local requirements in each respective country, our experts can advise you on approval procedures suited to your product and needs.

  • Asian Medical Device Directive (AMDD) for ASEAN countries
  • Registered Conformity Assessment Body (CAB) under the Malaysian Medical Devices Act 2012
  • PMD Act Japan
  • SFDA approvals (Saudi Arabia)
  • Taiwan’s Technical Cooperation Program (TCP)
  • CB Scheme (IECEE)
  • Support for access to the Ukrainian market
  • Support for access to the Russian market
  • Review of market requirements

Market Access for Europe

Based on old directives Based on new regulations
Active Implantable Medical Devices (AIMD) The currently still valid EC Directive 90/385/EEC contains the requirements for active implantable medical devices for the European market. European Medical Devices Regulation (MDR) 2017/745

European Medical Devices Regulation (MDR) 2017/745


As Notified Body for conformity procedures and certifications according to the MDR, we provide services throughout your transition to the new regulation and with the re-certification of your medical devices.
Active and Non-Active Medical Devices (MDD) valid EC Directive 93/42/EEC contains the requirements for active and non-active medical devices for the European market
In Vitro Diagnostic Medical Devices (IVDD) We are a Notified Body for the Directive 98/79/EC on in vitro diagnostic medical devices and will perform the testing and certification of your quality management system and products. EU Regulation on In Vitro Diagnostics (IVDR) 2017/746

As Notified Body for conformity assessment procedures and certifications according to IVDR, we provide services throughout your transition to the new regulation and the re-certification of your in vitro diagnostic medical devices.

Access to the North American Market

As a nationally recognized testing laboratory (NRTL), TÜV Rheinland can help you with a cTUVus certification to get your product faster on the North American market, which is considered particularly attractive due to its large size and purchasing power. To ensure a high product quality, the governments of the U.S.A. and Canada have passed clearly defined regulations that must be met by electronics, other products and equipment before they are approved for sale or use in the workplace. TÜV Rheinland has the expertise and facilities to offer testing and certification of your products for the North American market.

Learn more about our medical device services.

Learn more about our medical device services.

We will provide you with a non-binding tailored offer.