Testing and Certification Services Provided by TÜV Rheinland – Experience you can Trust
Medical devices are very diverse. This product group includes stethoscopes to a wide range of implants like pacemakers to joint prostheses, and beyond to in vitro diagnostic medical devices (IVD), used to collect and analyze blood, tissue or cell samples. Medical devices are used extensively throughout the diagnosis, monitoring, treatment and prevention of medical conditions, therefore are subject to specific regulations in markets worldwide.
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.
|Testing of medical devices during the COVID-19 pandemic||TÜV Rheinland took immediate measures to ensure the continuation of services during the COVID-19 pandemic. We have also expanded our capabilities in key markets to support the persisting needs. We offer expert testing for medical devices from community masks, thermometers, blood pressure monitors and PPEs to intensive care equipment such as ventilators and countless more.|
|Testing of medical devices according to the IEC 60601 series of standards||We offer testing and risk assessment for electrical medical devices based on the IEC 60601 standard series.|
|Non-active Medical Device Testing||Certification as “Geprüftes Medizinprodukt” (GM Mark) demonstrates your commitment to product excellence. Non-active medical devices (Class I) benefit from securing a GM mark to achieve differentiation in the market.|
|Testing of other products in the medical field||We test and certify wheelchairs, rollators, scooter-mobiles, hospital beds and patient lifts, medical lamps/lighting products, light intensity and spectral light distribution, and personal eye protection.|
|Wireless||We test and certify IoT medical technology – for treatment quality and patient safety|
|Other (partial) tests for medical devices||We test your medical device for electromagnetic compatibility (EMC), ergonomics, usability and much more. Contact us for specific details.|
|EN ISO 13485 certification||The international standard EN ISO 13485 is the standard for quality management systems in the medical device sector. We review your quality management in areas such as design/development, production, customer service and assembly of medical devices.|
|ISO 15378 certification||We review and certify your quality management system for the production of primary packaging for medicinal and pharmaceutical products based on the applicable standard ISO 15378.|
|ISO 9001, ISO 14001 and ISO 27001||We certify your quality management system, environmental management or information security.|
|Assessment and certification of companion diagnostics||We support pharmaceutical companies and CDx manufacturers with meeting the requirements of the new IVDR.|
International Approvals of Medical Devices
In many respects, globalization has made the world smaller. However, there are still many national laws and individual regulations that apply to the marketing of medical devices on international markets. With our solid international reputation and nearly 150 years of experience as a global independent testing, inspection and certification organization, we help you access new markets with TÜV Rheinland's Market Access Services.
|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.
Market Access Worldwide
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.
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.
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