Medical Device Certification
Assessment and certification services for the medical device industry
As a medical device manufacturer, you must navigate your way through a complex landscape of regulatory requirements before you can sell your devices on the international market. International standards and European regulations are there to ensure that products are safe and function accordingly.
Why DEKRA for Medical Device Regulatory Services
- Two European Notified Bodies: DEKRA Certification GmbH (NB 0124) and DEKRA Certification B.V. (NB 0344) to provide services to companies involved in the design, manufacturing, and distribution of medical devices, including high-risk and innovative medical devices and in-vitro diagnostic medical devices.
- Recognized auditing organization for MDSAP: The Medical Device Single Audit Program (MDSAP) is designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictions. DEKRA is a recognized auditing organization for MDSAP.
- Designated Approved body (8505) in the UK to provide UKCA marking services.
- Globally recognized certification body: With a global network of offices and state-of-the-art laboratories, we provide services and certifications that are needed for a worldwide market access including Europe, Taiwan, the USA, the UK, Canada, Brazil, and Australia.
DEKRA is active almost everywhere in the world and the members of our medical device team have extensive expertise in a wide array of medical and in vitro devices.
In addition to being a designated European Notified Body, we are also a recognized MDSAP auditing organization. We offer all the essential services to manufacturers of medical devices: MDR, IVDR, IVDD, MDSAP, UKCA and auditing for ISO 13485.
CE Certification IVDR (EU) 2017/746
In-vitro-Diagnostic Medical Device Regulation (IVDR)
Quality Management System
ISO 13485 Certification
CE Certification MDR (EU) 2017/745
Medical Device Regulation (MDR)
Standardizing how we audit medical devices on a global scale
Medical Device Single Audit (MDSAP)
UKCA marking will replace CE marking in Great Britain. DEKRA is in the process to become a UK Approved Body for medical certification.
UKCA Marking for Medical Devices