In-Vitro Diagnostic Devices (IVDR)
The new regulation of in-vitro devices focuses on a new classification of four risk classes, a more precise description of their clinical performance
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Medical Device Services
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.
- 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, 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 and auditing for ISO 13485.
The FDA has approved DEKRA to take part in the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. The ASCA program allows accredited, independent laboratories to assess premarket medical devices for compliance with FDA-recognized standards. By enhancing product reviewers’ and manufacturers’ confidence in testing results, the ASCA program decreases FDA requests for additional information on testing methodology. The end result is a more efficient review process and faster access to markets.
Medical Device Regulation (CE MDR)
In May 2017 the new Regulation on Medical Devices (CE Certification MDR 2017/745) came into force in order to replace the current MDD & AIMDD
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Medical Device Single Audit (MDSAP)
The Medical Device Single Audit Program is designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictions
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ISO 13485 Certification
For the processes involved in the development, production, design, and servicing of medical devices, companies have to implement a quality management system
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IEC 60601-1-2
Medical Directive testing standard IEC 60601-1-2 requires companies to revisit their test strategies of EMC devices to be fully compliant.
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UKCA Marking
With the UK leaving the EU, medical device manufacturers that want to place their products on the British market will need to comply with the new UKCA marking
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