In-vitro-Diagnostic Medical Device Regulation (IVDR)
As a Notified Body, we are involved in the conformity assessment procedure for your in-vitro diagnostics to ensure fast and legally compliant access to the EU market.
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Certification of medical devices
DEKRA Certification is a notified body and certification body for medical devices
The market for medical devices is characterized by fierce international competition, numerous regulations and constant change. Takeovers lead to shifts in the competitive situation, and innovative strength and speed are decisive for market success. In these changing times, it is equally important to focus on your strengths and specialize.
As a notified body with the identification number 0124, we are involved in the conformity assessment procedure for medical devices in accordance with Regulations (EU) 2017/745 and (EU) 2017/746 for companies that place medical devices on the market. As an accredited certification body, we also certify quality management systems in accordance with EN ISO 13485 in companies that manufacture or distribute medical devices or are part of the supply chain.
ISO 13485 Certification
The international, process-oriented ISO 13485 standard forms the basis for the certification of quality management systems in companies that manufacture or distribute medical devices - or are involved in their manufacture as part of the supply chain.
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Medical Device Regulation (MDR)
DEKRA is a Notified Body for Regulation (EU) 2017/745 on medical devices.
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Here you will find all downloads for medical devices!
Downloads
med.certification.de@dekra.com