Notified Bodies
Independence and Neutrality
DEKRA Certification: Notified Bodies for Medical Devices.
- DEKRA Certification B.V. (ID 0344) and DEKRA Certification GmbH (ID 0124), as Notified Bodies, conduct conformity assessments in line with Directive 93/42/EEC and EU Regulations 2017/745 & 2017/746 for companies placing medical devices on the market
- DEKRA Certification B.V. and DEKRA Certification GmbH and certify quality management systems according to EN ISO 13485 for manufacturers, distributors, and supply chain companies in the medical device sector.