Notified Bodies
Independence and Neutrality
DEKRA Certification: Notified & Approved 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 UK Ltd is a UK Approved Body (8505) for medical devices.
- DEKRA Certification B.V., DEKRA Certification GmbH and DEKRA Certification UK Ltd certify quality management systems according to EN ISO 13485 for manufacturers, distributors, and supply chain companies in the medical device sector.
certification.uk@dekra.com
med.certification.de@dekra.com
medical.global@dekra.com