Regulatory Affairs

Regulatory Affairs Services

The new regulation on medical devices (EU) 2017/745 poses great challenges to manufacturers and Notified Bodies. From 2020 (EU-MDR), CE marks can only be issued in accordance with these regulations.

Based on our scientific background, our close cooperation with the Institute for Orthopaedic Research and Biomechanics, Ulm University, Germany, and our huge testing experience we are a strong partner to support you in the following areas:

  • Consulting, preparation and maintenance of clinical evaluation reports according to MEDDEV 2.7/1 REV. 4, MDD (93/42/EEC) and MDR (2017/745)
  • Proof of compliance with the Essential Requirements (Annex I, MDD 93/42/EEC (2007)), CE Checklist
  • Consulting and preparation of risk analyses according to DIN EN ISO 14971 including analyses of applicable standards and guidelines
  • Advice on risk classification issues according to Annex IX to MDD 93/42/EEC