ID No. 0000055721: Responsible Person for Regulatory Compliance Medical Device Regulation (TÜV)

The requested ID page is also available in the following languages: German
Certification Program Title:Responsible Person for Regulatory Compliance Medical Device Regulation (TÜV)
Admission Requirements:

Successful participation in the TÜV Rheinland Academy’s qualification „Responsible Person for Regulatory Compliance Medical Device Regulation (TÜV)“, recognized by PersCert TÜV, with the individual seminars

  • CE-marking process for medical devices (8 teaching units) (seminar no. 09455)
  • Regulatory requirements for medical devices (8 teaching units) (seminar no. 09516)
  • Technical documentation for medical devices (8 teaching units) (seminar no 09361)
  • Risk management according to ISO / EN ISO 14971 (8 teaching units) (seminar no. 09471)
  • No fear of reportable events with medical devices (8 teaching units) (seminar no. 09469)
    or alternatively
  • Safety representative for medical devices basic course (8 teaching units) (seminar no. 09517)
  • Post market surveillance of medical devices (8 teaching units) (seminar no. 09517)

all of which have to be completed within a maximum period of three years. Admission to the examination is granted upon a minimum attendance of 80% of the 48 teaching units.

Examination Components:
  • Written examination (multiple choice)
Required Competencies:

In the examination, candidates prove their knowledge in the following areas:

  • CE-marking process for medical devices
  • Provisions and standards
  • Conformity assessment procedures
  • QM system according to EN ISO 13485 vs EC verification
  • Technical documentation for medical devices
  • Risk management according to ISO / EN 14971
  • Resonsibilities, means, deadlines and responsibilities in the vigilance system
  • European Medical Devices Vigilance and Reporting System and the Medical Device Regulation
  • Regulations for medical devices (CE)
  • Post market surveillance of medical devices

Responsible Persons for Regulatory Compliance Medical Device Regulation (TÜV) are familiar with the remit and duties of a responsible person in production, technical documentation, market surveillance and incident reporting as well as for test products. In the context of the production process they can verify the conformity of the medical devices according to the quality management system in a final inspection. They ensure that the technical documentation and the declaration of conformity are always up-to-date throughout the entire lifecycle. They are responsible for the obligations regarding market supervision (post market surveillance) and the related reporting and notification requirements (vigilance).

Currently implemented in:Germany