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 the certification body. Admission to the exam is granted upon a minimum attendance of 80%.

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

In the examination participants prove their knowledge in the following areas:

  • CE-marking process for medical devices
  • Regulations and standards
  • Conformity assessment procedure
  • QM-System according to EN ISO 13485 vs EC-Verification
  • Technical documentation for medical devices
  • Risk management according to ISO / EN ISO 14971
  • Responsibilities, routes, deadlines and responsibilities in the monitoring system for the reporting of incidences and of safety-relevant measures in this field using examples from  the EU, USA and Canada.

or, optionally

  • Legal fundamentals of medical devices law
  • European medical devices monitoring and reporting system and the Medical Product Safety Scheme regulation
  • Safety Representative for Medical Products in practical operation
  • Regulatory frameworks for medical devices (CE)
  • Post market surveillance of medical devices

„Responsible Person for Regulatory Compliance Medical Device Regulation (TÜV)“ are familiar with the area of responsibility and the duties of a responsible person in production, technical documentation, market surveillance and incident reporting as well as  test products. In the context of production processes, they can check the conformity of the medical devices in a final inspection in accordance with the quality management system. They ensure that the technical documentation and the declaration of conformity for the entire lifecycle are always up-to-date. They are responsible for making sure that the obligations of market surveillance (post market surveillance) and the related reporting and notification requirements (monitoring) are met.

Currently implemented in:Germany