Medical Device Law Foundation Course - Regulatory framework according to MDR
This seminar introduces you to the European Medical Device Regulation (MDR, 2017/745). The efficient implementation of these complex legal requirements ensures that your medical devices are safe and perform as intended. You will learn about the necessary steps for CE marking, including classification, the conformity assessment procedure, and general safety and performance requirements.
Additionally, the course covers the practical requirements for Medical Device Consultants and the Person Responsible for Regulatory Compliance (PRRC). You’ll gain an overview of the responsibilities of manufacturers and notified bodies, as well as the key stakeholders in Germany.
Since the MDR introduces numerous changes at the European level that impact German medical device law, national legislation has been adapted accordingly. Among these changes is the replacement of the Medical Devices Act (MPG) with the Medical Devices Implementation Act (MPDG). This seminar provides a foundational overview of the new German medical device legislation.
- Structure and principles of the MDR (Medical Device Regulation - 2017/745) in Europe
- Basics of CE marking: classification, conformity assessment procedures, essential safety and performance requirements, declaration of conformity, application of harmonized standards, transitional provisions
- Key terms: clinical evaluation, clinical investigation, risk management, conformity assessment, classification, technical documentation, and vigilance
- Overview of German medical device law
- Alignment with EU law through the Medical Devices EU Adaptation Act (MPEUAnpG) and Regulation (MPEUAnpV)
- Medical Devices Implementation Act (MPDG) and related national regulations
- Responsibilities of different economic operators: manufacturers, authorized representatives, importers, and distributors
- Introduction of the Person Responsible for Regulatory Compliance (PRRC) under Article 15 MDR and its link to the Medical Device Consultant according to §31 MPG / §83 MPDG
- Interpretative aids and guidance documents on national and international regulations:
- European guidance documents (MDCG – Medical Device Coordination Group)
- International guidance (IMDRF and CAMD)
- Gain a compact and structured overview of the complex legal requirements of the MDR.
- Understand the essential steps for market access in Europe.
- Know your responsibilities and obligations under the Medical Device Regulation.
- Executives of medical device manufacturers
- Employees in Regulatory Affairs and Quality Assurance
- Personnel seeking to understand current medical device regulations
- Suppliers of medical devices
- The seminar content reflects the latest revisions and harmonizations.
- Covers internationally valid standards and is suitable for international implementation.
- Part of a modular training program. Completion of this course can be credited toward the following recognized certifications:
- Manager Regulatory Affairs International – TÜV
- Safety Expert Active Medical Devices – TÜV
- Safety Expert Non-Active Medical Devices – TÜV
The seminar price includes the professional reference book “Medical Device Regulation (MDR)”.
English
Participants will receive a certificate of attendance issued by TÜV SÜD Academy.
This training is being operated by TÜV SÜD Akademie GmbH in Germany. The General Terms and Conditions as well as the Privacy Notice of TÜV SÜD Akademie GmbH apply. In case of any questions, do not hesitate to contact us.