Regulatory Specialist EU-MDR-IVDR - Online Class (exam included)

Course timeline

1. Technical Documentation for Medical Devices and IVD

   Module 1

   • Gain an overview of the key requirements of the EU MDR and IVDR regulations.
   • Understand the structure and essential content of technical documentation.
   • Explore key definitions and fundamental regulatory requirements.
   • Review the general documentation requirements outlined in Annex II of the MDR and IVDR.
   • Examine the specific requirements of MDR Annex II for medical devices.
   • Understand the specific documentation requirements of IVDR Annex II for in vitro diagnostic devices.
   • Learn how Annex VIII classification rules apply to medical devices and IVDs.
   • Apply your knowledge through practical exercises on intended use, product classification, and real-world regulatory scenarios, supported by practical tips and guidance.

2. General Safety- and Performance Requirements for Medical Devices and IVD

   Module 2

   • Gain an overview of the General Safety and Performance Requirements (GSPR).
   • Explore the GSPR requirements applicable to medical devices.
   • Understand the specific GSPR requirements for in vitro diagnostic devices.
   • Review the requirements of relevant standards that support MDR and IVDR compliance.
   • Learn practical methodologies and checklists for assessing and documenting GSPR compliance.
   • Apply your knowledge through practical exercises and real-world examples.

3. Requirements & processes for the development of medical devices & IVDs

   Module 3

   • Explore the EU regulatory framework for medical devices and in vitro diagnostic devices (IVDs).
   • Gain an understanding of the Global Harmonization Task Force (GHTF) regulatory model and its global perspective.
   • Review key US FDA Quality System Regulation (QSR) requirements, with a focus on design controls.
   • Understand the role of project management throughout the medical device development lifecycle.
   • Learn how quality assurance is integrated into the development process.
   • Explore the key stages and sub-processes involved in developing medical devices.
   • Follow the development journey from requirements management and product design through to design transfer.
   • Identify supporting processes that contribute to effective and compliant product development.
   • Discover useful resources, tools, websites, and sources of professional guidance.
   • Learn practical do's and don'ts, including important industry practices and common pitfalls.
   • Explore real-world examples and field experiences related to usability and process validation.

4. ISO 14971:2019 – Risk management for medical devices & IVDs

   Module 4

   • Understand the risk management requirements defined by the EU MDR and IVDR, along with relevant quality management standards.
   • Learn how to apply the principles of ISO 14971:2019 to medical device and IVD risk management.
   • Explore practical approaches for implementing and documenting an effective risk management process using the en.co.tec toolbox, including Risk management planning, Risk management activities and documentation, and Risk management reporting
   • Apply your knowledge through a practical exercise focused on creating and working with a risk management file.

5. Clinical testing & evaluation of medical devices and in-vitro diagnostics

   Lesson 05

   • Understand the regulatory framework governing clinical evidence, clinical benefit, and clinical performance evaluation.
   • Explore the clinical evaluation process and its role in demonstrating compliance with safety and performance requirements.
   • Identify the types of data required to support a clinical evaluation.
   • Understand the structure and key components of a Clinical Evaluation Report (CER).
   • Define clinical trials and examine the regulatory framework governing their conduct.
   • Understand the roles of the Ethics Committee and BASG in clinical trial oversight.
   • Review the documentation required for submitting clinical examinations.
   • Understand the purpose and key elements of a clinical trial protocol.
   • Explore the rationale behind conducting clinical trials.
   • Learn about clinical study design and the definition of appropriate study endpoints.

6. Labeling and UDI marking of medical devices and in-vitro diagnostics

   Module 6

   • Understand the MDR and IVDR requirements for Unique Device Identification (UDI).
   • Explore UDI concepts and its integration with quality management, production, and other business processes.
   • Understand the role of UDI within the EUDAMED database.
   • Review labeling requirements for packaging, medical devices, instructions for use, and accompanying materials.
   • Apply relevant labeling standards, including ISO 15223-1:2017 and EN ISO 20417:2021.
   • Understand language requirements applicable to medical device and IVD labeling.
   • Learn the key steps for implementing an effective UDI system.
   • Understand UDI issuing and labeling rules.
   • Learn how to assess, verify, and maintain barcode quality.
   • Explore master data management and data exchange requirements for UDI implementation

7. Post Market Surveillance (PMS)

   Module 7

   • Understand post-market surveillance (PMS) requirements under the EU MDR and IVDR.
   • Explore the manufacturer’s PMS system, including the post-market surveillance plan and Periodic Safety Update Report (PSUR).
   • Learn how to establish and maintain post-market surveillance documentation within the technical documentation.
   • Review relevant quality management requirements under ISO 13485:2016.
   • Understand the role of ISO 14971:2019 in integrating post-market information into medical device risk management.
   • Explore the guidance provided by ISO/TR 20416:2020 for effective post-market surveillance.
   • Apply the concepts through practical exercises and real-world examples.