Requirements and Implementation of Regulation (EU) 2017/745
The requirements of the MDR have applied to all medical devices sold in the EU since May 26, 2021. The aim of this regulation is to harmonize the regulatory review and approval process for medical devices across all EU member states and to enhance patient safety.
On March 15, 2023, Regulation (EU) 2023/607 was formalized. With this amending regulation, medical device manufacturers now have more time to certify their products. However, the extension of the transition period is subject to clear conditions.
Many new and amended requirements raise a number of questions, such as the classification of medical devices, the requirements for evidence regarding safety and performance, as well as the many amended requirements for technical documentation, clinical evaluation, or requirements for post-market surveillance, EUDAMED, UDI, etc.
Anyone working in the medical device industry should be familiar with and understand the various hurdles of the MDR, as daily work is based on this regulation.
In this interactive seminar, you will learn about the various requirements of the MDR and receive useful tips on how to implement them in your company.
- Content
- Legal Framework
- Responsibilities and Obligations of Economic Operators
- Requirements for a Quality Management System
- Requirements for a Risk Management System
- Technical Documentation for Medical Devices
- Classification of Medical Devices
- Clinical Evaluation
- Conformity Assessment Procedures and CE Marking
- Post-Market Surveillance (PMS)
- EUDAMED
- Person Responsible in accordance with Article 15 (PRRC)
- Your Benefits
- You’ll gain an up-to-date overview of regulatory requirements and the MDR.
- You’ll learn how to implement the new requirements within your organization.
- You’ll understand the relationships and interactions between different departments and grasp the big picture.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Professionals or career changers
- Regulatory affairs specialists
- Risk management specialists
- Project managers
- Employees from various departments who want to better understand the big picture and the interfaces with other departments
