The EU Medical Device Regulation (MDR) is far more complex than the Medical Device Directive (93/43/EEC) it replaces and presents new challenges, including strict new requirements for Clinical Data, risk management, postmark surveillance, and supplier management.
QSG’s three-day course on the Medical Device Regulation 2017/745, with a focus on the requirements for Medical Device Manufacturers, provides comprehensive instruction on the EU MDR. It covers every aspect of the regulation and identifies key topics and changes, including economic operators and new roles associated with EU MDR, standard requirements that must be met by all manufacturers regardless of class, and the pre- and post-market requirements of conformity assessment.
In the course, you will receive a general overview of the Medical Device Regulation, the Implementation Timelines, Paths to CE Mark, and a deep dive into the significant articles that affect medical device manufacturers.
Included in the presentation is a copy of the MDR, a gap analysis template, and a sample of the General Safety and Performance Requirements checklist with highlights of significant differences from the MDD Annex I Essential Requirements Checklist.
Who Should Attend
The course is especially suitable for:
- Regulatory Affairs professionals who are not familiar with the European MDR
- Personnel working with Regulatory Affairs departments, e.g. top management, manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
At the end of this workshop, participants will be able to:
- Describe the objectives and structure of the EU MDR
- Identify the key differences between the requirements found in the existing directives and the EU MDR
- Explain the impact of the new EU MDR requirements on economic operators, including manufacturers
- Describe the different regulatory requirements through the life cycle of a device (e.g., premarket, design and development, product realization, and post-market)
- Identify the necessary steps to prepare an organization to transition to the EU MDR
- Plan a gap assessment to transition an organization to compliance
- Overview of the Medical Device Regulation
- Implementation timeline
- Paths to CE Mark
- Regulation structure overview
- Review of Significant Articles
- In-Depth Review and Discussion of Articles
- Review of Significant Annexes
- In-Depth Review and Discussion of Annexes
- Strategy for Deployment
- Tools and References