Course description
The Overview of Medical Device Regulation (MDR) One-Day Course provides participants with a comprehensive introduction to the European Union's Medical Device Regulation (MDR 2017/745). This course is designed to familiarize stakeholders with the regulatory framework, requirements, and implications of MDR for medical device manufacturers, importers, distributors, and other industry professionals. Participants will gain insights into key changes from the previous Medical Device Directive (MDD) and learn how to navigate compliance challenges under MDR.
Benefits:
- Gain a comprehensive understanding of MDR requirements and implications for medical device stakeholders.
- Enhance compliance readiness and strategies for navigating regulatory challenges.
- Improve knowledge of market access requirements and product lifecycle management under MDR.
- Network with industry peers and regulatory experts to exchange insights and best practices.
Upcoming start dates
Suitability - Who should attend?
Who Should Attend:
- Regulatory affairs professionals, quality assurance managers, and compliance officers in medical device companies.
- Product development engineers, project managers, and legal advisors involved in medical device regulatory compliance.
- Consultants, auditors, and stakeholders seeking to understand the implications of MDR on market access and product lifecycle management.
Outcome / Qualification etc.
Course Objectives:
- Understand the scope and objectives of the Medical Device Regulation (MDR 2017/745).
- Learn the classification system for medical devices and in vitro diagnostic medical devices (IVDs) under MDR.
- Explore the conformity assessment procedures and requirements for placing devices on the market.
- Gain insights into labeling, packaging, and post-market surveillance obligations under MDR.
- Understand the roles and responsibilities of economic operators (manufacturers, authorized representatives, importers, distributors).
- Learn about clinical evaluation, performance evaluation, and clinical investigations as per MDR requirements.
- Discuss the transition timelines and challenges from MDD to MDR compliance.
Certification:
Participants will receive a certificate of completion upon fulfilling the course requirements, demonstrating their understanding of the Medical Device Regulation (MDR) framework and requirements.
Training Course Content
Morning Session:
- Introduction to Medical Device Regulation (MDR): Objectives, scope, and key changes from MDD.
- Overview of regulatory requirements: Classification, conformity assessment routes, and notified bodies.
- Roles and responsibilities of economic operators: Manufacturers, authorized representatives, importers, and distributors.
- Labeling and packaging requirements under MDR.
Afternoon Session:
- Post-market surveillance and vigilance obligations: Reporting requirements and PMS strategies.
- Clinical evaluation and performance evaluation requirements under MDR.
- Transitioning from MDD to MDR: Timeline, challenges, and strategies for compliance.
- Case studies and practical examples: Applying MDR requirements to real-world scenarios.
- Q&A session and knowledge assessment: Reviewing key concepts and addressing participant queries.
Course delivery details
Course Format:
- Duration: One day (8 hours)
- Delivery: Instructor-led training, available in both in-person and virtual formats.
- Interactive Learning: Case studies, group discussions, and Q&A sessions to reinforce learning.
- Comprehensive Materials: Participants will receive course handouts, regulatory texts, and a certificate of completion.
Expenses
Class Size and price: Up to 15 delegates £2,225.00
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