A comprehensive guide to EU MDR 2017/745: Classification, GSPR, Clinical Evaluation (CER), and Post-Market Surveillance
Sub Category
- Industry
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Objectives
- Distinguish between the MDD Directive and the MDR Regulation to understand the new direct legal enforcement across EU member states.
- Apply Annex VIII risk-based classification rules, including specific criteria for invasive, active, and software devices (Rule 11).
- Define the legal responsibilities of Economic Operators, including Manufacturers, Importers, Distributors, and Authorized Representatives.
- Construct a Clinical Evaluation Report (CER) that meets strict new evidence standards, moving beyond the "equivalence" route.
- Validate compliance with General Safety and Performance Requirements (GSPRs) in Annex I, replacing the old Essential Requirements.
- Understand the 6 modules of EUDAMED
Pre Requisites
- A basic understanding of the medical device industry or product lifecycles is recommended.
- Familiarity with Quality Management Systems (ISO 13485) is helpful but not mandatory.
- No prior legal expertise is required; the course breaks down complex regulations into clear concepts.
FAQ
- Q. How long do I have access to the course materials?
- A. You can view and review the lecture materials indefinitely, like an on-demand channel.
- Q. Can I take my courses with me wherever I go?
- A. Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don't have an internet connection, some instructors also let their students download course lectures. That's up to the instructor though, so make sure you get on their good side!
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