European Union (EU) MDR

This course has been designed to understand European directives, CE marking and guidance documentation.

Course Benefits
Participants will understand EU directives and related directives (objectives, history, structure, purpose).

Who Should Attend?
The target audience for this course consists of executives, top management who work in quality (QA/QC), compliance / regulatory affairs, manufacturing (operations), medical device manufacturers who desire to export to Europe.

Topics Covered

• Conformity assessment paths
• Requirements for safety / health / environment / consumer protection
• Medical device classification systems / Medical device classification in the EU (by directive)
• Risk Management and its relation to medical device directives
• The application and differences of the directives that cover medical devices
• European approval process and how to plan
• The conformity assessment paths in the directives
• EN medical device safety assessment procedure.
• Annex II – Full Quality Assurance System
• Relationship to other product directives
• EN ISO 9004-1 using medical device guidance documents (EN 50103, EN 928), and combining it with ISO 9001, ISO 13485
• Compare & Contrast EU & FDA Procedures and Requirements
• Development, aims, and implementation of medical device directives in the EU
• EU Directives overview & their impact: (developing/marketing new medical device products) * Active Implantable Medical Device Directive (AIMDD) * Medical Device Directive (MDD) * In Vitro Diagnostic Device Directive (IVDD).
• EU medical device directives - key relationships / vigilance program
• Compliance Options by Device Class
• Key definitions / terms, conformity assessment procedures, QSR
• Guidance documentation (directives implementation
• Technical files and Design Dossiers
• Using harmonized standards to satisfy the Essential Requirements

Prerequisites:

Medical Device background, those in quality / regulatory affairs responsible for preparing / working with CE Marking Audits, those in U.S. and Canadian organizations that are new to the European Union market; those performing risk analysis / design for medical devices (development); and those companies in preparation of their own private label of medical device (marketed in Europe).

Please Note: Price includes materials, and certificate of attendance