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As of December 2003, all IVDs marketed in the European Union (EU) must bear the CE Mark, and companies that market products in the EU must have a Authorized Representative based in Europe.
With offices in the United States and Europe, Medical Device Consultants, Inc. (MDCI) is well-qualified to help you move efficiently through the product development and regulatory processes in order to expedite product commercialization. MDCI can not only assist with U.S. regulatory needs, but can also help you meet requirements of the European IVD Directive.
KEY EUROPEAN IVD DIRECTIVE SERVICES
Strategic Planning
- Category/Classification
- Essential Requirements
- Quality System
- Notified Body Selection
- Risk Analysis
Consulting
- Technical File and Design Dossier Development and Review
- Labeling Review
Performance Evaluation
- Preparation of Clinical Summaries (literature)
- Clinical Investigational Plan
- Study Management and Monitoring
- Analysis of Results
Auditing
- Technical File and Quality System Conformance
Training
- General Requirements of the IVD Directive
- How to Comply with the IVD Directive
- Using the MDCI Ltd. Registered Address
- Ensuring compliance with the IVD Directive and national transpositions
- Representing the manufacturer to Competent Authorities and Notified Bodies
- Verifying that CE Mark is correctly affixed
- Managing vigilance reporting to Competent Authorities with required follow-up
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