Technical Documentation per (EU) In Vitro Diagnostic Device Regulation 2017/746
Identify and understand the key elements required in the in vitro diagnostic device technical file
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1.5-day of training | Virtual Classroom | $1200 pp
About the training
The European Union Medical In Vitro Diagnostic Device Regulation– Regulation (EU) 2017/746 (or EU IVDR) – entered into force on May 26th, 2017. GMED North America has designed a comprehensive training course to help companies get ready for their application to obtain and/or maintain CE marking for their medical in vitro diagnostic device product(s) and:
- Gain an understanding of the changes introduced by EU IVDR requirements;
- Assess the impacts of those changes on their organizational and structural activities.
REQUIRED LEVEL
Good knowledge and previous implementation of the Directives 98/79/EC.
Tom Patten IVD International Manager
Tom Patten is the IVD International Manager at GMED, with broad experience across the in-vitro diagnostics sector. His background includes laboratory work, product development, and R&D for molecular oncology devices, as well as seven years of notified body experience. Tom contributed to the successful designation of an IVD notified body under the IVDR (EU) 2017/746. In his current role, he supports manufacturers with global IVDR/IVD regulatory strategy, structured dialogue sessions, and international market access, bringing practical industry and notified body perspectives to his training sessions.
Who Should Attend
- Medical Device Manufacturers: Senior Management , Regulatory Affairs Managers and Quality Managers, R&D specialists, Development, Manufacturing and Marketing Managers
- Internal and external Auditors
- Importers
- Distributors
Learning Objectives
- Identify the component parts of technical documentation for establishing the conformity of in vitro diagnostic medical devices in line with the requirements of the European Regulation
- Identify the best practices for structuring the technical documentation in line with the expectations of certified bodies and competent authorities in charge of medical devices and market surveillance
Educational Resources
- Presentations
- Practical working sessions
- Course evaluation
Check out the Program
- Overview of regulations, guides and recommendations
- Identification of applicable requirements
- Content of the technical documentation (TD): structured approach
- Requirements for updating the technical documentation
- Management of the technical documentation: responsibilities and updating procedures
- EC Declaration of conformity: output data of the technical documentation
- Summary and Discussion with the trainer
Attendees Testimonials
Sr. Regulatory Affairs Specialist
Regulatory Affairs Specialist
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