October 18, 2018 - October 18, 2018
Date: 18 October 2018
Location: Amsterdam Area
Language: Presentations will be in English
Cost: Regular: € 875.-
The EU-MDR introduces a new view on technical documentation, that is broader than the current view on technical files and design dossiers (class III). It differentiates between data needed prior to market access (MDR annex II) and post market data (annex III). With all the changes one can only conclude that all technical files and design dossiers need to be revised to match the EU-MDR requirements.
This training focusses on practical guidance to fulfill the technical documentation requirements in the EU-MDR. It clarifies what is needed for annex II technical documentation that needs to be ready (and reviewed by Notified Bodies as appropriate) before the market introduction of the new product. It will clarify the approaches and extent of data collection in the post-market phase. And it will provide insight into the requirements for Periodic Safety Update Reports and for Summary of Safety and Clinical Performance that will be part of the growing technical documentation for the products over its lifetime. The day will be filled with discussions and case studies.
- Annex II technical documentation – pre-market
- Annex III technical documentation – post-market
- Regulatory Product Life Cycle concepts, embedding PMS and PMCF
- PSUR & SSCP requirements
- Case studies
- Questions & Answers
- Evaluation of the Course and Closing
Learn to structure data and build technical documentation under MDR
Understand the full impact of the new EU-MDR on PMS and PMCF principles in continued market approval
Know how to apply PSUR and SSCP
Understand how to build and use checklists, tools, and templates
Introduction to the course
Introduction to the MDR
The new General Safety and Performance Checklist
Discover the extended requirements of the GSPR checklist versus the ER checklist (includes exercise)
Differences in MDR for Technical Files and QMS requirements
Determine the required update in Technical file for example product (includes exercise)
Changes in Clinical Evaluation Requirements
MS including PMCF
Discuss required update for the example product (includes exercise)
Labelling, IFU, Implant Card, UDI
Who should attend?
- RA department, creating technical files.
- R&D creating technical documentation