4 – 5 December 2018
Under the EU approach there is no possibility of grandfathering existing products and ultimately all legacy devices (CE Marking under the current MDD) will need to meet the full requirements of the new EU MDR by 2020, with a possible three-year grace period under strict conditions.
Registering for this workshop will have hands-on case studies exercises including:
- the impact of the changes on legacy products
- what no "grandfathering" means more conformity assessments
- classification changes on legacy devices
- labeling changes for legacy devices – new requirements and symbols
Virtual Program: Key Challenges in Preparing for EU Medical Device Regulation (MDR)
6 December 2018
11:00 – 4:15 pm EST
Experience in-person training without the travel. This virtual program focuses on key areas requiring significant effort to evaluate and update to maintain access to the European marking such as understanding clinical data expectations, generating clinical evaluation reports, updating technical documentation and preparing for enhanced post-market requirements.
Topics that will be covered:
- the impact of the new clinical requirements on clinical evidence
- new expectations of clinical evaluation reports
- the technical documentation required to demonstrate compliance
- enhanced post-market expectations