Are you ready for the EU Medical Device Regulation
The deadline for the EU Medical Device Regulation (MDR) is fast approaching.
The new Regulation which becomes fully applicable on May 26, 2021 aims to create a robust, transparent, and sustainable regulatory framework, and ensures high level of safety and health for patients and users.
The NDA team, led by Dr Tina Amini has identified several hurdles accompanying the new MDR that could challenge the process of making your medical device compliant with the updated requirements in time.
To help you prepare, Tina has created an easy to follow webinar series addressing each hurdle in turn.
Session 1 (Jan 14th): Introduction to EU Medical Device Regulation (MDR) and key changes
Session 2 (Jan 28th): Quality Management System update to meet MDR requirements
Session 3 (Feb 11th): Impact of EU MDR 2017/745 on Drug/Device Combination Products (DDCs)
Session 4 (Feb 25th): Clinical Evaluation of Medical Devices according to MDR
Session 5 (Mar 11th): Post Market Surveillance (PMS) & Periodic Safety Update Report (PSUR) requirements under the EU MDR
You can choose to attend one or more of the webinars.