Your insight to: confinis and its partners – work in progress regarding MDR implementation
- September 4, 2018
- Posted by: confinis
- Category: Regulations
Today, confinis and its partners*, want to start sharing more insight about the work in progress when it comes to implementation of the European MDR. We want you, being a part of the confinis community, to get more insights about how we prepare and engage when it comes to generating solutions and way forward regarding the new requirements. We believe in a collaborative approach to gather various input and consolidation in engaging discussions with the goal to come to a common conclusion to take next steps. We started to act and look forward in taking this further, also for you to benefit!
What will you see?
Periodically, we will share relevant information to following topics:
– Overview of key changes MDD – MDR
– Effects of MDR on QMS
– Transition Periods for MDR
– Important Definitions
– Classification of MDs under MDR
– Conformity assessment procedures and premarket scrutiny
– Clinical data – clinical evaluation & clinical investigations
– EUDAMED, SRN and UDI
– Technical Documentation of MDs under MDR
– General Safety and Performance Requirements
– Postmarket requirements & vigilance
– Combination products under MDR
– Notified Body audits incl. unannounced audits
– Economic operators
Today, to set the scene, we will provide you with an overview and reflection of the key changes looking at the MDD and MDR. The outline was compiled by Andrea Schütz-Frikart, FRIKART Engineering GmbH, a partner to confinis ag.
In the following weeks we will pick up the individual key changes and go into more detail regarding challenges, what we think is important and consider latest developments if applicable.
Did you start your MDR implementation with a Gap analysis? Let us know: firstname.lastname@example.org
We are ready for you to take action!
*partners to confinis: Frikart Engineering GmbH, MED-RAS GmbH, Bernd Juhre