Join our latest Webinar about EUDAMED. Sandra Ferretti, CCO at Obelis Group will walk you through all the challenges related to Actor and Device Registration!
Person Responsible for Regulatory Compliance (PRRC)
Requirements for Legacy Devices under the MDR as of May 26, 2021
In this article we give you an overview about the MDR requirements that a legacy device must met to be considered compliant.
Person Responsible for Regulatory Compliance (PRRC) Seminars (MDR/IVDR)
Two-day seminar delivered by top industry experts! Aimed at providing basic knowledge and concepts to those who are interested in the role of Person Responsible for Regulatory Compliance (PRRC).
Class I Medical Devices: Achieve MDR compliance in 9 steps
The new factsheet published by the European Commission shows the necessary steps for compliance. Find out how to achieve MDR compliance in 9 steps.
REGULATORY BREAKFASTS
Obelis Academy, in collaboration with Norway Health Tech, present a series of Regulatory Breakfasts.
Along these courses, the experts will be addressing the most important topics to be prepared to meet the MDR deadline, with the possibility to book one-on-one meetings with the industry leaders to discuss your specific questions.
Powered by TEAM-PRRC Association FREE PRRC WEBINAR
TEAM-PRRC Webinar, powered by TEAM-PRRC.
MDR DELAY: Do you understand the implications of this delay?
On the 24th of April 2020, Regulation 2021/561 was adopted and published, delaying the MDR by 1 year to May 26th 2021;
But what did this mean for Medical Device manufacturers?
Our FREE Webinar was to find out and hear about the MDR DELAY EXPLAINED – we covered the impact on:
Webinar: Person Responsible for Regulatory Compliance (MDR/IVDR)
Interested in The Medical Device Regulations? Read more about Obelis webinars on it.
SWEXIT OR NEW MRA?
If a “worst-case scenario” was actually to happen, Swiss manufacturers will have to meet third country requirements.
MDCG released Guidance on the role of the Person Responsible for Regulatory Compliance (PRRC)
Medical Devices Coordination Group have issued guidance on the new role of the EU Responsible Person under EU medical device and in-vitro device regulations.