Author: Criterion Edge Writers
Concerns and frustration surrounding the implementation of Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) were voiced in early May at MedTech Europe’s 2022 Forum in Barcelona. Two notable sessions that discussed MDR and IVDR implementation were reportedly lively and filled to capacity. The chairs of these sessions, Marc Pierre Möll, CEO of BVMed, and Oliver Bisazza, MedTech Europe’s Director General of Industrial Policies and External Affairs, shared their reflections on these discussions in Barcelona and the current impacts of MDR in an interview with MedTech Insight.
COVID-19 layered on top of Brexit has created unique challenges and opportunities in the EU and UK medtech regulatory markets. Elemed’s Elena Kyria offers advice to help jobseekers and recruiters navigate the current turbulent waters and beyond.
There are some golden career opportunities for medtech regulatory candidates right now. In this preview article to a longer interview piece, Elena Kyria of Elemed explains what these are and how firms with open positions can respond.
The EU has the green light to adopt and list standards that will be recognized under the MDR and IVDR. But there will be no escaping the impact of the delays, especially for the IVD sector.
Author: Dr. Suzanne Broussard
One of the recent announcements in the everchanging medtech sector is that the newest European database on medical devices (Eudamed 3) will roll out modules as they become functional. Eudamed 3 is the cornerstone for the new medical device regulations (MDR) and in vitro device regulations (IVDR) and is by all accounts an ambitious project.
The version of Eudamed currently in use (Eudamed2) is a secure web-based portal designed to conduct effective market surveillance on medical devices through information exchange between competent Authorities and the Commission.
Eudamed 3 will be dramatically different when it eventually rolls out. Eudamed 3 is designed to be multipurpose and function as a:
The original intention was that the newest Eudamed database would launch at the same time as the original MDR date of application. However, challenges in preparing the new updated system forced the delay by 2 years. Under this delay, Eudamed 3 will roll out on 26 May 2022.
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In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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