July 14, 2022

Unpredictability of MDR a Major Theme at EU MedTech Forum 2022 

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. 

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June 29, 2021

[FEATURED] How To Navigate MDR, Brexit And COVID-19 Candidate-Driven Medtech Recruitment Market

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.

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June 22, 2021

[FEATURED] Sprinting To Approval: Insider Tips On FDA’s Breakthrough Devices Program

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.

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May 25, 2021

[FEATURED] Open The Champagne! EU Go Ahead For Standards Needed For New Medtech Regulations

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.

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July 27, 2020

The European Commission Pledges Make the Different Eudamed Modules Available On A Rolling Basis

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: 

  • Registration system 
  • Collaborative system 
  • Notification system 
  • Dissemination system (open to the public) 
  • Interoperable 

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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