The latest insights into work conducted to support the implementation of the IVDR show that much has been achieved already. Ongoing projects remain, however, including those that are continuous. 2024 promises to be a busy year.
The Medical Device Coordination Group (MDCG) has updated its Joint Implementation and Preparedness Plan for the IVDR, highlighting its priority projects for 2024.
Some two-thirds of the nearly 50 projects set out in the original document in 2021 are now marked as complete,...
Create an account to read this article
Already a subscriber?
Berlin medtech associations add to European voice requesting that the EU eases MDR/IVDR and other compliance costs on SMEs.
Urgent action is needed to address gaps in how risks from medical devices and diagnostics utilizing AI are identified, mitigated and managed. So says James Pink, renowned medtech regulatory expert in an interview with Medtech Insight.
Germany’s electronic patient record – ePA – is a flagship initiative of the ongoing national healthcare reform. The medtech industry welcomes rollout of the ePA while calling for further improvements.
EirMed CEO Richard Houlihan warns that EUDAMED (the European database on medical devices) publication delays may harm medical device manufacturers. Currently, only a fraction of the required uploads have occurred, creating potential compliance risks as the mandatory deadline approaches.
The US FDA has published a list of recommendations for the safe use of hyperbaric oxygen therapy devices. While the therapy can be effective in treating several conditions, the agency says providers need to understand its potential risks.
Germany’s electronic patient record – ePA – is a flagship initiative of the ongoing national healthcare reform. The medtech industry welcomes rollout of the ePA while calling for further improvements.
EirMed CEO Richard Houlihan warns that EUDAMED (the European database on medical devices) publication delays may harm medical device manufacturers. Currently, only a fraction of the required uploads have occurred, creating potential compliance risks as the mandatory deadline approaches.
