The commission is in talks with EU member states to identify possible regulatory bottlenecks in the approval of combined clinical trials for a medicinal product and a clinical performance study of an IVD.
The European Commission is taking steps to ensure that ongoing challenges posed by the implementation of the In Vitro Diagnostic Regulation (IVDR) does not cause unintentional delays to drug clinical trials that are to be run in combination with IVD studies.
Concerns on this front were highlighted in a recent survey by the European industry federation for research-based drug companies, EFPIA....
Create an account to read this article
Already a subscriber?
MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.
The European Commission is focusing on how tiny particles behave to help create an EU industrial “powerhouse.”
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
