Article 61(5) of the EU’s Medical Device Regulation gives certain manufacturers an exemption from having to perform clinical investigations by demonstrating equivalence to other companies’ products. But to whom does it apply and who could actually make use of it? Dr. Maria Donawa explains why clarification is urgently needed.
Under the current EU Medical Devices Directive (MDD), many companies could rely on a literature review rather than a clinical investigation to demonstrate compliance with clinical requirements. Although, over the years, the rules have become tighter.
The Medical Device Regulation (MDR), which fully applies on 26 May 2020, is much stricter in requiring clinical investigations for...
2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.
The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.
Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.
