EU Plenary Debates How To Protect Orphan Devices From MDR Crisis
Steps are being taken in the EU to address shortages of critical medical devices as a result of regulatory pressures, including those for use in children and for rare conditions, the European Commission’s Stella Kyriakides stated during a recent debate.
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EU Council Adopts MDR/IVDR Amendment Proposal
The EU Council has adopted proposed changes to the EU Medical Device Regulation that will see transition deadlines extended for legacy devices. This completed final legislative step means that the amendments are set to enter force in around a week’s time, on 15 March.
International Initiative Tackles Paucity Of Rare Disease Devices
What is the importance of medtech in diagnosing and treating rare diseases? This is among the key questions that an international working group aims to address through a collection of articles in the Orphanet Journal of Rare Diseases.
More Than 50% Of EU Clinicians Report Recent Medical Device Shortages
Shortages of medical devices ranging from insulin pumps to robotic surgical systems are impacting clinicians across the EU, leaving many healthcare providers without effective alternative products, a report by the Biomedical Alliance in Europe shows.