Medical devices, point-of care-testing and biosensors: healthcare industry insights from the Council of the European Union
Alessio Cortelazzo
Clinical Trial Manager | Director Diagnostic | Associate Professor in Clinical Biochemistry and Clinical Molecular Biology
Market is estimated to grow on average at a 10% beetween 2023 and 2033 towards a personalized medicine and a decentralized healthcare system
Today, 07 March 2023, the Council of the European Union adopted a regulation which extends the deadline for the certification of medical devices. This measure aims to prevent that medical devices which cannot be certified by the initial cut-off date become unavailable for European patients.
Only devices that are safe and for which manufacturers have already started the certification procedure will benefit from the additional time.
This revised timeline will provide more flexibility to industry for the ongoing certification of needed medical devices and reduce short-term risks of shortages.
The Medical Devices Regulation has been applicable since 26 May 2021. It provides for a transition period until 26 May 2024. The transition to the new Regulation has been slower than anticipated and healthcare systems in the EU are facing a risk of shortages.
Producers of medical devices will now have until December 31, 2027, for higher risk devices and until December 31, 2028, for medium and lower risk devices to meet the legal requirements.
Despite considerable progress with the implementation, the transition to the new rules has been slower than anticipated.
Today, healthcare systems throughout the EU are facing a risk of shortages of life-saving medical devices for patients.
Additional efforts are needed to address:
The Commission is supporting the transition to enhance:
Associate Professor of Analytical Chemistry at Dept. Pharmacy, University of Naples "Federico II"uninanobiosensors.com
1 年Thank you for sharing these info