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Medical devices – extended acceptance of CE marked medical devices on the Great Britain market

Subject to Parliamentary approval this will mean that CE marked medical devices will be accepted on the Great Britain market beyond the current deadline of 30 June 2023.
This will support the ongoing, safe supply of medical devices to Great Britain and is designed to ease the transition to a future strengthened regulatory framework for medical devices.
The government will ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients.


The VASCOVID project focused on optical monitoring of microvascular health in the intensive care and beyond

WEBINAR RECORDING | Regulatory tips for Medical Device and IVD developers

Article 86 MDR requires manufacturers of Class IIa, Class IIb, and Class III devices to prepare a Periodic Safety Update Report (PSUR) for each device and, when relevant, for each category or group of devices. The MDCG 2022-21 guideline endorsed by the Medical Device Coordination Group (MDCG) provides ideas for manufacturers on how to prepare the PSUR for their Medical Devices.


BHH | Meet the members interview

BHH (Barcelona Health Hub) promotes innovation in digital health and its transfer to the sector, linking startups, health organizations, corporations and investors.

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