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European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU Notified bodies urging to submit Class D legacy devices’ application sooner

As the transitional deadlines for IVD devices are fast approaching, the Notified Bodies have communicated with MedTech Europe to encourage manufacturers to submit their applications for compliance with the IVD Regulation as early as possible. Manufacturers are urged to submit applications for Class D legacy devices before end-2023, in order to meet the deadline of 26 May 2025.
Ashleigh
May 12, 2023
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UK Medtech and Diagnostics Strategy

The DHSC Medtech Directorate shared the final details of the strategy which has been submitted to ministers this week, it has not substantially changed from the initial presentations and information that members were provided at our AGM in March 2022. The approval and response from ministers are expected this week, to aim to publish on the 4 July, however there…
Natalie Creaney
June 24, 2022
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June MedTech Trade Association Forum meeting

The agenda covered various updates across Government, lead by the Department of Health and Social Care. The new Northern Ireland Bill was discussed, and what this could mean for products between Northern Ireland and Great Britain. The Bill still needs to pass though parliament before it enters into force, but it could introduce a dual regulatory route for products allowing…
Natalie Creaney
June 24, 2022
Membership NewsMembership News Archive

BIVDA attend Parliamentary Reception in support of innovation in MedTech

BIVDA attended the MedTech Innovation Parliamentary Reception on the evening of 25 May. Parliament’s Churchill Room was filled with illuminating chatter throughout the evening as organisations, experts and policymakers all sought to learn more about exciting developments in the MedTech sphere and how innovation can be supported. Among many others, we were delighted to see Baroness Masham of Ilton, Chris…
Natalie Creaney
May 27, 2022
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New MedTech Strategy in development

The Department of Health and Social Care is working on a new MedTech Strategy. The Diagnostics Strategy was presented to members at the Annual General Meeting in March, and the Medtech Strategy to the MedTech Trade Association forum in April. The aim of these strategies is to ensure the healthcare system has access to safe, effective, innovative and ground-breaking medical…
Ben Kemp
April 14, 2022
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New 2022/23 Policy document published for the MedTech Funding Mandate

NHS England has published its ‘MedTech Funding Mandate policy 2022/23: guidance for NHS commissioners and providers of NHS-funded care’. This policy aims to direct the NHS on which MedTech innovations are effective and likely to give savings on investment; and to ensure the NHS has a sustainable approach to overcoming the financial barriers to adopting medical devices, diagnostics and digital…
Ben Kemp
March 11, 2022
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