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Regulatory Affairs Newsletter Archive

MHRA weekly update (20 Feb) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (20 Feb)

Please note this is an extract of the original bulletin. Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU Page summary: The EU Commission has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates Change made: First…
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March 9, 2023
DHSC weekly update (WC 20 Feb) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 20 Feb)

Please note this is an extract of the original bulletin. Plans to bolster patient safety and boost support for frontline staff by streamlining the system for healthcare regulators Page summary: The government will streamline the system to modernise regulatory legislation to boost patient safety and support staff Change made: First published.   Lord O’Shaughnessy to lead independent review into UK…
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March 9, 2023
DHSC MedTech Directorate holding webinar on the Medical Technology Strategy UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

DHSC MedTech Directorate holding webinar on the Medical Technology Strategy

DHSC have provided the following update for stakeholders: The DHSC Medical Technologies Directorate is hosting a webinar on Monday 6 March 2023 at 11:00 – 12:00 to promote the newly published Medical Technology Strategy which was shared with you on 3 February 2023 (https://www.gov.uk/government/publications/medical-technology-strategy). The Government’s inaugural Medical Technology Strategy sets out how we will ensure the health and social…
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March 9, 2023
Team-NB position paper published: guidance for submission of technical documentation European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

Team-NB position paper published: guidance for submission of technical documentation

Team-NB have published the position paper Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Device Regulation (EU) 2017/746. This is listed as "Team-NB PositionPaper BPG-IVDR V1" on the Team-NB website. Please note that although this is a guidance document published by a collective group of Notified Bodies, it is…
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March 9, 2023
MedTech Europe survey results: Transition to the IVD Regulation MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe survey results: Transition to the IVD Regulation

MedTech Europe have published their Survey Report Transition to the IVD Regulation - MedTech Europe Survey Results for October 2022. This report can be found on the MedTech Europe website. The results demonstrate that there are still bottlenecks occurring throughout the IVDR implementation, and indicates where additional attention is needed.    
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March 9, 2023