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Regulatory Affairs Newsletter Archive

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
EMA pilot launched for expert panels on high risk medical devices European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

EMA pilot launched for expert panels on high risk medical devices

For class III implantable devices, class IIb active devices intended to administer or remove medicinal products from the body, and Class D in vitro diagnostic medical devices, the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) require notified bodies to consult expert panels before issuing a CE certificate. EMA is now running a pilot that enables the expert panels to…
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March 9, 2023