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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.    
admin
March 9, 2023
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…
admin
March 9, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC notice on the Windsor Framework

DHSC have provided the following update for stakeholders: You will have seen the announcement yesterday on the Windsor Framework, which concludes an agreement between the UK and the EU on the Northern Ireland Protocol. This framework includes simplifications to customs and Sanitary and Phytosanitary (SPS) processes that will significantly reduce requirements on traders. We are working through the details of…
admin
March 9, 2023
HighlightsHighlights Archive

Media Monitoring: 22 – 28 October

5 million to be invited to participate in early disease diagnosis scheme Our Future Health is aiming to recruit 3 million people in the UK this autumn to take part in this project to diagnose and treat diseases earlier 5 million will eventually be recruited, with participants sharing their health records and giving blood samples, as well as having their…
admin
October 28, 2022
HighlightsHighlights Archive

Digital reforms in the NHS to be accelerated

Patients are set to benefit from more streamlined care and be able to make more informed choices about how and where they access treatment after plans to transform NHS data sharing were brought forward. The Department for Health and Social Care (DHSC) said the proposed transfer of NHS Digital’s functions into NHS England (NHSE) which were due to happen at…
admin
October 28, 2022
HighlightsHighlights Archive

The Sunak Government: Key Changes for BIVDA

As you will have no doubt noticed, this week saw the arrival of Rishi Sunak as the new Prime Minister. Mr Sunak is now the first British Asian and Hindu UK Prime Minister which, no matter where your political allegiances lie, is a definite cause for celebration in a landmark moment in UK history. Liz Truss’ fleeting stint as Prime…
admin
October 28, 2022
Regulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Regulations: ecodesign of energy-consuming products – Regulatory Affairs Newsletter #1

Guidance for manufacturers, their authorised representatives and importers. Change made: Declaration of Conformity template added. Other pages commonly used European Commission updates MedTech Europe updates HSE eBulletins UKRI updates Home Office updates Office for Life Sciences bulletin Cabinet Office weekly update (extract of original bulletin) Environmental Agency weekly update (extract of original bulletin) MDCG updates Could consider Upcoming regulatory or…
admin
September 28, 2022
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