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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 Archive

EU MDR/EU IVDR amendment approved by EU Council

On 7 March, the European Council unanimously approved the amendment to the EU MDR and EU IVDR. This amends the transitional provisions for the MDR and removes the sell-off provision for IVDs. This is expected to be published in the Official Journal of the European Union this month, which will be when it comes into force. MedTech Europe's press release…
admin
March 9, 2023
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
Membership NewsMembership News Archive

MedTech Europe Sustainability and Environment employment opportunities

MedTech Europe are recruiting a Sustainability and Environment Director and have secondment opportunities in the Sustainability & Environment area. Please see the postings below:   Open Recruitment: New ‘Sustainability and Environment’ Director Position   In light of the ever-growing importance of Sustainability to our industry, we are seeking a Director to lead our work in this domain going forward. This…
Ben Kemp
January 27, 2023
Membership NewsMembership News Archive

Doris-Ann features on a The King’s Fund event panel and attends NAM meetings in Brussels

The King’s Fund held a conference ‘Meeting Demand: the changing picture of diagnostics’ on 16 November. There was a breakfast session before the official opening plenary focussed on Antimicrobial Resistance which was timely as it was just in advance of World Antimicrobial Resistance Awareness Week. The panel discussed how access to diagnostics in primary care needs to be improved as…
Ben Kemp
December 2, 2022
Membership NewsMembership News Archive

MedTech Europe calls for action on energy crisis to reinforce healthcare capabilities

MedTech Europe have outlined the danger that the energy crisis poses the European healthcare sector alongside a call for action to EU and Member States in their paper Europe's Energy Crisis: Actions Needed to Reinforce Healthcare Capabilities. They claim that rocketing energy prices combined with foreseen energy supply disruptions across Member States, are severely impacting the production, assembly, delivery, and…
Natalie Creaney
September 30, 2022
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