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MedTech Europe Updates Regulatory Affairs Newsletter

MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New MedTech Europe leaflet – Four urgent targeted measures – MDR/IVDR implementation

As part of MTE's advocacy efforts on the Future of Regulatory System they are pleased to share the new leaflet outlining four key urgent targeted measures. Our sector calls for these key targeted measures to support the implementation of the MDR & IVDR. They should kick-in urgently and ahead of the anticipated legal reform in 2026. The four targeted measures…
Ben Kemp
May 9, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Joint MedTech Europe/COCIR Reflection Paper on MDSAP

MedTech Europe and COCIR have jointly published their position paper asking for the UE to join as a full member of MDSAP (Medical Device Single Audit Program). This aligns with our own position that the UK should also join, and make MDSAP optional alongside the current ISO 13485 Certification program regarding Quality Management Systems certification. You can read it here.
Ben Kemp
February 21, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Publication of the MedTech Europe 2024 Regulatory Survey Report

MTE are pleased to announce the publication of the MedTech Europe 2024 Regulatory Survey Report and Executive Summary. This comprehensive report provides valuable insights into the current regulatory challenges faced by manufacturers under the In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR). The findings highlight key concerns such as increased costs, regulatory unpredictability, and delays in conformity assessments,…
Ben Kemp
January 24, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

IVDR/MDR implementation – EU Commission (GÖG) Survey – Please participate (Deadline 28/02/2025)

The European Commission continues to gather evidence of the impact of IVDR implementation, especially on manufactures plans to transition devices from IVD directive to IVD Regulation, or more importantly which devices manufacturers do not intend to transition. UK manufactures or subsidiaries who place product on the EU market including Northern Ireland are strongly encouraged to respond, noting that group companies…
Ben Kemp
January 8, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Follow-up: MedTech Europe quarterly webinar for Partner Trade Associations

Dear Members, please see below link to the MedTech Europe Quarterly update. There is a significant focus on the review of the IVDR/MDR implementation. Following the MedTech Europe Quarterly Webinar held on 16 December 2024, please find below the link to watch the 30 minutes presentation held by our speakers, as well as the slide deck used during the meeting…
Ben Kemp
December 19, 2024
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MedTech Europe quarterly webinar for Partner Trade Associations around the World (Mon, 16 Dec 2024 3-4 pm CET)

On Monday, 16 December 2024 at 15:00 – 16:00 pm CET (Brussels time), MedTech Europe will host its next quarterly webinar regarding the implementation status of the EU in vitro Diagnostic Medical Devices and Medical Devices Regulations (IVDR and MDR) for its partner medtech trade associations around the world. The webinar will be 60 minutes in duration including a 30-minute…
Ben Kemp
December 5, 2024
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For information: F-Gas exemptions published in EU OJ

Dear members, please review the MedTech Europe update below on the Exemptions covered by the F-Gas regulation. Please send me any feedback. This legislation will impact CE marked goods including those placed on the NI market.   Dear members, I hope you are all well. We would like to inform you that the Commission exemptions for certain F-Gas uses (Annex…
Ben Kemp
November 1, 2024
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Updates on EP resolution and MedTech Europe’s reaction

Dear members, be advised that the European Parliament voted through the attached resolution in regard to the focused evaluation of the implementation of the EU IVDR/MDR. Please find here MedTech Europe's feedback and response. There have been significant conflicting calls for the European Commission to both speed up the review, as the problems are now, but also calls not to…
Ben Kemp
November 1, 2024
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Class D – press release Notified Bodies

To: Class D WG and Regulatory Affairs IVD Committee Dear members, Regarding Class D devices under EURLs, please note to the recent press release from the TEAM-NB (Notified Bodies’ association) accessible via the following link. The press release confirms Notified Bodies’ positive reception of the newly revised MDCG 2021-4 guidance and provides reassurance that the batch testing process will continue…
Ben Kemp
October 9, 2024
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