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MedTech Europe Updates Regulatory Affairs Newsletter Archive

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Update: culture media and antibodies subject to additional Border Inspection Post controls

Please see below update from Medtech Europe regarding the proposal to include new CN codes in the EU Animal By-products legislation. See also the EC response to the issues posed by MedTech Europe. Please note that these requirements will also impact shipments from GB to Northern Ireland, as well as shipments from third countries to Northern Ireland, and shipments from…
Ben Kemp
June 9, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New educational guide for the use of the European Medical Device Nomenclature (EMDN)

Manufacturers operating under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) are required to utilise the European Medical Device Nomenclature (EMDN) for regulatory submissions, device registration in EUDAMED, and sampling. To support consistent and compliant application, MedTech Europe released a practical guide to the use of the European Medical Device Nomenclature which: Assists in the…
Ben Kemp
May 28, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

IHI Call 11

MedTech Europe are promoting IHI Call 11. Since we rejoined Horizon Europe UK businesses can engage in the EU IHI process. IHI matches academics with industry and matches EU funding with industry funding/resource to work on joint projects to improve health, and tackle problem areas. Just published – Innovative Health Initiative draft topic texts for Call 11 - MedTech Europe
Ben Kemp
May 15, 2025
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
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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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