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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

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

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

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

Animal testing roadmap consultation

Members are kindly invited to inform MedTech Europe if they should engage in the consultation, and if yes, share in the document at the link here, answers to the following questions: What are members’ views on the proposed actions for the future roadmap summarized above? Is there something missing? Is there support members require to gradually phase-out animal testing? E.g. research,…
Ben Kemp
September 24, 2024
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Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860

Dear Members, MedTech Europe have drafted a manufacturers declaration to Regulation (EU) 2024/1860, the latest IVD regulation transitional legislation. The declaration can be used to support the continued use of IVD Directive Certificates that have expired, but where the manufacturer continues to meet the requirements of the updated legislation and Article 110 of the IVD Regulation 2017/746. To: Regulatory Affairs…
Ben Kemp
September 11, 2024
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Feedback on EU RoHS exemption pack utilisation

BIVDA and MedTech Europe are gathering information on the EU RoHS (including Northern Ireland), exemption pack renewal for Lead and Mercury in product type 8 – medical devices include those specifically for IVDs. If you rely on the exemption packs for RoHS compliance to place products on the EU and/or Northern Ireland markets, then please let BIVDA know. MedTech Europe…
Ben Kemp
September 3, 2024
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For information: RoHS Umbrella Project letter Packs 22-24

Dear Members, please see below the notification from MedTech Europe regarding EU RoHS (but also impacting UK RoHS, as these assessments were kicked off prior to BREXIT). The Umbrella Project coordinates and submits applications for RoHS exemption packs when there is a more general and not specific sectorial exemptions. The main issues are: need for clarification of whether new applications…
Ben Kemp
July 16, 2024
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MedTech Europe survey on eIFUs for IVDs (deadline: 17 May 2024)

MedTech Europe are conducting a survey for Europe based users of Near-Patient Testing devices (e.g. Medical Doctors, Physicians, Nursing staff, Operators, Pharmacy staff, Emergency Room staff, Ambulance staff) on the subject of electronic instructions for use (IFU) for Near-Patient Testing devices. This survey will provide invaluable insights into the practice in the healthcare field in the EU. Why are MedTech…
admin
April 24, 2024
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

BioMedical Alliance publishes a statement on shortage of diagnostic tests

The European BioMedical Alliance (36 leading European medical societies that together include more than 400,000 researchers and health professionals) along with the European Federation of Clinical Chemistry & Laboratory Medicine (EFLM) have published a Statement: “Urgent action needed to prevent widespread shortage of diagnostic tests”. This document points to the persisting problems with the implementation of EU IVDR. It calls…
admin
January 24, 2024
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