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NOTICE TO MEMBERS Petition No 1201/2024 by Michael Maier (German) on Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) (European Parliament)

Public Technologies 21 Mar 2025
Petition No 1201/2024 by Michael Maier (German) on Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) ... The petitioner outlines significant challenges in implementing the EU Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR).
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Exploring the Impact of IVDR & MDR – 2024 Survey Findings​ (MedTech Europe)

Public Technologies 20 Mar 2025
) MedTech ON AIR · Exploring the Impact of IVDR and MDR -2024 Survey Findings ... The 2024 Regulatory Survey revealed key challenges that manufacturers face under the In Vitro Diagnostic Regulation (IVDR) ...
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Tekst Publieke Consultatie Gerichte Evaluatie MDR IVDR (The Dutch House of Representatives)

Public Technologies 19 Mar 2025
Bijlage 1 - Tekst Publieke Consultatie- Gerichte Evaluatie MDR-IVDR. The MDR and IVDR were adopted to better ensure patient safety and transparency of the system ... much as possible with the MDR and IVDR.
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MedTech Europe Report on Administrative Burden under IVDR and MDR (MedTech Europe)

Public Technologies 18 Mar 2025
Report on Administrative Burden under IVDR and ... MedTech Europe's Proposal for IVDR/MDR Targeted ... IVDR and MDR. MedTech Europe's Proposal for IVDR/MDR targeted Evaluation ... submission and notification of performance studies under the IVDR.
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Submission of vigilance reports to Notified Bodies under EU MDR & IVDR (MedTech Europe)

Public Technologies 17 Mar 2025
under EU MDR & IVDR ... Submission of Vigilance Reports to Notified Bodies under EU MDR & IVDR ... 1 Further in this document 'MDR/IVDR' is referred to as 'regulations', unless otherwise specified ... (Article 89 and Article 84 IVDR).
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