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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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Exemption of Routine Blood Draws from Article 58.1(a) of the IVDR (MedTech Europe)

Public Technologies 12 Mar 2025
IVDR article 58.1(a) should not be applicable to performance ... The In Vitro Diagnostic Medical Devices Regulation 2017/746 ("IVDR") outlines requirements for performance studies in articles 66-76 ... -Sponsor submit application to IVDR.
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Article 10a MDR and IVDR: Decision guide flowchart (MedTech Europe)

Public Technologies 11 Mar 2025
Article 10a MDR / IVDR ... It is based on the text of Article 10a MDR/IVDR itself, as well as the Q&A document which has been developed by the European Commission in collaboration with stakeholders and was published in December 2024 ... 2 (23) IVDR.
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Article 10a MDR / IVDR: Notification in Case of Interruption or Discontinuation of Supply (COCIR - European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry)

Public Technologies 11 Mar 2025
Article 10a MDR / IVDR ... It is based on the text of Article 10a MDR/IVDR itself, as well as the Q&A document which has been developed by the European Commission in collaboration with stakeholders and was published in December 2024 ... 2 (23) IVDR.
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Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for ...

Business Wire 10 Mar 2025
SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE.
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