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Staying on Top of MDR, IVDR, and Surveillance Requirements With Cloud QMS

Arena Solutions

JUNE 29, 2023

As a result, the European Union Medical Device Regulation (EU MDR) and In vitro Diagnostic Device Regulation (EU IVDR) were approved in March 2017 by the European Council and in April 2017 by the European Parliament. May 26, 2026: Class C self-declared IVDD devices must comply with the IVDR.

Resource Reduction 76
Resource Reduction Europe Manufacturing Quality 76
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How to Classify Your Medical Device Under the EU MDR and IVDR

Arena Solutions

AUGUST 7, 2023

no notified body involvement) under the IVDD as follows: • Class D devices: May 26, 2026 • Class C devices: May 26, 2027 • Class B and Class A sterile devices: May 26, 2028 STEPS FOR CLASSIFYING YOUR MEDICAL DEVICE UNDER THE EUROPEAN REGULATIONS 1. MDCG 2021-24 Guidance on Classification of Medical Devices MDCG 2020-16 rev.

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How To Quality Manufacturing Procurement Examples 77
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