Correction of the European regulation on quality management for notified bodies of medical devices
10 Jun 2026Effective: 05 May 202652 views
Who is affected:
Notified bodies, manufacturers of medical devices and in vitro diagnostic devices in the EU
Summary
The European regulation establishing quality requirements for bodies certifying medical devices and in vitro diagnostic products is corrected. It affects notified entities that assess the conformity of these products in the EU.
Detailed analysis
PRO
This correction affects the Implementing Regulation (EU) 2026/977, which sets uniform quality management requirements and procedures for conformity assessment activities carried out by notified bodies under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). Notified bodies must comply with harmonized standards to cer…
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OJ:L_202690455: Berichtigung der Durchführungsverordnung (EU) 2026/977 der Kommission vom 4. Mai 2026 zur Festlegung bestimmter einheitlicher Anforderungen an das Qualitätsmanagement und die Verfahren für die Konformitätsbewertungstätigkeiten, die von einer Benannten Stelle durchgeführt werden, welche gemäß den Verordnungen (EU) 2017/745 und (EU) 2017/746 des Europäischen Parlaments und des Rates benannt wurde (ABl. L, 2026/977, 5.5.2026)
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