Official MDR & IVDR Corrigendum published!

On May 3rd 2019, the Corrigendum of both Regulations was published in the Official Journal of the European Union.

Apart from some minor grammar changes, the most significant changes to the original text of the MDR concern Article 10(15) (Obligations of the manufacturers), Article 74 + Annex XV Chapter II, Section 2.5 (Clinical investigations), Article 120(10) (Transitional provisions), Annex VII Section 4.5.2 (Quality management system auditing), Annex VIII Section 3.2. (Classification of accessories), Annex IX Section 2.3, Section 3., Section 3.5.(Quality management system assessment), Annex IX, Section 4.3 (Notified body assessment of technical documentation).

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