En esta MDCG 2020-10/1 Rev.1 se incluyen los siguientes cambios:
Section 3 new definitions
Section 4, intro clarification on filling in the reporting table
Section 5, table updated
Section 5.1 clarification on reporting duties
Section 5.2.2 internal reference
Section 9.4 clarification
Section 10.2.1 coding
Sections 10.2.15-17 new
Section 10.2.19-20 clarification
MDCG: Revisión 1 de la MDCG 2020-10 «Guidance on safety reporting in clinical investigations under the MDR»
