Module 15 2022

5/19/2022

MEDDEV 2.7.1 Rev 3 (2009)  Rev 4 (2016)

“MEDDEV 2.7.1 rev 4 does not contain new criteria, but represent further explanations of the those introduced by Directive 2007/47/EC. These criteria were already explained in MEDDEV 2.7.1 rev 3 which has been published seven years ago.”

MEDDEV 2.7.1 Rev 3

MEDDEV 2.7.1 Rev 4

29

© NAMSA 2021

29

MEDDEV 2.7.1 Rev 4 (2016)  MDR

MDCG 2020-13 (CEAR Template)

MDCG 2020-6 (legacy devices)

MDCG 2020-5 (equivalence)

MDCG 2020-1 (software)

MEDDEV 2.7.1 Rev 4

MDR (Annex XIV)

MDR (Article 61)

MEDDEV 2.7.1 Rev 4

May 2022

30

© NAMSA 2021

30

15