Module 5 Presentations

16/07/2024

MDCG 2021-05 R1 July 2024

State of the Art (SotA) • 5 definitions • 6 Court Rulings

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the mere compliance with the most recent version of a standard the reference of which has not been published in the OJEU does not automatically imply compliance with the requirements of the applicable EU legislation

• Common Specifications

the use of standards is and remains voluntary (with exceptions), it is not possible to impose the use of a specific standard …

The Organisation for Professionals in Regulatory Affairs

13

When do I need a Clinical Investigation? [MDR Art 62] [MDCG Guidance]

2024-10 "Orphan" Products

needed to show device achieves intended performance

needed to show clinical benefits achieved

2023-7 III imp. exemptions

2020-6 legacy evidence

needed to show safety and benefits > risks

MDR Art 82 “Art 62 Lite” other reasons

2020-5 device equivalence

“On label” use of CE-marked device

The Organisation for Professionals in Regulatory Affairs

14