Module 17 2024

03/12/2024

EU MDR & advertising – Article 7 prohibition of misleading claims

Bites on activity as well as materials

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• Off-label promotion

• Positive representations

• Omissions / failure to warn

• Importance of aligning with CE marked intended purpose

The Organisation for Professionals in Regulatory Affairs

TOPRA MSc Module 17

19

EU MDR & advertising – Article 32 Summary of Safety & Clinical Performance

• Alignment of advertising materials and promotional claims / statements • Periodic reviews and ad hoc reviews to maintain alignment

Implantables & Class IIIs

•

‘Living document’

•

Content must include:

•

• the intended purpose of the device and any indications, contraindications and target populations

• possible diagnostic or therapeutic alternatives

• summary of clinical evaluation and relevant information on post-market clinical follow-up

• suggested profile and training for users

• information on any residual risks and any undesirable effects, warnings and precautions

The Organisation for Professionals in Regulatory Affairs

TOPRA MSc Module 17

20

10