Module 16 2024

22/10/2024

International Labelling

MDR Annex II.2 requires

● the label or labels on the device and on its packaging…in the languages accepted in the Member States where the device is envisaged to be sold; and ● the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold. ● Professional use exceptions Germany, Norway, Luxembourg ● Often focus is on 5 languages: English, French, German, Italian, Spanish

Differing laws and risks can result in labelling variations

Likely to prove negligence and defectiveness

Does not look good

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Importance of Device Vigilance

Must ensure efficient FSCA/labelling changes

● Vigilance reports disclosable during litigation ● In US, negligence per se to breach FDA reporting requirements ● If inadequate labelling results, company will be liable for resulting injuries

Punitive damages likely if fail to report in U.S.

● Jury assesses damages

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