Module 18 2021

07/02/2021

HOW TO MANAGE THIS FOR..

DRUG DEVICE COMBINATIONS?

The Organisation for Professionals in Regulatory Affairs

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Drug device combination products

Minimal requirements: Medicinal Products Directive 2001/83/EEC as amended , Annex I (3.2) 12. Where applicable and if needed, a CE marking which is required by Community legislation on medical devices shall be provided.

The Organisation for Professionals in Regulatory Affairs

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