Regulatory Strategies for OTC Switch Programs, Implementing EU MDR & IVDR and a Preview of January

Posted 22 December 2017 By Gloria Hall

placeholder+image Feature articles over the past several weeks provided background, approaches, regulatory considerations, and strategies for implementing prescription to Over-the-Counter (Rx-to-OTC) switch programs; CE marking requirements of IVD medical devices under the new EU regulation; explanation of Annex I general requirements and essential requirements; implementation strategies for the new EU medical devices regulations; and medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes in India.

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Categories: Prescription drugs, Over the counter drugs, In vitro diagnostics, Medical Devices, Clinical, Features, US, Europe, India

Tags: Feature Editorial

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