The EU is at a crossroads now on health care product innovation, particularly where drugs are used in combination with devices and IVDs. There is a concern that unless some of the regulatory hurdles are better managed, and urgently, that EU industry and patients alike are going to suffer.
Article 117
One of the biggest differences under the MDR compared with the directives is the regulation of an integral drug/device combination which is not reusable and where the drug has the primary action.
Under Article 117 of the new MDR, it is made clear that notified body involvement is needed for European market authorization of a medicinal product incorporating an integral medical device. whereas under the directives, it had simply said that the essential requirements of Annex I of the MDD are applicable to establish the safety and performance of the device.
In such cases the notified body opinion of the device element must be submitted by the manufacturer to the EMA as part of the market authorization application by the manufacturer. It will then be assessed by the competent authority and the final approval is down to the EMA.
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