Drug/Device Combinations: New Position Paper Explains Notified Body Responsibilities

 
• By Amanda Maxwell

Medicinal products authorities will consider a medtech notified body opinion on the device element of a drug/device combination product. A new position paper explains how roles and responsibilities are shared between medtech and medicinal product experts.

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The EU’s medtech notified body association, TEAM-NB, has issued a position paper on documentation requirements for drug/device combination products, which also explains the extent of the notified bodies’ remit with products that also fall under medicinal product legislation.

The document focuses on products that fall under the scope of Article 117 of the EU’s Medical Device Regulation (MDR).

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