Find Your EU Notified Body Now Or Risk A ‘Nasty Surprise’
Companies developing drugs with integral medical devices such as pre-filled syringes in the EU are desperate for guidance on how to comply with a provision that Europe’s new Medical Device Regulation will introduce for them. Speakers at a regulatory conference in Sweden had some important advice for them.
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New EU guidance includes more information for drug-device combination product makers who are worried about how to comply with requirements being introduced for pharmaceuticals under the new EU medical device rules.
Long-awaited draft EU guidance on the quality requirements for integral and non-integral drug-device combination products will be published very soon.