Drug-device combination (DDCs) products are therapeutic and diagnostic products that combine medical tool with tablets, and/or biological products. on account that these are claimed to obtain drug concentrated on, it's far taken into consideration as more secure and more powerful treatments for local management and individualized therapy. Such technologies are termed as boon for sufferers laid low with critical illnesses and situations such as most cancers, heart disease, more than one sclerosis and diabetes, amongst others.  

Ex. Pre-filled syringe, Pen injector, Auto injector, Metered dose inhaler, Drug eluting stents, Catheter with antimicrobial coating, etc.

Drug-device mixture merchandise have also emerged as a brand new dynamic in medical product development, regulatory approval and company interplay worrying enhancements in communications and coordination. development of latest mixture merchandise and assuring its timely and correct marketplace access involves defined sample of interactions among manufacturers and regulatory corporations.

Operon strategist is best medical devices regulatory consultancy. we closely working with different regulatory agencies for more than a decade. We are CE mark medical device certification consultant; we know how to classify the product and make dossier as per classification which makes error-free certification process. To avail our services do contact us or whatsapp us your requirement.

CE drug-device combination

FDA has virtually described drug –device mixture products in 21 CFR 3.2(e) while eu do no longer have a single definition in their criminal framework.eu has regulated combination products both as medicinal products or clinical gadgets. For Medicinal product part in combination tool, assessment is carried out by ecu drugs enterprise (EMA) whereas Notified bodies do assessment for the tool element. Notified bodies are the agency distinctive with the aid of the ecu commission to evaluate the conformity of clinical devices before being located available on the market. 

In response to multiple requests for advice on mixture tool first-class necessities, EMA posted “Draft suggestions on excellent requirements for clinical gadgets in combination products” which addressed the new duties in regulation (eu) 2017/745 on medical devices, in particular the requirements below Article 117. this article foresees that the advertising authorisation utility need to encompass a CE (Conformité Européenne) certificates or announcement of conformity for the device or, in sure instances, an opinion from a notified body (NB) at the conformity of the device.

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