IMPLICATIONS FOR DRUG-DEVICE COMBINATION PRODUCTS

 

The drug -device combination (DDC) products are the therapeutic or diagnostic products that combine drugs, devices or biological products which leads to safe and effective treatments. It helps in targeted drug delivery, localized drug administration and individualized medicine therapy. With the advancement in technology drug-device combination products have developed a unique form of medicinal products that has cardiovascular, neurological, orthopaedic applications. The widely used DDC combination products are autoinjectors, inhalers, antibiotic-loaded bone cements, bioartificial liver devices, pre-filled nebuliser, pre-filled pen, pre-filled syringe, transdermal patch etc. 

EUROPE’S MDR AND CE MARKING  

The European Medicines Agency (EMA), has put forth the guidance for compliance issues for manufacturers of combination products with drug and medical device components. For drug-device combination products to be marketed in the European market it should undergo conformity assessment results or CE mark issued by notified bodies. For the devices that do not have CE marking the manufacturers need to submit conformity regarding components to MDR requirements from the notified bodies. 

Read Article 

• EU MDR checklist – Effects on Medical Devices
• Regulating medical device combination products

IMPLICATION OF MDR ARTICLE 117 FOR DRUG-DEVICE COMBINATION PRODUCTS

The medicinal product and the medical device are combined to form an integral product and are subjected to EU Medical Device Regulation (MDR) 2017/745. The European Commission under the medical device regulation (MDR) has introduced article 117 which states the requirements for manufacturers for placing drug-device combination products into the market. 

Read More - Drug -device combination (DDC) products 

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