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European Medicines Agency Seeks Public Opinion on Draft Guideline on Quality Requirements for Medical Devices


European Medicines Agency has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation.

The guideline addresses the new commitment in Regulation (EU) 2017/745 on medical devices, particularly, the necessities under Article 117. This article predicts that the application for marketing authorization of a device should include a declaration of conformity or a CE certificate or in some cases, notified body (NB) opinion on the conformity of the device.

The devices that are essential for the use, administration or dosage of the medicine are included under this guideline. These devices can be integral, co-packaged or referred to in the product information of the medicine but obtained separately. For initial marketing authorization application and subsequently during the product lifecycle, this guideline specifies about the information of a device that needs to be submitted. The guideline has a proposed template for the opinion of the NB on the conformity of the device to the relevant general safety and performance requirements laid down in Regulation (EU) 2017/745.

It is anticipated that this guideline will augment the transparency and constancy of information in regulatory submissions, thereby decreasing work for all stakeholders and eventually improving patient safety.