The European Medicines Agency (EMA) have 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. This guideline provides guidance on the documentation expected for Drug-Device Combinations in the quality part of the dossier for a marketing authorisation application or a variation application. In recent years there has been an increase in scientific advice requests where a medicinal product incorporates, either in an integral or non-integral manner, a medical device/medical device component for the use of the medicine. The availability of devices with automated functions is growing significantly and the availability of these devices will benefit patients with regular and long-term dosing requirements. Patients will be able to receive dosing requirements in an outpatient setting either by self-administration or with the support of a professional.
In this guideline the terms ‘integral’ and ‘non-integral’ are used to describe drug device combinations. Integral DDCs refers to devices intended to administer a medicinal product, where they form a single integral product intended exclusively for use in the given combination and which is not reusable. An example of an Integral DCC is Single dose pre-filled syringes, pens and injectors. Non-integral DDCs refers to drug device combinations for which the two or more separate components. Devices in non-integral DDCs are those that are co-packaged and supplied along with the medicinal product, or where the product information refers to a specific device to be used with the medicinal product, but the device is obtained separately. An example of a Non-Integral Injection are needles and filter needles.
The quality guideline covers devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product information of the medicine but obtained separately. It specifies which information about the device needs to be submitted as part of the initial marketing authorisation application and subsequently during the product lifecycle. It also contains a proposed template for the Notified Body (NB) opinion on the conformity of the device to the relevant general safety and performance requirements laid down in Regulation (EU) 2017/745. The EMA will consider comments received during the consultation, with a view to finalising the guideline before the regulation fully applies on the 26th of May 2020.