European Medicines Agency issued a new draft guidance related to drug-device combinations. This particular regulation specifies the necessary documents for the application for marketing authorization for these types of devices.
This particular regulation specifies the required documents when applying for the marketing authorization of these device types.
The Scope of the Regulation
For the purpose of the guidance, a medical device falls under the drug-device combination (DDC) category if they are:
- an integral part of the medical product,
- co-packaged with the medicinal product,
- referenced in the information on medicinal product.
All DDCs could be divided into integral and non-integral parts, since it is important from a regulatory point of view.
It is necessary to prove the conformity of an integral combination.
However, non-integral DDC only need to be CE marked.
Integral devices fall within the scope of MDR and Regulation EU 2017/745
Devices of this type could have measuring, delivery or metering functions.
The most common example of the DDC is a special dozer, an insulin dossier intended for patients with diabetes. These type of devices are intended to automatize dozing of medicinal product.
Non-integral devices could exist separately from medicinal product and include various caps, delivery pumps and many other reusable device parts.
Also in several cases, the aforementioned devices should be regulated by other applicable legislation since the present guidance is not exhaustive.
Main Points of the Guidance
The new guidance also includes information on data submission, updated template for the opinion of the regulatory authority on the conformity of the device, in accordance with applicable rules and regulations.
According to the guidance, the device should be evaluated both separately and together with the appropriate medicinal product.
Marketing authorization application should include:
- Structured information on safety, quality and efficiency of the product,
- Reference to similar (already approved) products as supportive additional information,
- Information on manufacturing and control methods.
The construction of the device should provide safety and protect the contained medicinal product, if applicable.
Other requirements specify that the name of the device should be in accordance with applicable terminology.
Information provided should also cover such issues as storage conditions, preparation or handling instructions, and list of materials used.
The outer packaging should contain all appropriate marking as well.
CE marking for medical devices should be placed only on the device itself.
Most importantly, the information provided should also cover all relevant issues including information on drugs used together with the DDC.
The upcoming changes aims to increase the transparency of the marketing authorization process.
The changes will also attempt to simplify the related procedures, which will lead to general improvement of the safety.
It is important to note that this version of the rules is not final; the regulating authority will accept comments and proposals during a public consultation period, which will last three month.
The guidance should be applied together with the Medical Products Directive 2001/83/EC and Medical Devices Regulation (EU) 2017/745 to cover the full scope of the related issues.