May 2020 deadline for the EU MDR is fast approaching and the industry is scrambling to find the right resources and understand the application of the regulation to their products.
Unlike the FDA, the EU does not have clear directions on the regulations for combination products. As part of the series of guidance documents that the European Medicines Agency (EMA) released related to the EU MDR, they released a draft guidance document that focuses on drug-device combinations (DDCs). The guidance was released in Q&A format to be able to answer the most common questions faced by the industry.
So, what does the regulatory framework for Drug-Device Combination look like?
The guidance document says that if the action of the medicinal substance is ancillary to the device, in other words, if it’s a device led combination product, then the medical device must bear a CE mark and a scientific opinion must be obtained from the medicines authority for the medicinal substance before the notified body can issue the conformity certificate.1
If the action of the medicinal substance is principal, in other words, if the product is a drug led combination product, then the product is regulated under the medicinal product’s framework and in that case, the General Safety and Performance requirements of the EU MDR apply to the device. Read our blog: EU MDR ANNEX I SIMPLIFIED to know more about the general safety and performance requirements.1
For devices that are intended for administration purposes:
If the administration device is a single integrated product, can be used exclusively in the given combination and cannot be reused, the combination product is regulated under the medicinal product’s framework, and the GSPR of the EU MDR applies to the device. In all other cases, the administration device is regulated under the EU MDR and must bear a CE mark.1
Confused about how EU MDR applies to your combination product? Call us today at 248-987-4497 or email us at email@example.com.
1European Medicines Agency (Oct 2019) Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) retrieved on 03/04/2020 from https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf