The device is right

The distinction between the pharma and medical device industries is blurring. For some therapies, delivery of the drug can be crucial to ensure reliable patient outcomes. To support the current trend of more home care and patient self-administration, drug delivery devices have become more complex, often relying on software apps to support the patient and/or provide input to the health care professional.

In Europe, the medical device part of a drug device combination (DDC) was in the past assessed by the EMA as part of the Marketing Authorization Application (MAA). But with medical devices becoming increasingly complex, the European Commission added the (in)famous article 117 to the EU Medical Devices Regulation (EU) 2017/745 (EU MDR). Article 117 requires a notified body to evaluate the safety and performance of the device part of a DDC; notified bodies are organizations that have been designated by the competent authorities of the EU member states and the EU Commission to verify the safety and performance of medical devices. In short, an extra approval step is required for a DDC in Europe.

For the device part of a DDC, unless it is a class l device, a notified body needs to evaluate the compliance of the device to the relevant sections of Annex l of the EU MDR – either as part of the CE marking of the device or by obtaining a “notified body opinion.”

Unsurprisingly, it is the “how” that makes the process more complicated, as highlighted in the guidance document from EMA. There are three pathways that a pharma company can apply – each with pros and cons.

Read the full Medicine Maker article