With the 2017 Medical Devices Regulation (MDR) fully operational from May 26, 2021, Article 117 has brought significant changes. It now requires that the device portion of integral drug-device combination products must have an evaluation from a Notified Body to ensure compliance.

In July 2021, the European Medicines Agency (EMA) offered detailed guidance on the quality documentation needed when medicinal products are used with a medical device. This guidance covers:

• Integral drug-device combinations
• Co-packaged drugs and devices
• Drugs with referenced devices

It emphasizes the importance of devices in clinical trials meeting the General Safety and Performance Requirements (GSPR), particularly to reduce the need for bridging data at the time of marketing authorization.

Compliance Challenges for Drug-Device Combination Products with Article 117

The challenges for pharmaceutical and biotech companies to comply with the new requirement stem from the fact that many drug manufacturers usually do not have the systems in place to put together technical information related to their devices to show compliance with the General Safety and Performance Requirements (GSPR).  

This technical information is needed to obtain an opinion from a Notified Body. In addition, Device suppliers are sometimes not willing or not able to supply the necessary information. Some of the challenges faced by drug manufacturers include: 

• Lack of proper device systems in place to create necessary technical information.
• Difficulty obtaining necessary information from device manufacturers.
• Lack of sufficient knowledge about the General Safety and Performance Requirements (GSPR).
• No experience with interfacing with the Notified Bodies 

How to Stay Compliant with Article 117 for Drug-Device Combinations?  

To stay compliant, pharmaceutical and biotech companies should seek advice early in the development pathway of their drug-device combinations.   

Manufacturers should ensure they have the necessary expertise to collect and compile their technical files describing the device part of their combinations. They should seek advice on how to approach the Notified Bodies and receive a positive opinion from them.  

Especially for complex combinations, manufacturers should make sure that they have all the information needed to comply with Article 117. Since the approval of marketing authorization often depends on a positive opinion from the Notified Body, it is prudent for pharmaceutical and biotech manufacturers to seek such approval.

For complex devices, such as auto-injecting pens, pharmaceutical companies may also receive device parts from non-medical device partners. These parts are then assembled by the pharmaceutical and biotech companies themselves. In this scenario, in-house or outsourced expertise is necessary to stay abreast of new requirements. 

Conclusion

The approval of marketing authorizations can hinge on a positive evaluation from a Notified Body for drug-device combinations. Early and informed preparation is key to demonstrating compliance with Article 117 and the GSPR. Leveraging in-house or external expertise can significantly streamline this process, making it a strategic priority for manufacturers to stay informed and proactive.

QbD Group offers a team of in-house experts ready to assist you with preparing technical documentation, engaging with Notified Bodies, and updating your Common Technical Document (CTD) sections to ensure compliance with Article 117 of the MDR and associated pharmaceutical regulations.

Don’t hesitate to contact us should you need any assistance.