Risk Management for Drug-Device Combinations



I have a question regarding the European MDD requirements for drug-device combination products - specifically a pre-filled syringe.
I know that this type of combination product is approved via the EU medicinal legislation, in conjunction with satisfying the ERs of the MDD for the device element.

My question is specifically in relation to how to manage post-market risk management/post market surveillance in accordance with ISO 14971 and ISO 13485 for the device part.

In the post market phase, the drug-device combination will be subject to the medicinal pharmacovigilance requirements.
Does the medical device vigilance requirements apply to the device element?

Can anyone tell me how they manage the device post market surveillance requirements & post-production monitoring risk management processes for this type of product?

In practical terms, do you end up with a parallell post market process for the device portion and the medicinal/combination portion of the product?

Any advice or practical help would be very much appreciated!


Even though this is an old post and the last request to answer is already six months old, I will try to explain.

First of all, there are two things which need to be differentiated:

1. Risk Management requirement
2. Vigilance requirements

Concerning the vigilance, I have to say that there is no requirement in Europe to report Incidents related to such a single-entity product (e.g., pre-filled syringe) under Device reporting. As such a pre-filled syringe is approved under the medicinal product directive, any issues need to be reported under drug reporting.

Actually in Japan (since November 2016) and in the US (as of Mid of 2018) it is different. In those countries, you have to decide if a reportable case is caused by the drug or device part and then you have to report either under device or drug reporting or even both reporting pathways.

When it comes to Risk Management for a single-entity in Europe, as the question author already said, there is the requirement to comply with the Essential Requirements. This means you have to consider Risk Management for the device, respectively the combination product. Therefore you have to set up and maintain a risk management file. :bigwave:
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