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Risk Management for Drug-Device Combinations
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Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
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Risk Management for Drug-Device Combinations


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ce mark and ce marking, combination devices and related rules, combination drug-device products, post market surveillance, risk management and analysis
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  Post Number #1  
Old 20th April 2015, 08:14 AM
Dollymixture

 
 
Total Posts: 3
Please Help! 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!

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  Post Number #2  
Old 12th August 2017, 06:19 AM
Marc's Avatar
Marc

 
 
Total Posts: 26,038
re: Risk Management for Drug-Device Combinations

This is an old one to Bump, but my Thanks in advance to anyone who can add an answer.
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