What Combination (Combined Advanced Therapy Product) Products are Approved in the EU?

F

Fifi2006

#1
Hi,

I am trying to figure out what Combination Products are approved in the EU.

The definition for Combination products in the EU is a "combined advanced therapy product’ is defined as one that incorporates as an integral part one or more medical devices, or active implantable medical devices, and viable cells or tissues, or non-viable cells or tissues where the action on the human body of these cells or tissues is primary to the device." e.g. a drug eluting stent.

I have found the examples of combination products approved by the FDA for the U.S. market in this site: Examples of Combination Product Approvals

But I cannot find the European equivalent site.

Can anyone help me with this, please?

Cheers, F.
 
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Stijloor

Staff member
Super Moderator
#2
Re: What Combination (Combined Advanced Therapy Product) Products are Approved in the

Can someone help?

Thank you!

Stijloor.
 

bio_subbu

Super Moderator
#3
Re: What Combination (Combined Advanced Therapy Product) Products are Approved in the

Hi,

I am trying to figure out what Combination Products are approved in the EU.

The definition for Combination products in the EU is a "combined advanced therapy product’ is defined as one that incorporates as an integral part one or more medical devices, or active implantable medical devices, and viable cells or tissues, or non-viable cells or tissues where the action on the human body of these cells or tissues is primary to the device." e.g. a drug eluting stent.

I have found the examples of combination products approved by the FDA for the U.S. market in this site: Examples of Combination Product Approvals

But I cannot find the European equivalent site.

Can anyone help me with this, please?

Cheers, F.
Hi

Please consult MEDDEV 2. 1/3 rev 3 MEDICAL DEVICES: Guidance document Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative as well as information available at the following European commission website

http://ec.europa.eu/consumers/sectors/medical-devices/documents/borderline/index_en.htm

Regards
S. Subramaniam
 

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