Custom-made implants (Class IIb) and pre-commercialization clinical trials in Spain

JoselVLC

Starting to get Involved
#1
Hello,

I would appreciate if you could inform about the need (or not) to perform pre-commercialization clinical trials (clinical studies) for a Class IIb custom-made implant in Spain.

Thank you.
 
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indubioush

Quite Involved in Discussions
#2
You need some regulatory oversight on this. How are you validating your design? Is this a compassionate use case? Too many questions.
 

JoselVLC

Starting to get Involved
#3
You need some regulatory oversight on this. How are you validating your design? Is this a compassionate use case? Too many questions.
Hello indubioush,

The designs will be validated with preclinical tests (mechanical, in silico with finite element models). These will not be a compassionate use. Products will be manufactured by a company with ISO 13845.
 

indubioush

Quite Involved in Discussions
#4
I wish I could help you more, but I don't know enough about this topic. I suggest you talk to a Regulatory person to be safe.

Also, when you say the products will be manufactured by a company with ISO 13485, it sounds like you are using a contract manufacturer. Regardless of whether you use a contract manufacturer, you will have regulatory responsibility over your product. You will have to ensure that your product meets the essential requirements of the 93/42/EEC.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Custom-made devices have their own rules and clauses in the EU regulations (MDD/MDR).
It's important to verify that the device actually meets the official definition of "a custom-made device". It's not always trivial.
I'm available for a closer look if needed.
Ronen.
 
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