Do we need clinical trial data for Class IIa medical device under MDR

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Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#2
We are a start-up with a class IIa and we were required to submit clinical data. IIRC it was about 50 pages of clinical data. CER.
 

dgrainger

Trusted Information Resource
#4
You need to perform a clinical evaluation - have a look at Article 61 of the MDR.

If you can find relevant scientific literature on an "equivalent" device then you probably don't need to perform a clinical investigation.
 

SKM.Sunil

Involved In Discussions
#5
Will a startup developing new Class IIa medical device need to provide clinical trial data?
No need to conduct clinical trial, until unless your device is new invention and don't have a predicate in market with CE mark.

if your device is equivalent to any available device then you need to compile clinical data in CLINICAL EVALUATION.
here you can compile clinical trial data related to equivalent device.
 

Ellison

Starting to get Involved
#8
Keep in mind that you must have access to all technical data if you are stating your device is equivelant to another device already on the market.
 
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