MDR validation medical devices - Performance and Functionality Testing

[Belen Sanchez]

This doubt is about a medical device in development, to be marketed in the EU under the CE mark MDR: I have a doubt about if it's possible to do performance testing with a prototype of a medical device classified as class IIa with patients (under realistic conditions). With MDD/ and following ISO 13485 these tests were performed as part of the validation of the design, so a prototype of the medical device was delivered to a health professional to check its performance following the protocol from the manufacturer. But I have been informed that now under MDR these performance testing with prototypes are not possible, anyone can help me?


Thanks in advance

 

[yodon]

From the description, it sounds like this is clearly being framed as design validation (just to be sure there's no intent for design verification); i.e., the effort is to help support your assertion that you are meeting user needs and intended use.

13485 is pretty clear: "Design validation shall be conducted on representative product. Representative product includes initial production units, batches or their equivalents. The rationale for the choice of product used for validation shall be recorded"

If you can assert that the 'prototype' is production-equivalent, then it should be fine (and maybe the hangup is just terminology; i.e., prototype -v- production equivalent). If it's really a "run it up the flagpole" from something cobbled together in someone's garage situation, then, yeah, you probably can't justify that it's production equivalent and can't use the data for validation.

I *don't think* the MDR has anything to add but I may be wrong.

 

[Billy Milly]

"MDR" would say this is a clinical investigation (real-life use of yet non-CE marked product).

 

[Orca1]

According to ISO 13485:2016, design and development validation should be performed to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. This validation should be conducted on representative product, which includes initial production units, batches, or their equivalents. The rationale for the choice of product used for validation should be recorded.

As part of design and development validation, the organization should perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements. A medical device used for clinical evaluation or performance evaluation is not considered to be released for use to the customer.