Clinical evaluation for a class IIa medical device - EU MDR Requirements

[Susan]

Hello,

Our company has an EC certification of a class IIa device under MDD and we are considering to continue putting it on EU market under MDR.

Recently in seminar we`ve heard that to comply with MDR`s requirements on clinical evaluation, a paper of this device is necessary (at least one paper) and this paper should be published on a medical journal, which is known and accepted by EU.
But I couldn`t find any contents about this in MDR.
Any opinions about this?

Thanks!

 

[Marcelo]

.
Recently in seminar we`ve heard that to comply with MDR`s requirements on clinical evaluation, a paper of this device is necessary (at least one paper) and this paper should be published on a medical journal, which is known and accepted by EU.
But I couldn`t find any contents about this in MDR.
Any opinions about this?

Thanks!

People who told you that seems to not understand the requirements and expectation of clinical evaluation. For a clinical evaluation, you need robust clinical data to show that the specific essential requirements (or General Safety and Performance Requirements as they are now called in the MDR) have been fulfilled. The data can be from several sources, including published papers. But they also need to be evaluated. Having a published paper (or a thousand) does not help if the data is not scientifically and statistically sound and it does not link to the specific requirements.

Also, see meddev 2.7.1 Rev 4.

 

[Remus]

You may not need any clinical data (performance) if your product have harmonised standards. You can show complience to that standards. However you should perform literature search and find device risks...

 

[Marcelo]

You may not need any clinical data (performance) if your product have harmonised standards. You can show complience to that standards. However you should perform literature search and find device risks...

I would take care with this statement when talking about the MDR. The MDR clearly separate between clinical performance and clinical benefit. if the product has harmonized standards AND the standards have requirements for clinical performance (several do not have these requirements), you may show compliance with the related essential requirements (particularly the performance one) by using these harmonized standards. However, standards do not cover clinical benefits, and you still need clinical data on them).