Regulatory Open Forum

What's the typical review timeline for EU MDR certification review for Class IIb, Class III devices? Is there significant delay than the initial expectation/ proposal?

Hi Anon

The time taken depends on various factors. When I said various factors, I include the following (not exhaustive): which Notified Body, which product code(s) (so which technical specialists will be needed, the more complex the product, the more specialists may be involved), novelty of your product (e.g. is CECP applicable), the completeness of the submission (and then the number of questions raised by the NB reviewer and the time it takes the manufacturer to respond to the questions).  

The survey data published by the Commission on applications and certifications can now be seen in a publicly available dashboard. You would be looking under the Temporal & Qualitative tab. I believe that the data presented is the time taken for the review from when it starts, so does not include the time between signing agreements and waiting for the review to start. That waiting time depends on the Notified Body and the product codes; e.g. BSI have publicly talked about there being queues for orthopaedic and dental reviews to start, whereas other product codes have no and minimal wait times.

What's the typical review timeline for EU MDR certification review for Class IIb, Class III devices? Is there significant delay than the initial expectation/ proposal?

Anon,

As others have said it depends upon the Notified Body you are working with. Currently, the MDR submission I am working on took 3 months for agreements, and the NB has communicated roughly a year for review. The device is a Class IIb active device.

Edward,

Perusing my daily RAPS forum email and saw the dashboard you linked. This was very insightful. How were you notified that the dashboard existed?

Hi Anon

The time taken depends on various factors. When I said various factors, I include the following (not exhaustive): which Notified Body, which product code(s) (so which technical specialists will be needed, the more complex the product, the more specialists may be involved), novelty of your product (e.g. is CECP applicable), the completeness of the submission (and then the number of questions raised by the NB reviewer and the time it takes the manufacturer to respond to the questions).  

The survey data published by the Commission on applications and certifications can now be seen in a publicly available dashboard. You would be looking under the Temporal & Qualitative tab. I believe that the data presented is the time taken for the review from when it starts, so does not include the time between signing agreements and waiting for the review to start. That waiting time depends on the Notified Body and the product codes; e.g. BSI have publicly talked about there being queues for orthopaedic and dental reviews to start, whereas other product codes have no and minimal wait times.

What's the typical review timeline for EU MDR certification review for Class IIb, Class III devices? Is there significant delay than the initial expectation/ proposal?

What's the typical review timeline for EU MDR certification review for Class IIb, Class III devices? Is there significant delay than the initial expectation/ proposal?