As many readers already know, there is an extreme lack of transparency when it comes to Notified Body capacity, timing, and fees.
Per Article 50 of the MDR and Article 46 of the IVDR, Notified Bodies are required to publish their fees.
However, this does not mean all Notified Bodies have done so and in cases where fees are published, the information can be difficult to find and understand. Many publish a daily and hourly rate, but no indication of the number of hours or days based on product types or other differentiating factors.
As Casus reported previously (HERE), the MDCG has also asked Notified Bodies to consider the needs of small-to-medium size companies when establishing their pricing. However, there is no understanding if the Notified Bodies have incorporated this into their fee structure.
Further, many have felt the pain of contacting Notified Bodies only to be told there is a 6-12 month waiting period, or that they are not taking on any new clients – or sometimes not receiving a reply at all. This even happens to manufacturers who are existing clients for that same Notified Body.
What is being done about this?
From a top-down approach, not much enforcement appears to be applied.
However, some in the industry are taking it upon themselves to increase transparency.
Capacity, Fees, and Overall Timing
One such company is Open Regulatory, which has created a Notified Body public review page, located: HERE
It includes a Notified Body capacity rating system and allows users to input anonymous feedback. Further, the user may input data such as their company size, their cost, and timeframes experienced.
Of course, personalized reviews are subjective, and unknown factors may apply to their feedback. Therefore, individuals should use their own judgment when reading reviews. However, it is still a great resource.
For companies struggling to be scheduled for their MDR/IVDR audits, this tool may provide alternative Notified Bodies to consider.
Open Regulatory’s resource allows individuals to enter the fees their company paid for certification. However, the information is anonymous and anecdotal.
A more verifiable resource is the table of Notified Body fees published by the company Qualitiso, located: HERE
The fees are broken down by different services, such as Technical File review versus Unannounced Audit. Where available, a source link directly to the Notified Body’s website is posted.
While there is still a long way to go, resources like the above are helping to close the information gap between industry and Notified Bodies.