Notified bodies at the limit: How to get through the IVDR conformity assessment more easily

You need a conformity assessment by a notified body and have been waiting for a response for months or have possibly even been rejected? You are not alone in this!

Since the new regulation came into force, ten times more IVDs than before require testing and assessment by a notified body, while at the same time, there are fewer bodies designated for the IVDR! The resulting capacity problems are at the expense of many manufacturers.

In clear terms, notified bodies may reject or move a manufacturer's application to the back of the queue if there is uncertainty about the overall effort or concerns about a positive outcome.

Increase your chance of direct acceptance with the help of our IVDR Readiness Certificate!

Minimize the risk of rejection by a notified body - and thus jeopardizing your market access

We perform a mock conformity assessment of your QM system and an exemplary technical documentation. If both are of appropriate quality, we issue an IVDR Readiness Certificate that you can present to a notified body.

The independent audit by our experienced experts provides notified bodies with the assurance that no significant gaps in the documentation or process landscape are to be expected. The IVDR Readiness Certificate thus serves as proof that a conformity assessment can be carried out efficiently and in a resource-saving manner.

Save time and effort in the application process, so nothing stands in the way of a smooth testing and assessment

The application to a notified body follows strict regulatory requirements and can be time-consuming due to its scope and complexity. Our team is happy to support you and ensure that the application is completed correctly and that the submission is as efficient as possible.

The path to IVDR Readiness Certification

Can we help you with this?

Feel free to get in touch via our contact form to request a free consultation. One of our business analysts will get back to you as soon as possible to check in a joint preliminary discussion on whether and how we can best help you.

Do you have questions?

Perhaps these FAQs will help you:

We cannot give a guarantee because it is solely at the discretion of the notified bodies to determine the sequence of conformity assessments. However, the capacities of notified bodies are very limited, so conformity assessment procedures with an unclear outcome are often pushed back in the queue. Therefore, the probability of a timely assessment of your products and processes increases significantly if you demonstrate that a conformity assessment can be carried out without major problems and has a good chance of success.
No. We evaluate objectively and according to the same standards as a notified body. So if nonconformities are discovered that cannot be easily and quickly corrected, we cannot issue an IVDR Readiness Certificate. However, we will provide tips on how to resolve the nonconformities best.
The QM system's audit report and the technical documentation review document contain all identified deviations in detail. In addition, you will receive corresponding recommendations on how these deviations can be eliminated. Accompanying practical support in eliminating these deviations is not part of this offer. However, we can use the assessment as a basis to provide a more detailed offer based on your needs.
In this case, we offer you a separate pre-screening of the most important documents. The output is a report containing recommendations for action to be taken, if necessary, before you initiate a detailed assessment.

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