LRQA dropping out as Notified Body
Notified body LRQA is dropping out of the notified body pool for medical devices and IVDs. This is especially a problem with respect to IVDs, as LRQA is one of the notified bodies traditionally handling a large share of the currently CE certified IVDs in the EU.
The blog article “Bottleneck of bottlenecks for notified body capacity” - Medical Devices Legal and regulatory blog – illustrates the case of LRQA that notified bodies are not only suffering in the end of the long tail, but also at the beginning of the tail.
Three things are happening:
- LRQA is ceasing its MDD and IVDD services which means its current customers need to transfer to another notified body.
- LRQA is abandoning its pursuit of a notified body in the Netherlands. Their Brexit hedge is terminated and less of the current capacity of notified bodies in the UK ends up being transferred to the EU27, so less total capacity available.
- LRQA announces they are not pursuing their MDR and IVDR notification. This capacity will not be available for the IVDR transition, which is a pity given the enormous amount of currently non-CE certified IVDs that need to be CE certified under the IVDR.
So, we are faced with the scenario that notified body capacity is rapidly decreasing, and a lot faster than new capacity is being added.
Predicted is LRQA will not be the last notified body to abandon medical devices altogether.
You can read the full blog “Bottleneck of bottlenecks for notified body capacity” on the website of Medical devices legal and regulatory blog.