Notified Body Spare Capacity Is A Moving Target And Difficult To Pinpoint

As the medtech industry’s demand for EU notified body auditing services continues to grow, uncertainty continues as to where availability lies. But industry could help testing bodies in their planning.

Many arrows missed hitting target mark. Shot miss. Multiple failed inaccurate attempts to hit archery target. Business challenge failure metaphor. Flat cartoon isolated vector object illustration — • Source: Shutterstock

Notified bodies may have some spare capacity to take on board new applications for assessing the conformity of products that fall under the scope of the Medical Device Regulation (MDR) and IVD Regulation (IVDR), depending on the codes concerned.

However, capabilities in specific codes are “definitely a moving target,” according to Françoise Schlemmer, director of the EU notified body...