Separate Consideration of surgical sutures under the Medical Devices Regulation (MDR) – EASSI publishes new position paper

The MDR Working Group of EASSI – The European Association of the Surgical Suture Industry has published a new position paper on surgical sutures and their clinical evaluation within the MDR. In the paper it is stated that the level of clinical evaluation must be adjusted to the risk and nature of surgical sutures.

With regards to surgical sutures and their level of clinical evaluation EASSI’s MDR Working Group sees a need for change. Heiko Riedel, Chairman of the Board says:

“With surgical suture’s acknowledged special status, they should be included in the scope of Article 61 (10) MDR irrespective of their risk classification and should be exempted from the requirements of clinical data.”

Suitable control measures are in place to appropriately mitigate the risks to health and include as crucial element the demonstration of compliance with the monographs of the European Pharmacopoeia.

You can find further information in the position paper.