Regulatory update: Europe’s Medical Device Regulation (MDR)

What is important to note for the preparation of Platelet-Rich Plasma (PRP) with respect to the new* MDR (Medical Device Regulation) 2017/745

Standard blood collection tubes for laboratory use bear the mark “IVD” as they are intended for in vitro diagnostic purposes only. The use of IVD tubes for PRP preparation means a change in their intended purpose. Healthcare professionals should use approved medical devices to prepare PRP in human use, this is a concern of safety and performance. This is applicable unless healthcare professionals justify to their competent health authority that no medical devices already available on the market can meet the needs of their patients.
Consequently, healthcare professionals are responsible for patient safety when using IVD tubes, or any other laboratory material, to produce their own PRP system instead of a certified medical device.

“Intended purpose” means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation. 

Only certified medical devices intended for PRP preparation, such as RegenLab devices, can be used to prepare PRP in respect of good practices and the MDR. 

For more information on how the MDR might impact your activities, consult the Factsheet for healthcare professionals and health institutions

Access to the complete text  of the MDR

RegenLab works continuously to produce adapted medical devices for the safe preparation of PRP for your patient and yourself. RegenLab kits allow the easy, quick and effective preparation of PRP in a closed circuit. 
More info about RegenLab medical devices: www.regenlab.com 

* fully applicable since May 26, 2021 

Bruno BOEZENNEC, MD, Managing Editor

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