Currently reading a novel in which the antagonists were utilising technology to create rogue waves on demand. Not a very good read, but I have found the science fascinating. Rogue waves are unusually large, unpredictable and suddenly appearing surface waves that occur where multiple physical variations cause waves to merge to create a single exceptionally large wave.

The idea of a “rogue wave” was my first thought when I read the following request for advice from a medical device manufacturer marketing in Europe:

This medical device manufacturer has certainly been hit by a large and unpredicted dilemma as a culmination of a series of circumstances – requirement to comply with MDR, lack of resources at the notified body (NB), and certification expiring. One would hope that this situation would be a one off.

Ever since MDR 2017/745 entered into force, there have been those who predicted manufacturers would remove vital devices from the marketplace due to the more strenuous requirements and also NBs would struggle with the increase in demand. The one-year extension was seen as the panacea for the whole of the industry.

If the above situation is not indeed a single unpredicted rogue wave, then medical device manufacturers, notified bodies, EU economic operators and the rest of the key stake holders have a duty to come together and galvanise a targeted request to the European Commission for action. The EC has always declared that the MDR was drafted to ensure the availability of safe and effective medical devices for the European public. Expedience from the EC is now essential to advocate safe sailing and calm waters for medical device manufacturers to maintain compliance.

If you too have been hit by a rogue wave, thus hindering your journey to MDR compliance, please do not remain quiet. A collective voice is needed to guarantee these uncharted waters include safe havens.

K Young

KimYoung@instem.com

References:

Elemed

Team NB survey 2021 https://www.team-nb.org/wp-content/uploads/2022/05/Survey-2021-20220516-1.pdf

By Katsushika Hokusai – Metropolitan Museum of Art, online database: entry 45434, Public Domain, https://commons.wikimedia.org/w/index.php?curid=2798407