Classifying mushrooms into edible vs non-edible (or poisonous), can be a daunting task - most often ending as a pleasant meal, but sometimes a visit to the emergency room of your local hospital. In many ways, classifying mushrooms, resembles the classification of medical devices - it's not straightforward and the consequences of getting it wrong are substantial.
In the upcoming MDR, diligent experts in Brussels have scribbled down the classification rules in a way, it has to be said, that is not mutually exclusive and all inclusive - leaving us with some areas that are hard to decipher.
As an example, we can read in the classification rules (Medical Device Regulation, Annex VIII, Chapter III, §5.3 (Rule 7)):
All surgically invasive devices intended for short-term use are classified as class IIa unless they:
are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III ;
are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III ;
Which is kind of like saying “all cats have ears” followed by “all black cats have ears.” This, at its best causes confusion, and at its worst may end up something like devouring a freshly picked mushroom, only to end up in the ER.
There are many examples of companies that have mis-classified devices during development - causing much aggravation, cost, time, tears, and dismay due to “catch-up” or “overkill” when changing from one class to another. A well known publicly traded company actually used 2 years and over 10k Euros in consulting fees to be flip-flopped back and forward in believing their device was Class IIa, then Class III, then Class IIb, then finally Class III.
The rules for MDR are ambiguous and therefore we at Xybel have spent time in deciphering them into an understandable flowchart - and in the process, created an online tool for medical device companies to classify their devices. Click here to get started: MDR Classification tool.
We welcome questions and feedback at firstname.lastname@example.org.