AUTHOR
Francesca Di Giuseppe is a senior quality assurance and regulatory affairs specialist working with medical device and in vitro diagnostic manufacturers. She has worked in the field since 2015, in Italy and in the United States, across certification, manufacturing and independent consultancy.
Rule 11 reclassified an entire industry. Software that was Class I under the directives is Class IIa or higher under the Regulation — and the threshold between IIa, IIb and III turns on a single question most people answer too quickly.
For most devices the answer follows mechanically from the class. The exceptions are where it gets expensive: three sub-categories of Class I pull a Notified Body back in for one narrow aspect, and being self-declared has never meant being unregulated.
Two regulations, adopted the same day, with different class letters, different rules and different consequences. The line between them is narrower than most people expect — and getting it wrong means every decision downstream was made under the wrong framework.
Europe gives you twenty-two rules and expects you to apply them. The United States gives you a catalogue of roughly six thousand generic device types and expects you to find yours. Everything that follows — the class, the review pathway, whether you need a predicate — is read off the entry you land on, which makes finding the right one the whole job.
Great Britain did not inherit the MDR. It kept the Medical Devices Regulations 2002, which carry the old directive across almost unchanged — eighteen rules, not twenty-two, and no Rule 11 for software. Anyone who learned classification on the Regulation will get Great Britain wrong in a predictable direction.
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