Medical devices are grouped into risk classes in every major market — Class I, II and III in the US under the FDA, broadly similar Class I/IIa/IIb/III groupings under the EU's MDR — and the class determines what evidence is needed before the product can be legally sold, not just how it is tested. A Class I device like a simple bandage clears with comparatively light documentation; a Class II or III device needs a cleared regulatory submission (510(k), CE technical file under a Notified Body, or equivalent) before import, which is a buyer-side regulatory process that exists entirely separate from the shipment itself.
PPE sits in its own bracket, sometimes regulated as a medical device and sometimes under separate product safety rules depending on its intended use — a surgical mask intended for clinical use is typically treated differently from an equivalent mask sold as general public protection, even if the physical product looks the same.
From a logistics standpoint, the practical risk is booking freight before the regulatory file is actually in hand. A Class II/III device shipped before its clearance is confirmed can arrive and sit in bonded storage, unable to clear for sale, which turns a freight cost into a demurrage and storage cost on top.
We do not advise on regulatory classification or submissions — that sits with the importer's regulatory affairs function or consultant — but we do hold a shipment's booking until the buyer confirms the clearance status, specifically to avoid that scenario.