The EU market for medical devices is not fully harmonized, which means that you cannot rely on a medical device being a medical device everywhere in the EU. That, essentially, is what the European Court’s recent judgment in the Lycocentre case confirms. Confirms? Yes, it basically confirms what we already knew and that is that each EU member state can second-guess the regulatory qualification of your product to suit it’s own needs. In my own legal practice I’ve found that this happens quit [...]
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