Medical device

A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used in humans for specific medical purposes, such as the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means. The definition is laid down by Regulation (EU) 2017/745, applicable since 26 May 2021, which replaced the earlier directives. The criterion of the principal mode of action separates the device from the medicinal product.

Classification and placing on the market

Devices are divided into four risk classes, I, IIa, IIb and III, according to rules that take account of the duration of use, invasiveness and the part of the body concerned. Placing on the market is based on a conformity assessment, without prior administrative authorisation, which leads to CE marking and requires, for most classes, the involvement of a notified body. The manufacturer must base conformity on a clinical evaluation, maintain technical documentation and carry out post-market surveillance. The transition periods to the Regulation were extended in 2023, until the end of 2027 or 2028 depending on the class, subject to conditions.

Software as a medical device

Software may constitute a medical device in its own right where its manufacturer intends it for a medical purpose, for example to assist diagnosis or therapeutic decisions. The Regulation devotes a specific classification rule to it, which often results in a class higher than class I. Software based on artificial intelligence may also fall within the Artificial Intelligence Act, which classifies it among high-risk systems where it is subject to assessment by a notified body.

Medical devices and patents

Medical devices are patentable under the ordinary conditions, since the exclusion of methods of treatment does not extend to products used to carry out such methods. The supplementary protection certificate is, however, unavailable to them, in the absence of a marketing authorisation granted under medicinal products legislation, and the application of the Bolar exemption to trials conducted with a view to CE marking remains debated. Disputes in the sector therefore focus mainly on the patent itself, often on successive improvements, and on provisional measures, which are decisive in markets with short product cycles.

Key points

A medical device differs from a medicinal product by its principal mode of action, which is neither pharmacological, immunological nor metabolic. It reaches the market through CE marking, without prior authorisation, after a conformity assessment proportionate to its risk class. The class of the product, including software, should be checked at the design stage, and a supplementary protection certificate should not be counted on to extend exclusivity.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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