In vitro diagnostic medical device

An in vitro diagnostic medical device is any medical device which is a reagent, calibrator or control material, kit, instrument, apparatus, software or system, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, in order to provide information on a physiological or pathological process or state, a predisposition, an impairment or the likely response to treatment. Its regime is laid down by Regulation (EU) 2017/746, applicable since 26 May 2022, which replaced Directive 98/79/EC.

Classification and assessment

The Regulation divides devices into four classes, A, B, C and D, in ascending order of risk to the patient and to public health. Whereas most devices escaped third-party involvement under the former Directive, a notified body is now involved for most devices in classes B, C and D. The manufacturer must demonstrate the scientific validity and the analytical and clinical performance of its device. The transition periods have been extended and staggered according to class, to take account of the limited capacity of notified bodies.

Companion diagnostics and in-house devices

A companion diagnostic, which is essential for the safe and effective use of a medicinal product, for example to identify patients likely to respond to a targeted therapy, falls within class C. Its assessment by the notified body requires consultation of the European Medicines Agency or of the national competent authority for the medicinal product concerned. Healthcare institutions may also manufacture and use devices in-house, without CE marking, under strict conditions, in particular the absence of an equivalent device available on the market.

Diagnostics and patents

The exclusion of diagnostic methods applies only if all the technical steps are carried out on the human body, so that methods performed on samples taken from the body remain patentable. Patents on biomarkers, sequences or analytical methods often fall under the regime for biotechnological inventions and raise questions of inventive step where the claimed correlation results from the application of known techniques. Pairing a medicinal product with its companion diagnostic calls for coordinated patent strategies for both products.

Key points

The 2017 Regulation has substantially strengthened control of in vitro diagnostic devices, extending notified body involvement well beyond class A. A companion diagnostic ties the fate of the device to that of the medicinal product it accompanies. The class of the device and the applicable transitional deadline should be checked, and, for a targeted therapy, the regulatory timetable should be aligned with the patent protection of both the medicinal product and the test.

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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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