Companion diagnostics: legislation in progress

In September 2012, the European Commission adopted a proposal for a regulation on in vitro diagnostic medical devices which included certain specific provisions regarding the classification and conformity assessment of devices used in the context of personalised medicine, so-called companion diagnostics.

Meanwhile, the responsible committee on the Environment, Public Health and Food Safety (ENVI) published its report. On October 22nd the European Parliament voted on the Commission proposal and the amendments suggested by the committee and agreed on a new proposal which contains some significant changes affecting companion diagnostics.

A companion diagnostic is now defined more precisely as a “device specifically intended for and essential to the selection of patients with a previously diagnosed condition or predisposition as suitable or unsuitable for a specific therapy with a medicinal product or a range of medicinal products”.

While the first proposal left it to the Member States to determine which devices are subject to medical prescription, the latest version provides that companion diagnostics (among others) may only be supplied on medical prescription EU-wide. This means that companion diagnostics may not be advertised to consumers, because direct advertising to consumers of devices classed as prescription-only is considered to be illegal.

Regarding the general safety and performance requirements for companion diagnostics, the latest proposal stipulates that evidence of the clinical utility of the device for the intended purpose is required.

The rules regarding conformity assessment procedures have been equally amended.

In the conformity assessment procedure, based on full quality assurance and design examination, the opinion to be obtained from the competent medicinal products authority or the EMA has become more important. The Commission proposal vaguely stated that the notified body should give “due consideration” to the opinion. The new proposed legislation provides, however, that the notified body has to justify its decision if it deviates from the view expressed by the competent authority or the EMA and has to inform the Medical Device Coordination Group if no agreement is reached.

When it comes to a conformity assessment based on type examination, the proposed consultation with EMA was rejected at the suggestion of the ENVI. Instead, the European Parliament has followed the committee’s suggestion to oblige the notified body to request a scientific opinion by a reference laboratory.

The proposal agreed on by the European Parliament is the basis for negotiations with the Council in the coming weeks.

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