EU: Public consultation regarding the revision of Directive 98/79/EC on in vitro diagnostic medical devices

28 July 2010

Marc Martens

On 29 June 2010, the European Commission launched a public consultation on specific issues relating to in vitro diagnostics.

The two other medical devices Directives (Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices) were revised by Directive 2007/47/EC, and the need to revise Directive 98/79/EC was revealed by the public consultation that launched in 2008. Directive 98/79/EC has not been substantially amended since its adoption in 1998.

The questions in the consultation aim to address technological progress and the emerging weaknesses identified regarding key elements of the regulatory framework. The topics addressed are as follows: 

  • the need for implementation of a risk-based classification and conformity assessment procedures;

  • the need to review or limit the specific exemption for “in-house tests”;

  • the increase of the requirements regarding clinical evidence for in vitro diagnostic medical devices;

  • due to the  increasing number of tests which are performed within an economic operator's facility without placing the in vitro diagnostic medical devices on the market, the Commission has considered amending the definition of "putting into service" to make it clear that it also covers in vitro diagnostic medical devices that are not placed on the market but used for the delivery of results within the Community; and

  • the need for an extension of the scope of the Directive to all genetic tests by adding a specific provision into the definition of in vitro diagnostic medical devices regarding devices which pursue the purpose of providing information concerning “results obtained by analysis of the genome”. Indeed, only genetic tests that have a medical purpose are covered by this Directive and there are increasing concerns regarding some genetic tests (e.g. direct to consumer genetic tests and predictive tests), including genetic tests without a clear medical purpose. These concerns are related, among others, to the lack of quality, scientific evidence and clinical validity or clinical utility of these tests.

Any comments and information on this public consultation should be submitted by mail, fax or email by 15 September 2010 at the latest to DG SANCO.