Industry welcomes European diagnostics regulations

Industry bodies have welcomed new European medical device legislation, which they say will support greater use of companion diagnostics and personalised medicines.

The Regulation on In-Vitro Diagnostic (IVD) Medical Devices was agreed by the European Council and Parliament alongside wider med device reforms, brought in in the wake the PIP breast implant scandal.

The European Biopharmaceutical Enterprises (EBE) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) voiced qualified support for the new IVD regulations.

Though described as a “compromise agreement”, the trade bodies gave their approval in a joint statement, saying medical devices are “essential for the safe and effective use of a corresponding medicinal product”.

Barbara Freischem, executive director of EBE, commented: “I am pleased that the council and the Parliament Health Committee have finally reached an agreement under the strong leadership of MEP Peter Liese.

“The legislation will provide a firm basis for a rapid expansion in companion diagnostics and personalised medicine, which offers huge potential for patients and public health.”

However, the two trade bodies anticipate the added safety checks will be “challenging to implement for IVD manufacturers”.

In addition to increased emphasis on follow-up quality, performance and safety of marketed devices, the new rules also require consultation with national or European regulators on a device's suitability in relation to the drug prior to any license application.

EFPIA and the EBE also have expressed concern over the lack of guidance for the process, and called on the European Parliament Health Committee to provide clear direction for how a companion device's “scientific validity” will be evaluated.

Additionally, the EBE and EFPIA identified Next Generation Sequencing (NGS) tests - used to screen patients for biomarkers - as another area in which further detail on how the new legislation will regulate such tests is required.

Freischam added: “Clarifications are still needed on a number of topics and the biopharmaceutical industry will remain actively engaged to ensure that the regulation reaches its goal for the benefit of patients.”