17 June 2016: adoption of the Regulation on In-Vitro Diagnostic (IVD) Medical Devices
The Regulation places increased responsibilities on Notified Bodies and device manufacturers, including in the area of follow-up on the quality, performance and safety of the devices placed on the market. We expect that these additional requirements will be challenging to implement for IVD manufacturers.
EBE’s and EFPIA’s focus in following the negotiations linked to the Regulation on IVD medical devices were companion diagnostics (CDx) that support healthcare professionals in their decision-making on tailoring treatments to patients, a key enabling aspect of personalised medicine.
The biopharmaceutical and pharmaceutical industry support the definition for CDx – Art. 2 (6) – clarifying that they are devices that are “essential for the safe and effective use of a corresponding medicinal product to:
– identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
– identify, before and/or during treatment, patients likely to be at increased risk for serious adverse reactions as a result of treatment with the corresponding medicinal product”.
With regard to the assessment of the technical documentation of CDx, Notified Bodies will now be required to consult the competent authorities for the authorisation of medicinal products, either at national level or the European Medicines Agency – EMA. The competent authorities are charged to determine the suitability of the device in relation to the medicinal product concerned. Whilst EBE and EFPIA support this new assessment route, the industry sees a need for more precision in the description of the interaction between Notified Bodies and competent authorities, directing the competent authorities’ involvement towards an assessment of the scientific validity of the CDx in relation to the medicinal product concerned.
Lastly, we regard the compromise reached on laboratory-developed tests (LDTs), also called in-house tests, as constructive. This will ensure that LDTs do not benefit from exemptions when their tests are manufactured on an ‘industrial scale’ – a term that still needs to be defined to avoid confusion. Furthermore, to benefit from the exemption, health institutions will now have to justify that the specific needs of target patient group cannot be met, or cannot be met at the appropriate level of performance by an equivalent device already available on the market.
A concern to the industry remains that the Regulation fails to explicitly mention Next Generation Sequencing (NGS) tests, an innovative technology that is likely to be used regularly in the future to help screen patients for a variety of biomarkers. Clarification on how the new legislation will regulate such tests would provide the regulatory certainty desired by industry.
Barbara Freischem, EBE Executive Director, said: “I am pleased that the Council and the Parliament Health Committee have finally reached an agreement under the strong leadership of MEP Peter Liese. This 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. 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.”
The European Biopharmaceutical Enterprises (EBE), a specialised group of the European Federation of Pharmaceutical Industries and Associations (EFPIA), is the European trade association that represents biopharmaceutical companies of all sizes operating in Europe. It has 50 member companies – majority of which are small and medium sized companies – engaged in the research, development, manufacturing and marketing of new medicinal products using biotechnology.
More information on EBE is available on the EBE website at http://ebe-biopharma.eu/.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 41 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.
Executive Director, European Biopharmaceutical Enterprises +32 2 626 25 64 firstname.lastname@example.org