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Telemedicine becomes a reality in France

Eveline Van Keymeulen

In September 2018, French Decree 2018-788, which sets out the conditions to provide telemedicine acts, entered into force. The Decree was adopted pursuant to Article 54 of the 2018 Social Security Financing Bill. It exempts health care professionals conducting a medical follow-up of patients over long distances (tele-monitoring) from obtaining, as required by Article R. 161-43 of the Read More

Dutch authorities to investigate possible inducement payments in medical devices sector

Iradj Nazaryar

The Dutch Health and Youth Inspectorate (HYI) has announced plans to investigate possible inducement payments in the medical devices sector. The investigation, which will start in the autumn of 2018, will focus on cardiology, orthopaedics and dental implants by looking into the service contract meetings that suppliers may have concluded with healthcare professionals. Moreover, suppliers Read More

Belgian report shows limited success in screening of health insurance funds

Veerle Pissierssens

A recent report from the Belgian Court of Audit reportedly shows that the information that health insurance funds must disclose pursuant to the requirements set in the 2016 “Future Pact” (Toekomstpact), which mainly pertain to internal inspections and accountancy, is too fragmented and therefore of little use. The report also recommends granting inspection services access to Read More

Getting ready for the EU MDR: New guidance documents available for manufacturers

Eveline Van Keymeulen

During the summer months of July and August, the European Commission has published five documents aimed at guiding manufacturers and other economic operators through the changes implemented by the EU Medical Devices Regulation (MDR) and the EU In-Vitro Diagnostic Medical Devices Regulation (IVDR). Both regimes will be fully applicable on 26 May 2020 and on 26 Read More

ECJ: organisms obtained by new mutagenesis plant breeding techniques are not exempted from the GMO Directive

Sophie ten Bosch

Today, the European Court of Justice (ECJ) has decided in case C-528/16 that organisms obtained by new mutagenesis plant breeding techniques are genetically modified organisms (GMOs) and subject to the obligations laid down in the GMO-Directive (Directive 2001/18/EC). This decision interprets the GMO-Directive in light of new plant breeding techniques such as CRISPR-Cas9. Mutagenesis is Read More