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Belgium temporarily bans the making available and use of rapid COVID-19 IVD self-tests

Belgium - March 25 2020 The Belgian competent authority (FAGG/AFMPS) has banned the supply and use of rapid diagnostic self-tests for the coronavirus (COVID-19) for six…

The European Commission has published Guidelines concerning the use of phthalates in medical devices

European Union - September 27 2019 The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published Guidelines concerning the use of…

Fabien Roy

Derogation procedures in the light of Brexit

Austria, Belgium, European Union, France, Germany, Greece, Ireland, Italy, Luxembourg, Poland, Spain, United Kingdom - September 4 2019 With the anticipated departure of the United Kingdom from the EU, medical device manufacturers are exploring whether it will be possible to continue…

Grégoire Paquet

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open!

European Union - August 7 2019 On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications…

Grégoire Paquet, Fabien Roy

European commission publishes Additional Guidance regarding the Medical Devices Vigilance System

European Union - August 5 2019 The three medical devices Directives, the Directive for Active Implantable Medical Devices (AIMD), the Directive for Medical Devices (MDD) and the In…

Grégoire Paquet, Fabien Roy