Since early this year, the COVID-19 virus substantially affects our daily life. Testing for the presence of or past exposure to the virus is an essential aspect of combatting the COVID-19 outbreak and a number of companies...more
10/22/2020
/ AFMPS ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
EU ,
EU Directive ,
Infectious Diseases ,
Medical Devices ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Agenda ,
Virus Testing
The European Commission today announced that it is preparing a proposal to postpone the entry into application of the new Medical Devices Regulation (MDR). The proposed postponement would be for one year....more
Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more
The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively....more