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
On 3 April 2020, the European Commission issued a guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices ("IVD") in the COVID-19 context....more
The Belgian federal agency for medicines and health products (AFMPS or FAGG) provides that Belgium acts as a logistical platform for certain medicinal products....more
Following requests from numerous Member States, on 3 April the European Commission (“Commission“) adopted Commission Decision (EU) 2020/491 (“the Decision“), which provides for relief from import duties and VAT for goods...more
Given the challenges in maintaining the supplies of healthcare materials such as surgical masks and FFP2 and FFP3 face masks, the Belgian Task Force on shortages, a working group set up by the Belgian Federal Agency for...more
In response to the global outbreak of the COVID-19 virus, the EU and various member states have taken measures to ensure continuity of supply of personal protective equipment (PPE) and address shortages of healthcare...more
The Belgian Federal Agency for Medicines and Health Products (AFMPS) released a series of guidance and recommendations over the last few days in relation to the COVID-19 outbreak. ...more
On 16 March 2020, the European Commission published Recommendation (EU) 2020/403 of 13 March on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. The objective of the...more