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Regulation of COVID-19 Tests in the EU: when do you need to involve a Notified Body?

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

Belgium follows the FDA's approach on the reprocessing of surgical masks and FFP2/FFP3 facemasks

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

Belgian AFMPS latest guidance in the context of COVID-19 outbreak

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

COVID-19- European Commission's recommendation on conformity assessment and market surveillance procedures

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

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