Different requirements apply for 3D-printed products, depending on their classification as MDDs or PPEs. Find out UK's Guidance in this article!
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Personal protective Equipment and Medical Devices in the Covid-19 context –how can they be lawfully placed on the EU market?
The Covid-19 pandemic created a huge demand for PPEs and MDs, but how can you place them on the EU market lawfully? Read the detailed explanation here.
National MDR implementation – Germany’s establishment of NAKI
Germany established NAKI, the National Working Group for the Implementation of the new EU Regulations on MDR IVDR. Read all the details in this article!
Coronavirus: updated guidelines for verifying the compliance and suitability of surgical face masks
Find out in this article the latest guidelines concerning compliance of surgical and face masks, issued by the Belgian Competent Authority (FAMHP)
Guidance for placing hand sanitizing products on the UK market
In May 2020, the Office for Product Safety & Standards issued a guidance for the placement on the UK of hand cleaning and sanitising products.
The demand for these type of products has risen, as a consequence of the COVID-19 pandemic, and it is common for manufacturers and importers to be confused when it comes to which legislation these products fall under.
MHRA regulatory flexibilities resulting from coronavirus (COVID-19)
The government of the UK has published on its official website some regulatory flexibilities resulting from coronavirus.
‘Free of’ claims – guidance and recommendations from the French Competent Authority (ANSM)
The French Competent Authority (ANSM) has published some guidelines on cosmetic claims affixing. Read all the details here!
Indigofera tinctoria as hair dye ingredient: is it safe?
In 2003 the EU Commission requested to evaluate the safety of Indigofera Tinctoria in cosmetic products. Find out the SCCS's final opinion in this article!
COVID-19 PPE WEBINAR: How to sell PPE in Europe?
Due to the outbreak of the COVID-19 in Europe, the European Union was registering increasing shortages of Face Masks and other PPE-related equipment; PPE manufacturers needed to move fast to secure the supply of such equipment on the European market.
Belgium has identified a list of COVID-19 critical devices, which devices are on the list?
The Belgian FAMHP issued a guidance document listing critical devices for health systems during the Covid-19 pandemic. Find out what is on the list here!