Due to the outbreak of the Covid-19 in Europe, the European Union is registering increasing shortages of test kits and IVD-related devices. IVD manufacturers need to move fast to secure the supply of such devices on the European market.
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In response to the Covid-19 pandemic, the Portuguese government published legislation to increase the availability of Coronavirus-related products. Find out more here!
The European Commission has issued market and compliance guidance on regulatory requirements for manufacturers of medical face masks.
It is well known that for Medical and In Vitro Diagnostic Devices, the best tool easing the access to non-European markets is the Free Sales Certificate, which allows the manufacturer to prove the compliance of his devices with the EU laws and safety standards. These EU standards are then fully accepted and welcomed as the best possible ones also outside the European Union, typically as an official proof of compliance or generally to clear the Customs.
Due to the COVID-19 health emergency, France issued a Decree to ensure detection tests' availability. Find out more!
Different requirements apply for 3D-printed products, depending on their classification as MDDs or PPEs. Find out UK's Guidance in this article!
The European Commission issued a notice on the terms of the regulation of IP rights after the end of the transition period. Find out more in this article!
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.
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!
Find out in this article the latest guidelines concerning compliance of surgical and face masks, issued by the Belgian Competent Authority (FAMHP)