The European Commission has issued market and compliance guidance on regulatory requirements for manufacturers of medical face masks.
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Free Sales Certificates needed for medical device registration in Bosnia and Serbia
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.
Faster access of IVDs on the French market
Due to the COVID-19 health emergency, France issued a Decree to ensure detection tests' availability. Find out more!
AEMPS Information about market campaign control for sunscreen products
The AEMPS started a market control campaign for sunscreen products in relation to SPF. Read all the details in this article!
UK’s Guidance on 3D printing of medical devices or component parts during the pandemic
Different requirements apply for 3D-printed products, depending on their classification as MDDs or PPEs. Find out UK's Guidance in this article!
Update – Brexit transition- what about IP rights?
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!
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.
Labeling guidance for hydroalcoholic gels published by the Spanish Agency of Medicines and Medical Device (AEMPS)
The Spanish Agency of Medicines and Medical Device (AEMPS) has published guidance on labeling and safety instructions for the use and preservation of hydroalcoholic gels and solutions.
Hydroalcoholic gels/solutions are classified as biocides or cosmetics depending on the primary function of the product, claims and the content of alcohol.
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)