Different requirements apply for 3D-printed products, depending on their classification as MDDs or PPEs. Find out UK's Guidance in this article!
Personal protective equipment (PPE)
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.
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)
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.
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.
Conformity assessment procedures for COVID-19 protective equipment
Contact us today how we can help you ensure compliance of your products!
How is protective clothing regulated in the EU?
To find out more about how Obelis can help in making sure your protective products are compliant, talk to our team!
COVID-19: Free European standards and easier MD & IVD registration
Europe adopts new measures to respond to COVID-19 outbreak, including measures to speed up MD & IVD device EU market introduction and free info on EU standards.
COVID-19 outbreak: The European Commission proposes faster access of PPE and medical devices to the EU market
In the context of Covid-19 global outbreak, the European Commission (EC) published a Recommendation(EU) 2020/403 to the manufacturers, Notified Bodies and Competent Authorities on conformity assessment and market surveillance procedures to address the continuously increasing demand of PPE such as face masks, gloves, protective coveralls or eyewear protection and medical devices such as surgical masks, exploration gloves and some gowns on the EU market.
Consequences of Non-Compliance
Full adherence to all compliance-related matters is a hugely important part of introducing a product to the European Market – or indeed maintaining its position there. Each category of CE Marking certifiable product has its own set of regulations or directives, from medical devices to personal protective equipment to toys, and electromagnetic devices to construction products and motor vehicles.