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//Select CountryKeeping you updated on the latest regulatory news
Updated as of 13 April 2020
In this time of need and urgency, various authorities all over the world are releasing news and documents specifically to the virus outbreak. Get concise information on the latest European Commission regulations and standards on medical supplies and devices that is related to COVID-19.
The European Commission published a new MDCG paper giving guidance on remote audit activities under the Medical Device Directive and Medical Device Regulation. This documents states that in general, initial certification audits have to be performed on-site, however exceptions can be made for COVID-19 relevant devices/certificates.
Find out more here.
This guidance is for 3D printed products to be used in a medical context for the current pandemic COVID-19 situation.
Find out more here.
The Commission is releasing guidances to assist manufacturers in the production of essential medical supplies and equipment in three areas: the production of masks and other personal protective equipment, leave-on hand cleaners and hand disinfectants, and 3D printing in view of the virus outbreak.
Find out more here.
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