Updated as of 13 April 2020
YOUR REGULAtory news during this pandemic
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.
TEMPORARY EXTRAORDINARY MEASURES RELATED TO MEDICAL DEVICE NOTIFIED BODY AUDITS DURING 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.
CONFORMITY ASSESSMENT PROCEDURES FOR 3D PRINTING AND 3D PRINTED PRODUCTS
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.
EU COMMISSION ISSUES QUESTIONS AND ANSWERS TO HELP INCREASE PRODUCTION OF SAFE MEDICAL SUPPLIES
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.
