ESA prolongs a recommendation to prevent delays and ease market access for protective equipment and medical gear*
The EFTA Surveillance Authority (ESA) has today decided to amend and prolong its Recommendation on conformity assessment and market surveillance procedures , in order to continue to make it easier for medical devices and personal protective equipment (PPE) to be placed on the market.
ESA’s decision has been taken to continue to help facilitate national and international efforts to curb the ongoing COVID-19 pandemic and ensure that medical gear and PPE are made available to those who need it the most.
EEA law requires conformity assessments and marking of medical devices and personal protective equipment before such products can be imported and sold on the EEA market. Conformity assessments are necessary for covering equipment such as face masks, droplet-resistant gowns or nose swabs, to ensure the safety of health workers and the public, but can be a time-consuming process.
Today’s decision follows a Recommendation issued on 24 March 2020. Among the recommendation are suggestions for quicker conformity assessments for new PPE products, but also a recommendation to the EEA EFTA States to consider the possibility of derogations from standard market-approval procedures for medical equipment.