The European Commission adopted a new measure to respond to the current COVID-19 outbreak.
With the agreement of the European standardization committees (CEN/CENELEC), number of harmonised standards were made freely available to those companies that are willing to start producing essential protective equipment like face masks and single-use gloves, even if this is not their primary activity. Freely available list of standards shall help EU and non-EU manufacturers to produce and place such products on the European market more easily while ensuring a high degree of safety.
Parallelly, many national legislative acts of the EU countries already envisage derogation clauses for extraordinary situations, such as the current threat to public health due to COVID-19 pandemics.
These derogations are essential, as some EU countries still require an additional medical device registration to be performed separately to the device notification to one of the European Competent Authorities.
Taking into account the current extraordinary situation that EU and non-EU countries are facing, we are calling on all industry actors to bring necessary and safe devices to the EU market, while we inform you of possible activation of derogation clauses that will allow the highly demanding life-saving products to enter the market significantly faster.
For example, such a derogative clause can be found in Article 14 of the Croatian Act on the implementation of Regulation on Medical Devices and Regulation on In Vitro Diagnostic Medical Devices (NN 100/2018). Upon reasoned request and with the consent of the Minister, the clause allows the competent Agency to authorize the placing on the market or use of those medical devices and in vitro diagnostic medical devices for which conformity assessment procedures have not been carried out, if this is in the interest of public health or safety or patient health.
Nika Gavrilovic, Ajda Mihelcic
Regulatory Affairs/Publishing Department
26/03/2020
Are you aware of which EU countries require additional, mandatory registration?
Obelis will gladly assist you, as well as with the request for the activation of derogation clauses for your devices!