New EU measures relating to export and approval

The EU Commission has taken several measures during the last few days in order to handle the COVID-19 outbreak and to ensure sufficient supply of medical devices and equipment within the EU.

As a result, the EU Commission has, inter alia, on 13 March 2013 issued a recommendation opening the EU market to protective equipment manufactured in accordance with WHO recommendations rather than in strict adherence to EU standards and asked that Member States use their discretion to authorise derogations from EU conformity assessment procedures. Further, the EU Commission on 15 March 2020 imposed an export ban for certain medical protective equipment in order to ensure sufficient supply within the EU. The ban will be effective for a six week period.

Read more about these measures here and here.

You can contact Director Rasmus Vang and Attorney-at-Law Emilie Lerstrøm for questions.

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