17.04.2020

European Parliament votes for the postponement of the date of validity of the Ordinance on Medical Devices in the European Union

Background

On 17 April 2020 the European Parliament agreed with the European Commission's decision to postpone the date of validity of the Ordinance on Medical Devices.  

The Council of Ministers' consent is still pending only. Following the postponement, medical devices are allowed to be placed on the market in accordance with the existing legal framework for one further year.

Until the new date of validity of the ordinance on 26 May 2021, the  European Commission should use consistently the extra time saved by the postponement for, e.g., pushig forward with the missing (re-)certification of the notified bodies and also with providing missing legislative acts as well as recommendations.

Since the transitional periods will not change and further to the barriers created by the bottlenecks in the notified bodies the COVID-19 pandemic has been added, so producers should keep operating without delay.

The recertification of medical devices under the new legal framework collapsed factually due to this, in particular since no remote or remote audit is currently planned for these. This shortens the transition periods even more.

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