Plenary Session: Medical devices

Medical devices (C9-0098/2020)

In 2017, a Regulation on medical devices was adopted (2017/745), which would come into force on 26 May 2020.

COVID-19 brought extraordinary circumstances that have required additional resources to deal with its effects, which could not have been anticipated when the Regulation was adopted.
The proposal, which I voted for, proposes to postpone the application of Regulation 2017/745 and the repeal of the corresponding directives for one year to ensure that Member States are able to comply with it. At the same time, they ensure that the application of an EU-wide derogation mechanism (which should be introduced with the new regulation) is applied as soon as this act enters into force.
The current legislation and the proposed new regulation enable the competent national authorities, upon duly justified request, to authorize the placing on the market of medical devices that have not been subjected to the assessment procedures stipulated because their use is of interest for the protection of public health or patient safety ('national derogation'). Regulation 2017/745 also allows the Commission, in exceptional cases, to extend the validity of a national derogation for a limited period of time to EU territory ('derogation at Union level').

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