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Covid-9 emergency: the European Commission works on proposal to postpone Reg. (EU) 2017/745 application of one year

On 25 Mach 2020, in full Covid-19 emergency, a note was released by the European Commission where they announced they had started working to postpone the full application of Regulation (UE) 2017/745 on medical devices, taking over from Directive 93/42/EEC.

The ongoing pandemic seems to be the driving reason for the proposal. The Commission has in fact explained this decision as intended to relieve the pressure weighing on national authorities, notified bodies, manufacturers and other business operators currently engaged in complying with the new European provisions expressed in the Regulation.

All the above mentioned subjects will therefore be given the chance to concentrate on the urgent matters arising from Covid-19, as stated in the Commission note.

Full application of the Regulation text was expected on 26 May 2020, but should the Commission proposal become effective, it would be postponed to May 2021 with a consequent extension of the deadline for the conformity of devices and operators. The document drafted in these days also informs on the time expected for the proposal to be discussed by the European Parliament and Council, fixed on early April.

The same kind of postponement was believed to be beneficial by many associations long before the onset of the Covid-19 emergency, also considering the postponement of the date when the European database EUDAMED is supposed to become operative, put off to the same date of application of Reg. (EU) 2017/746 on in vitro diagnostic medical devices (26 May 2022).

Another factor pushing associations to support a time extension could be the small number of Notified Bodies designed so far for the Regulation – only 12 – compared to the 20 bodies initially expected due to the imminent application.

Just before the Commission note, Medtech Europe – an association of companies in the sector of diagnostics, biomedical aids, and national associations – had also joined the choir, asking the Commission to stop the Regulation application to reprise it at least 6 months as of the end of the emergency, to be established by a declaration of the World Health Organisation (WHO) on the end of the pandemic.

Writtean By: Riccardo del Signore