Article 59 COVID-19, Derogation of CE Mark in EU state

Join us January 26, 2021, 9:30 - 10AM ET | 2:30 - 3:00PM GMT

Presented by Ronald boumans 

On April 23rd, 2020 Regulation (EU) 2020/561 amending Regulation (EU) 2017/745 on Medical Devices (MDR) introduced a one year delay in the date of application of the MDR. It also changed Article 59 MDR:
  • Until the MDR applies, also the current directives are brought within the scope of Article 59.
  • While the MDR applies from May 26th, 2021, Article 59 will apply from April 24th, 2020.

Article 59 sets out how for medical devices (not IVDs) the authorization of derogation of the CE-marking requirement can be done. In the light of the COVID-19 pandemic it may be justified to speed up the paperwork for devices that are being placed on the market, while at the same time notified bodies are struggling to perform audits and reviews while travel restrictions apply.

Join us as we provide useful guidance and a framework for those that have a suitable device, without raising unrealistic expectations for navigating Article 59. 

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