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MDR Corrigendum 2 to expand grace period to Class IR devices?

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European rumour mill is busy at work talking up the prospect of a second corrigendum to the Medical Devices Regulation (MDR, 2017/745) being issued within the next few weeks, and that it will include an extension of the MDR Article 120 provisions to Class I devices that need to be reprocessed between uses (so-called ‘Class IR’ devices).

While no official communication from the Commission is available, many stakeholders ‘in the know’ are confident of this outcome, in order to relieve pressure on notified bodies, so they can focus on the higher risk Class III and implantable devices. Watch this space!

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