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Question about requirements

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Guest user Created:   May 25, 2021 Last commented:   May 26, 2021

Question about requirements

We have extended our MDD and I have done a gap analysis according to CAMD Transition Sub Group
Specifically Section III.
But I'm now wondering are there other requirements that I'm missing?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić May 26, 2021

No, everything is covered there. So for the periodic audits after 26th May 2021, you need to have in place the following elements for the MDR (point 17.-4 in the document that you referred to):

a) Registration of economic operators and of devices (see Art. 31 MDR and Art. 29 MDR)
b) Post market surveillance (PMS) (see Art. 83-86, 92 MDR including Annex III but without the PMS having to be an integral part of the QMS)
c) Market surveillance (see Art. 93 – 100 MDR, but device standards to be met = Directives)
d) Vigilance (see Art- 87-92 MDR)

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May 25, 2021

May 26, 2021