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When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019?

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YellowQCPro

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#1
#1
Hi! Thank you in advance for reading this question.
When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019?
How long after the publication date (in this care 10DEC19) do MedDev manufacturers have to implement revisions?
 
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Ronen E

Ronen E

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#2
#2
YellowQCPro said:
Hi! Thank you in advance for reading this question.
When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019?
How long after the publication date (in this care 10DEC19) do MedDev manufacturers have to implement revisions?
Click to expand...
(Emphasis added)

Never.
At most, ISO 14971:2019 will be harmonized as EN ISO 14971:20xx, and even then it'll still be voluntary under the MDR.
Generally speaking, ISO allocates 3 years for transition, so in this case by the end of 2022 the new revision will be considered as having fully replaced the previous one. But that doesn't normally automatically set a hard requirement either.
 
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