Products not within the MDR grace period

Roland chung

Trusted Information Resource
#1
Hi everyone,

The following products may not be included in the MDR grace period, are there any others?
- products without an intended medical purpose
- software is not qualified as a medical device under MDD but a medical device under MDR
- Class I devices under MDD which continue to be Class I under MDR (no involvement of notified body)

best regards,
Roland
 
Last edited:
Elsmar Forum Sponsor

KShaw

Starting to get Involved
#2
Hi Roland,

Might not be 100% relevant for this list, but Article 12 MDD products will technically need to transition to Article 22 MDR unless they are sterilised and covered by a valid certificate.

Otherwise, agreed with all the rest!

Best wishes,
Kenneth
 
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