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I have a question on MDR implementation: Is it confirmed that custom-made devices are exempt from CE marking? According to MDR art.20 par.1, and art.52 par.8, I believe that custom-made devices are exempt from CE marking. Are there any conflicting interpretations or guidelines? Thanks. Marked as spam
 Posted by Asked on August 7, 2018 8:49 am
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Andrew Pacey
Think you find it is the same as with the MDD. You can use a custom-made device for a named patient and clinicals but it still has to meet the Annex I ER. You can not just print something in your office, wash it in ethanol and stick it in to the patient without the local approvals. Not saying it does not happen,,,, Marked as spam
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Antonia Trevisan
ok, it still has to meet the Annex I ER of course. Marked as spam
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Robert Packard
Correct answer from Roland.:) He’s an experience NB auditor. Marked as spam
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Robert Packard
For the MDR, there is also an Annex specific to custom-made devices: Annex XIII. Although you are not required to place the “CE” on your product or label, as stated in Article 20, you are required to have a Declaration in accordance with Annex I. You are also required to undergo a conformity assessment procedure for Class III implantable devices in accordance with Annex IX, Chapter 1 or Annex XI, Part A (i.e., full quality system). Another consideration is whether the device is actually “custom-made.” Many orthopedic devices are patient-matched, and they are not considered custom-made. Rob Packard Marked as spam
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