MDR: Are custom-made devices exempt from CE marking? - Medical Devices Group

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Antonia Trevisan

regulatory engineer presso Lima Corporate

August 2018

MDR: Are custom-made devices exempt from CE marking?

< 1 min reading time

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.

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Posted by Antonia Trevisan

Asked on August 7, 2018 8:49 am

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	Private answer 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 1 like Report spam
	Private answer Antonia Trevisan ok, it still has to meet the Annex I ER of course. thanks so much Marked as spam like Report spam
	Private answer Custom-made devices are far from exempt from the MDD, in fact there is a specific Annex (VIII) which covers the requirements. Marked as spam 2 likes Report spam
	Private answer Robert Packard Correct answer from Roland.:) He’s an experience NB auditor. Marked as spam like Report spam
	Private answer 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 https://medicaldeviceacademy.com rob@13485cert.com Marked as spam 1 like Report spam

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