Custom Made Medical Devices

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MDR requirements for custom-made medical devices

https://mdrregulator.com/news/custom-made-medical-devices-mdr

The manufacturer of custom-made devices is obliged to implement the procedure for custom-made devices in accordance with Annex XIII of the Regulation …

Custom-made medical device - Wikipedia

https://en.wikipedia.org/wiki/Custom-made_medical_device

Custom-made medical devices - Therapeutic Goods …

https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/personalised-or-custom-made-medical-devices/custom-made-medical-devices

Manufacturers and sponsors of custom-made medical devices must maintain records relating to the devices they have supplied in Australia for: a minimum of 5 years after the …

Custom Device Exemption | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/custom-device-exemption

Issued by: Center for Devices and Radiological Health The Food and Drug Administration (FDA) has developed this document to provide guidance to industry and FDA staff about …

MDCG 2021-3 Questions and Answers on Custom-Made …

https://health.ec.europa.eu/system/files/2021-03/mdcg_2021-3_en_0.pdf

custom-made device adaptable medical device, or patient-matched medical device be placed on the market as medical devices according to the MDR? In accordance with …

How to place a Custom-made Medical …

https://easymedicaldevice.com/custom-made-device/

‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional …

The regulatory pathway for your custom-made …

https://qbdgroup.com/en/blog/the-regulatory-pathway-for-your-custom-made-medical-device/

Custom-made devices require a Statement (see above, Annex XIII, section 1), but not a Declaration of Conformity; Custom-made devices are not CE marked; Make sure to have a list of all …

Custom made Devices according to EU MDR 2017/745

https://www.qualitymeddev.com/2021/08/20/custom-made-devices/

For implantable Class III custom made devices, the conformity assessment is different and it involves quality management system certification, that could be obtained …

Personalized Medical Devices - Regulatory …

https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-pmd-rp-n58.pdf

Note 1:Medical devices that are patient-matched, adaptable or mass-produced shall not be considered to be custom-made. Note 2: A custom made device is intended for a case …

Personalised medical devices | Therapeutic Goods …

https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/manufacture-specific-types-medical-devices/personalised-medical-devices

Both patient-matched and custom-made medical devices are personalised before they are manufactured. Dental aligners, for example, are a patient-matched medical device that …

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