Investigational Medical Device Dossier

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D2. Investigational Medical Device Dossier (IMDD) - CCMO

https://english.ccmo.nl/investigators/clinical-investigations-with-medical-devices/standard-research-file-medical-devices/d-product-information/d2-investigational-medical-device-dossier-imdd

The Investigational Medical Device Dossier (IMDD) specifies the content of the documentation on non CE-marked medical devices in clinical investigations that you are …

Investigational Device Exemption (IDE) | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to …

IDE Responsibilities | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-responsibilities

Promotion of Investigational Devices (§812.7) Under §812.7, a sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator cannot:

IDE Approval Process | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process

In order to conduct a significant risk device study, a sponsor must: submit a complete IDE application ( §812.20) to FDA for review and obtain FDA approval of the …

New version Investigational Medical Device Dossier (IMDD

https://english.ccmo.nl/latest/news/2020/12/15/new-version-investigational-medical-device-dossier-imdd-template-available

A new version of the Investigational Medical Device Dossier (IMDD) template is available. This version is an update of the previous version from September …

Investigational Medical Devices - Hopkins Medicine

https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/devices.html

Medical devices include, among other things, surgical laser, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Medical devices …

IDE Regulations | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-regulations

Regulations pertaining to the Investigational Device Exemptions (IDE) 21 CFR 812 - Investigational Device Exemptions; 21 CFR 50 - Protection of Human Subjects

D1. Investigator’s Brochure (IB) | Investigators | The Central ...

https://english.ccmo.nl/investigators/clinical-investigations-with-medical-devices/standard-research-file-medical-devices/d-product-information/d1-investigator%E2%80%99s-brochure-ib

An Investigator's Brochure (IB) is a summary of the clinical and pre-clinical data on the investigational device(s) that are relevant to the clinical investigation of the …

Applications for Medical Device Investigational Testing …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance/guidance-document.html

The terms “investigational medical device” and “investigational device” are used interchangeably. Return to footnote 7 referrer. Footnote 8. Although not defined in the Medical Devices …

Trial documentation and identification of documents …

https://www.aemps.gob.es/en/investigacionClinica/medicamentos/docs/annex1-Ins-AEMPS-EC.pdf

Medical Devices. 3. Investigational medicinal product dossier quality part (IMPD Q), where applicable. Name: <<IMPD_Q medicinal product name_ yyyy_mm_dd>> The part with …

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