MEDDEV 2.1-3 : REV 3 : 2015
Current
The latest, up-to-date edition.
BORDERLINE PRODUCTS, DRUG-DELIVERY PRODUCTS AND MEDICAL DEVICES INCORPORATING, AS INTEGRAL PART, AN ANCILLARY MEDICINAL SUBSTANCE OR AN ANCILLARY HUMAN BLOOD DERIVATIVE
Hardcopy
English
05-18-2015
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SECTION A. BORDERLINE MEDICAL DEVICES /MEDICINAL
PRODUCTS
SECTION B. DRUG-DELIVERY PRODUCTS AND MEDICAL
DEVICES INCORPORATING AS AN INTEGRAL PART,
AN ANCILLARY MEDICINAL SUBSTANCE OR AN
ANCILLARY HUMAN BLOOD DERIVATIVE
Gives non-exhaustive lists of examples of medical devices, accessories to medical devices and medicinal products.
| DevelopmentNote |
Available for free download. (01/2017)
|
| DocumentType |
Miscellaneous Product
|
| Pages |
22
|
| PublisherName |
European Union
|
| Status |
Current
|
| UNE-EN ISO 12417-1:2016 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| ISO/TR 12417-2:2017 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information |
| AAMI ISO 12417-1 : 2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| MEDDEV 2.7-2 : REV 2 | GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 90/385/EEC AND 93/42/EC |
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