Name: MEDDEV 2.1-3 : REV 3 : 2015
Brand: EU

BORDERLINE PRODUCTS, DRUG-DELIVERY PRODUCTS AND MEDICAL DEVICES INCORPORATING, AS INTEGRAL PART, AN ANCILLARY MEDICINAL SUBSTANCE OR AN ANCILLARY HUMAN BLOOD DERIVATIVE

Available format(s)

Hardcopy

Language(s)

English

Published date

05-18-2015

Publisher

European Union

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