MDCG_2024-11_Guidance on qualification of in vitro diagnostic medical devices

VIP免费

3.0 冒牌货 2026-01-09 3 269.84KB 13 页 80质量币

侵权投诉

Page 1 of 13

Medical Devices

Medical Device Coordination Group Document MDCG 2024-11

MDCG 2024-11

Guidance on qualification of in vitro diagnostic

medical devices

October 2024

This document has been endorsed by the Medical Device Coordination Group(MDCG)

established by Article 103 of Regulation(EU)2017/745.The MDCG is composed of

representatives of all Member States and it is chaired by a representative of the

European Commission.

The document is not a European Commission document and it cannot be regarded as

reflecting the official position of the European Commission.Any views expressed in

this document are not legally binding and only the Court of Justice of the European

Union can give binding interpretations of Union law.

Page 2 of 13

Medical Devices

Medical Device Coordination Group Document

MDCG 2024-11

Table of contents

Introduction ......................................................................................................................................................... 3

1. General principles of qualification .......................................................................................................

1.1. Definition of a medical device and an in vitro diagnostic medical device ( IVD) ............... 3

1.2 Essential characteristics of an IVD .................................................................................................. 4

2. Specific qualification topic ............................................................................................................... 6

2.1. Accessorie ..............................................................................................................................................6

2.2. Specimen receptacles and products used for the collection of specimen ..........................6

2.2.1. Specimen receptacles.................................................................................................................. 6

2.2.2. Products used for the collection of specimens ................................................................... 7

2.3. Devices where no specimen is involved ....................................................................................... 7

2.4. Products for general laboratory use .................................................................................................

2.5. Products for research use only..........................................................................................................9

2.6. Combinations of products placed on the market together ....................................................... 9

2.6.1 IVD kit ............................................................................................................................................. 9

2.6.2 Devices incorporating , as an integral part , a medical device ....................................... 10

2.7. Calibrators and control materials ................................................................................................... 11

2.8. Software ............................................................................................................................................... 12

2.9. Microbiological culture media ....................................................................................................... 12

2.10. Stain ................................................................................................................................................... 12

2.11. Tests intended to be used in manufacturing process control .............................................12

2.12. Tests intended to be used in the context of biological or chemical warfare ............... 13

2.13. Tests to be used in law enforcement ....................................................................................... 13

2.14. Relation with Regulation (EU ) No 528/2012 on biocidal products ...................................13

Page 3 of 13

Medical Devices

Medical Device Coordination Group Document MDCG 2024-11

Introduction

The purpose of this guidance document is to clarify what products fall in scope of Regulation

2017/746 on in vitro diagnostic medical devices (IVDR)-also referred to as 'qualification'as

an in vitro diagnostic medical device(IVD)or an accessory to an IVD.In order to be qualified

as an IVD or an accessory to an IVD,the product must fulfil the definition in Art 2(2)or Art 2(4)

of the IVDR respectively.The qualification depends on the intended purpose as described by

the manufacturer.

The demarcation between the IVDR and Regulation (EU)2017/745 on medical devices(MDR)

is of particular importance because the MDR lays down in its article 1 that it shall not apply to

in vitro diagnostic medical devices (IVDs).

The present guidance document provides non-exhaustive lists of examples of IVDs and

accessories to IVDs.Further detailed examples may be found in the Manual on Borderline and

Classification in the Community Regulatory framework for medical devices.The reader could

also find it useful to consult MDCG 2019-11“Guidance on Qualification and Classification of

Software in Regulation (EU)2017/745-MDR and Regulation (EU)2017/746-IVDR”.Both

documents are published on the European Commission website¹.

The examples provided are indicative and the qualification of specific products should be

considered on a case-by-case basis by each manufacturer based on their intended purpose.

Thus,products detecting or measuring the same analyte could be qualified differently,

depending on the intended purposes as assigned by each manufacturer.

1.General principles of qualification

In deciding on whether a product falls within the scope of the IVDR,the primary considerations

are the provisions and definitions set out in Articles 1 and 2 of the IVDR.

1.1.Definitions of a medical device and an in vitro diagnostic medical device(IVD)

Article 2 (2)of the IVDR defines an IVD as:

"in vitro diagnostic medical device’means any medical device which is a reagent,reagent

product,calibrator,control material,kit,instrument,apparatus,piece of equipment,software

or system,whether used alone or in combination,intended by the manufacturer to be used in

vitro for the examination of specimens, including blood

and tissue donations,derived from the human body,solely or principally for the purpose of

providing information on one or more of the following:

(a)concerning a physiological or pathological process or state;

(b)concerning congenital physical or mental impairments;

(c)concerning the predisposition to a medical condition or a disease;

(d)to determine the safety and compatibility with potential recipients;

(e)to predict treatment response or reactions;

(f)to define or monitoring therapeutic measures.

See Medical Device Coordination Group guidance documents here: https://health.ec.europa.eu/medical-devices-sector/new-

regulations/guidance-mdcg-endorsed-documents-and-other-guidance en#sec1

文档加载中……请稍候！
如果长时间未打开，您也可以点击刷新试试。

下载文档到电脑，查找使用更方便

立即下载 VIP免费下载

标签： #MDCG

摘要：

Page1of13MedicalDevicesMedicalDeviceCoordinationGroupDocumentMDCG2024-11MDCG2024-11GuidanceonqualificationofinvitrodiagnosticmedicaldevicesOctober2024ThisdocumenthasbeenendorsedbytheMedicalDeviceCoordinationGroup(MDCG)establishedbyArticle103ofRegulation(EU)2017/745.TheMDCGiscomposedofrepresentatives...

展开>> 收起<<

MDCG_2024-11_Guidance on qualification of in vitro diagnostic medical devices.pdf

共13页,预览13页

还剩页未读，继续阅读

声明：如果您的权利被侵害，请联系我们的进行举报。

MDCG_2024-11_Guidance on qualification of in vitro diagnostic medical devices

相关推荐

相关内容

热门标签

举报选择: