Need for notified body?
Before proceeding with the assessment procedure, it is important to establish whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.
In the Directive on Medical Devices, the medical device is classified in accordance with the provisions of Annex IX of the MDD as class I (low risk), class IIa or IIb (medium risk) or class III (high risk). The involvement of a Notified Body is not necessary for medical devices of class I unless they have a measuring function or are placed on the market in a sterile condition.
A Notified Body verifies in most of the cases only the quality management of the manufacturer. For all medical devices belonging to class III, and for medical devices belonging to class IIa and IIb on a representative basis, the design of the medical device and its compliance with the Essential Requirements must be examined by a Notified Body. The Notified Body issues a certificate that indicates, by referring to one of the Annexes II to VI of the MDD, what has been verified.
To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please consult NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive, country or by the Notified Body's number (indicated next to the CE marking) via the NANDO homepage.
III. CLASSIFICATION
class I (low risk) 、class IIa or IIb (medium risk)、class III (high risk)
1 . Non-invasive devices
1.1 . Rule 1
All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies .
1.2 . Rule 2
All non-invasive devices intended for channelling or storing blood, body liquids or tissues , liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class Ila:
— if they may be connected to an active medical device in Class Ila or a higher class ,
— if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues , in all other cases they are in Class I.
1.3 . Rule 3
All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class lib, unless the treatment consists of filtration, centrifugation or exchanges of gas , heat, in which case they are in Class Ila.
1.4 . Rule 4
All non-invasive devices which come into contact with injured skin:
— are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates,
— are in Class lib if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent,
— are in Class Ha in all other cases, including devices principally intended to manage the micro-environment of a wound
Annex IX http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042&from=EN
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提升卡
置顶卡
沉默卡
喧嚣卡
变色卡
千斤顶
显身卡