CE Marking Back

 

Need CE mark for your medical device? Contact us:

We can make gap analysis of the file of  your medical devices in order to pass conformity assesment.

We can make gap analysis of your management system according  to ISO 13485.


What you should know:

 

Classification of Medical Devices

The classification serves to determine which conformity assessment procedure to apply and whether or not a notified body is to be involved.

 

The manufacturer of medical device assigns class for his product. Main criteria for classification are duration of contact with the body, degree of invasiveness and vulnerability of parts of the body in which the medical device is used.

 

Devices shall be divided into Classes I, IIa, IIb and III. The classification is essentially based on potential hazards to the use and possible failure of the devise. The highest risk class (III) includes products which come into contact with the central nervous system, the heart or the central circulatory system as well as medical devices incorporating medicines. Classification criteria you can find in Annex IX to the Directive. Recommendations for classification of medical devices are submitted in MED DEV 2.4/1 Rev9.

 

Conformity Assessment

Directive provides partial responsibility to the manufacturers for the conformity of medical devices to the requirements of the Directive.

For example, the manufacturer itself assesses and declares conformity to the Directive if its device is of class I, non sterile and without measuring function.

 

The Role of the Notified Bodies

The manufacturer may freely choose any Notified Body of the European Union. 

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