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Europe Ce Marking Process for Medical Devices

 

Step 1

Determine which EU Medical Device Directive applies to your device:

93/42/EEC – Medical Devices Directive (MDD) or 90/385/EEC - Active Implantable Medical Devices Directive (AIMDD).

 

Directive

Polmed-25

Step 2

Determine Classification of your device using Annex IX of the Medical Devices Directive (MDD):

Class I (non-sterile, non-measuring),Class I (sterile, measuring),

Class IIa,Class IIb or Class III/AIMD.

* Active implantable medical devices are subject to the same regulatory requirements as Class III devices

Classification

Step 3

For all devices except Class I (non-sterile, non-measuring), implement Quality Management System(QMS) in accordance with Annex II or Annex V of the MDD.

 

 

Quality Management System

Step 4

For Class III/AIMD devices, prepare a Design Dossier*. For all other devices, prepare a CE Technical File that provides detailed information on your medical device demonstrating compliance with MDD 93/42/EEC. 

* Class III / AIMD devices will likely required clinical study data. Existing clinical data may be acceptable. Clinical trials in Europe must be pre-approved by a European Competent Authority.

 

 

Technical File

Step 5

Appoint an Authorized Representative (EC Rep) located in Europe.

Place EC REP name and address on Instructions for Use and, packaging.

 

EC-REP

 Polmed-11

Step 6

For all devices except Class I (non-sterile, non-measuring), your QMS and Technical File or Design Dossier must be audited by a Notified Body, a third party accredited by European authorities to audit medical device companies and products.

 

Notified Body

Step 7

For all devices except Class I (non-sterile, non-measuring), you will be issued a European CE Marking Certificate for your device and an ISO 13485certificate for your facility following successful completion of your Notified Body audit.

 

ISO 13485

Step 8

All Class I devices must be registered with the Competent Authority where your EC REP is based.

 

Competent Authority

Step 9

Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable Directive.

 

 

Declaration

of Conformity

Step 10

You may now affix the CE Marking.

 

CE Marking

 Polmed-26

 

 

Polmed-8 

 

In order to commercialize medical and IVD devices in the European Union,a CE Mark certificate is needed.

This certification verifies that a device meets all regulatory requirements of the Medical Devices Directive (MDD), In Vitro Diagnostic Device

Directive (IVDD) or Active Implantable Medical Device Directive (AIMD) as they apply to your product. 

 

 

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