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).
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Directive |
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.
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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.
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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.
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EC-REP
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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.
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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.
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ISO 13485 |
Step 8 |
All Class I devices must be registered with the Competent Authority where your EC REP is based.
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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.
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Declaration of Conformity |
Step 10 |
You may now affix the CE Marking.
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CE Marking
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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.