Medical Devices in the EU: CE Mark and Medical Device Directive 93/42/EEC Webinar
This webinar will acquaint the participants on the steps required to obtain CE Mark, latest amendments to the Medical Devices Directive and the compliance requirements.
MDD 93/42/EEC of the European Union (EU) (also known as the Medical Devices Directive - MDD) details the Essential Requirements manufacturers and importers must meet to apply the CE mark and legally market or sell their devices in the EU. Because of the many types of devices covered by the MDD, the specific requirements depend on the classification and intended use of the device. However, in most cases, the use of an EU Notified Body is required to assess compliance with the Directive before the CE mark can be applied to a device.
Why Should you Attend:
Today, all medical devices sold in the EU must have the CE Mark affixed to demonstrate compliance to this directive. If your device falls within the scope of the Medical Devices Directive, then you must meet the essential requirements of that law.
Objectives of the Presentation:
The chief objectives of the presentation are to train the participants on:
- Identifying the steps required to obtain CE Mark and meeting compliance expectations.
- The latest changes to the directive and impact on medical device manufacturers.
- Understanding how to apply and use the Conformity Assessment Procedure.
- How to classify your medical device correctly.
- How to develop and use the Technical File or Design Dossier correctly.
- How to apply the Declaration of Conformity and why this is critical for success.
- How ISO 13485 fits in with this process as a device company.
- Understanding the expectations for the Essential Requirements and the Certification Process.
- How is the Authorized Representative involved and why and the ramifications of not meeting the requirements for CE Mark and 93/42/EEC for your company.