EMC Test for Medical Devices

The Importance of Medical Devices in Our Lives

Nowadays, the medical devices used in medicine are very important. Ultrasound, magnetic resonance, dentist chair, radiological methods, such as the diseases formed in our body to be seen in the finest detail is possible to see. There are EMC tests that must be applied to medical devices used in medicine, the accuracy and construction of these tests is very important. In the case of improper application of parts, such as standard, test coverage, human health is at great risk when any problem occurs.

The Importance of CE Marking for Medical Devices

The CE marking is of great importance for the medical devices to easily move around Europe. The EMC tests of these types of medical products and the CE Marking carry important factors such as health, safety, environment and consumer protection.

To get CE Mark on Medical Devices

Ege Test Center team of experts is implementing in conjunction with the first of medical devices accredited scope of the EMC Tests and reporting stage in your side apply.medical your device accredited in scope to get the Ege Test Center could e-mail address or You can reach us by filling in the form.

European CE Marking Strategy for Medical Devices

To sell medical devices in the European Union (EU), you must obtain or apply CE Marking for your product. CE Marking indicates a product’s compliance with the applicable EU regulations and enables the commercialization of your products in 32 European countries. As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation.

How to obtain CE marking for your medical device

CE is not a quality mark, but compliance with EU Directives requires you to meet specific standards of performance, quality, safety, and efficacy for your product type. We have a detailed chart explaining the current The basic process follows these steps:

  1. Determine which EU Directive applies to your device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC) or Active Implantable Medical Devices Directive (90/385/EEC)
  2. Determine the classification of your device.
  3. Implement a Quality Management System, if applicable to your device. Most companies use ISO 13485 to meet the requirements.
  4. Prepare a CE Marking Technical File or a Design Dossier
  5. Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe.
  6. Have your QMS and Technical File/Design Dossier audited by a Notified Body, unless your device is Class I, is not sterile and has no measuring function.
  7. Obtain CE Marking and ISO 13485 certificates from your Notified Body.
  8. Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive.

For Communication and Apply

For detailed information and communication, you can send an email to us or you can fill the form by clicking this Online Application link.