CE-marking

Medical devices sold within the European Union must be CE-marked. Note well that it is up to the responsible manufacturers to ensure that all the requirements for the CE-mark are fulfilled; it is in no way the buyer’s obligation to verify this. Anyone who wants to sell a product covered by the regulatory framework for medical devices must fulfill all the requirements for the CE-mark. There is a list of essential requirements and further requirements apply depending on the classification of the medical device.

The essential requirements include requirements for both the product and the manufacturing company. Products must be provided with a technical documentation with a specified content and companies must have a systematic way of handling matters regarding risk management and post market surveillance.

Symbioteq provides your company with the support to succeed with the CE-marking of your product in a quick and efficient manner.

We can assist you with:

• Review of the essential requirements for your products
• Establish and update your technical files
• Development and implementation of quality management systems
• Performing internal audits