CE marking / Technical Files

About CE marking

In order to sell a medical device in the EU, the product must be CE marked. The CE marking must be obtained by the responsible manufacturer (i.e., the company whose name is on the product). The regulatory requirements for CE marking can be found in the EU’s Medical Device Directive (which is implemented by each member country’s national legislation). The requirements for CE marking encompass the requirements for the product to be safe and suitable (meet essential requirements), as well as requirements for the responsible manufacturer’s quality management system.

The technical documentation for the product and the quality management system must constantly be updated and reflect the product’s and the company’s current situation.

There are no requirements for the structure of either the technical documentation (i.e. technical file) or the quality management system, but it is necessary to establish a structure that makes it possible to work effectively with the application, implementation and updating of both the documentation and the system. In connection with the CE marking, companies should also consider whether or not they intend to sell the product in markets outside the EU and, in such case, they should establish a structure in the technical documentation and quality management system that makes it possible to fulfill requirements outside the EU.

What Symbioteq can do

Symbioteq helps companies to obtain the CE mark for their medical device products. We have extensive knowledge about general medical device products (Class I, Is, Im, IIa, IIb, III), AIMD and IVD, and can help you identify the appropriate structure and application. We can put together all of the technical documentation, project manage the entire process, or support you with specific data/reports/documents. We can, for example:

  • Perform a review of the essential requirements for products
  • Identify applicable standards
  • Establish and update technical documentation (product documentation, technical file)
  • Develop and implement a quality management system or specific QMS procedures
  • Fix deviations from the audit/inspection
  • Evaluate for biocompatibility ISO 10993
  • Perform risk management according to ISO 14971
  • Assist with compliance with IEC 60601-1 (and collateral/particulate standards)
  • Establish usability according to EN 62366
  • Oversee clinical evaluation
  • Select a Notified Body
  • Manage communication with authorities

 

Symbioteq is your partner for all matters relating to MDD, AIMD, IVDD, ISO 13485, ISO 9001, ISO 14971, IEC 60601, EN 62366, IEC 62304, ISO 10993, QSR (FDA 21 CFR Part 820), and other regulations and standards in medical device industry.