MDD requirement and compliance to CE Marking allows access to the EU market (according to Article 14 MDD 93/42/EEC as amended by the 2007/47/EC and Article 10 IVDD 98/79/EC)..

CE Certification only enables penetration to the European market and not to other global markets such as Middle East and African countries.

Due to the high standards and popularity of CE Marked Medical Devices the non-EU countries request a Free Sale Certificate from the manufacturer to demonstrate the medical device meets MDD requirements. In short, with Free Sale Certificate (FSC) manufacturer can penetrate the market of the relevant country and be freely sold to the public presuming all local requirements are also met.

QualiMEDtech help non-European manufacturers for FSC, if you

  • Appoint us as your European Authorized Representative
  • Submit the below documents
    • Medical Device Information
    • CE Certificate
    • DOC
    • Legal Manufacturer contact Information
    • Notified Body contact Information

Process flow

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