CE Marking for Medical Devices

CE Marking for Medical Device Market Access Europe

Europe

CE Certification Strategy

To sell medical devices in the European Union, you must apply CE Marking for your product. CE Marking indicates that your medical device complies with the applicable EU Regulations. The regulation outline the safety and performance requirements for medical devices in the EU.

Qserve can help you with the European CE approval process for medical devices and IVD products.

 

 

CE Marking process: 

  • Determine which EU directive applies
  • Determine the classification
  • Determine Conformity Assessment Procedure
  • Notified Body selection
  • Prepare a Technical file or Design dossier
  • Prepare a Clinical Evaluation Report
  • Implement or update the Quality Management System
  • Select a European Authorized Representative, if required.
  • Appoint a Person Responsible for Regulatory Compliance
  • Internal audit for your QMS and Technical file
  • Submit to Notified Body 
  • Declare Conformity of Medical Device
  • Collect data (PMS, PMCF)

Do you plan to obtain market access for your medical device in Europe?
Qserve supports you with the CE approval process.

Contact us

About Qserve Group

Qserve has been supporting Medical Device and IVD companies with regulatory compliance and market access since 1998. We have offices in Europe, the US, and China offering a wide range of compliance, quality and clinical services. 

Our customers value us for our practical approach, our international focus and or broad and specific expertise. Qserve is the one-stop partner for all compliance projects with the final goal: getting their product on the international market. 

Support for experienced or starting companies

Multinationals

Challenges with Notified Body, CAPA system, resources for global registration, maintenance of technical files, preparation of Clinical Evaluation Reports, PRRC, PMCF, and Risk Management.

 

SME's

Lack of resources and hands-on expertise for further product development and network for compliance with international regulations.

 

Startups

Challenges with regulatory requirements and in need of a partner that can assist with all compliance issues, from strategy to market approval.

How can we help you? Contact us