YOUR PATH TO CE MARKING (IVDR)

Once the contract is signed, we can start our conformity assessment activities. These vary significantly depending on the product and conformity assessment route taken.

 

WHAT ACTIVITIES ARE CARRIED OUT BY QMD SERVICES?

  1. PREPARING FOR CERTIFICATION

    Initial CE certification can be a lenghty process. Experience shows that an average process might take a significant number of months. The most important factor influencing the certification time is your preparedness as applicant.

    Before you apply for certification you need to have a fully implemented Quality Management System according to the requirements of the regulation and complete technical documentation in place for each product. You also need to have a clear decision on your conformity assessment route, the intended purpose and risk class of the devices as well as the applicable codes. 

  2. PRE-APPLICATION

    Please get in contact with us via our Online Contact Form. Following an initial discussion with our Customer Service Team, you will need to submit us information about your company and products. We will conduct a feasibility check and decide if we can offer you our services.

    Your information provided will determine the required activities to demonstrate conformity. We will review your information and if requested provide you with a non-binding budget estimate for our services.

  3. APPLICATION

    For concluding a service contract we require an application signed by the legal manufacturer or an authorised representative containing all relevant information. Our application form will support you to provide the complete, necessary documents.

    Our QMD Services project leader will review your application and resulting contract for completeness, requesting any additional information required.

  4. PROJECT PLANNING

    QMD will prepare a plan for the conformity assessment activities including technical documentation sampling for initial and on-going surveillance assessments.

  5. TECHNICAL DOCUMENTATION

    QMD technical experts with the relevant product expertise will be assigned to conduct your product review. Our experts will review the content of your technical documentation, including any additional test reports or clinical data that provide evidence for conformity to the Regulation. We will require actions and documentation if non-conformities are identified. Your product(s) may also be subject to additional assessment, testing by EU certified Laboratories, or scientific opinion from an expert panel. 

  6. QMS AUDIT

    A Quality Management System (QMS) Auditor will be assigned to assess your system to the QMS requirements of the Regulation through a two-stage audit: A system review (stage 1) will review the completeness of your QMS, and the QMS Audit Stage 2 will review the effective implementation and its compliance to the Regulation.

  7. DECISION TAKING

    Following successful assessments of your Quality Management System and technical documentation, our technical experts then make a positive recommendation to a final, independent reviewer who looks at everything and approves the CE Mark.

  8. ISSUING THE CERTIFICATE

    Once approved, your certificates will be issued electronically to your organization.

  9. MAINTENANCE OF CE CERTIFICATION

    Technical Documentation sampling, Maintenance (e.g. changes) and surveillance activities continue during the life of the certificate after which recertification takes place.