PREPARING FOR CERTIFICATION
Initial CE certification can be a lengthy process. Our experience working with many first-time applicants is that it can take a significant number of months to complete the certification process. The most important factor influencing the certification time is your preparedness as an applicant.
The first preparation activity is to establish an operational quality management system (QMS) that complies with the regulation. It is within an established QMS that device development activities and the generation of device technical files should occur. Secondly, a technical file that meets the requirements of the IVDR must then be completed and submitted for assessment.
PRE-APPLICATION
Please get in contact with us via our online contact form. Initially, we will conduct a free feasibility check to confirm if we can offer you our services and we will reach out to you for an initial discussion with our Client Team.
To complete the form, you will need to have made a decision on your conformity assessment route, the intended purpose, risk class, and applicable IVDR codes.
We will request that you submit substantial detailed information about your company and device(s). We will then do a detailed assessment of your device(s) assigned codes, and review its classification and risk. A quotation will be generated so you can plan a budget. The quotation is non-binding and is subject to change depending on when the service is initiated. This step is essential to ensure both parties can move to a formal application knowing that service provision is available and to avoid erroneous notifications in EUDAMED.
APPLICATION
A formal application for conformity assessment is required under the regulation. We initiate this process on receipt of a signed copy of our service contract.
Over the application process we will do a review of your QMS structure and documentation. We will initiate internal planning to structure your conformity assessment service, including site audits. A named project leader will be assigned to support you through the application and conformity assessment stages.
At the end of the phase, we will countersign the service contract. You will then have a formal contract with us as your Notified Body for the device(s) covered in the application.
COMPLETENESS CHECK AND PROJECT PLANNING
Once we have concluded a service contract you will be asked to upload your technical documentation. Your assigned project leader will review the technical file to ensure everything is in place to start conformity assessment services. If complete, we will prepare a final plan for the conformity assessment activities including technical documentation sampling for initial and on-going surveillance assessments. We will send you a date confirming the start of the service and will contact you to plan the audit schedule.
START OF CONFORMITY ASSESSMENT
For QMD Services to be able to issue a date for the start of conformity assessment we first check that you provided a complete set of technical documentation. Conformity assessment services are offered on a first-come, first-served basis, depending on the client’s readiness for certification.
TECHNICAL DOCUMENTATION ASSESSMENT
Our experienced technical experts will conduct your product review. We will review the content of your technical documentation, including any additional test reports or clinical data that are provided as 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 assessments, testing by EU certified laboratories, or a scientific opinion from an expert panel. For devices that require such third party review, additional time will be needed to complete conformity assessment.
QMS AUDIT
An auditor will be assigned to assess your QMS and will determine if it meets the requirements of the Regulation through a two-stage audit. Audits for initial device certification only start after the first round of technical documentation review is concluded. For stage 1, we perform a desk audit to assess your QMS system to ensure that it contains all processes for compliance to the IVDR. For stage 2 we verify that the QMS conforms to the Regulation at your site(s).
DECISION TAKING
Following successful assessments of your QMS and technical documentation, our technical experts then make a positive recommendation to a final, independent reviewer who confirms our work and approves the CE Mark.
ISSUING THE CERTIFICATE
Once approved, your certificates will be issued electronically to your organisation.
MAINTENANCE OF CE CERTIFICATION
Technical documentation sampling, maintenance, and surveillance activities continue during the life of the certificate. We will work with you on a schedule over the device(s) lifecycle to keep abreast of what data we need to review and at which intervals. All certificates have a maximum five-year span after which re-certification takes place and the entire processes starts anew.
