10 Steps to
SUCCESS
Achive a CE-Mark for your device through conformity assessment with QMD Services:
A lean process from contact to certification.
1
Initial CE certification can be a complex and multifaceted process. The overall duration of the certification process largely depends on the manufacturer’s level of preparedness, quality and completeness of the technical documentation submitted for assessment. Where the review identifies deficiencies, requests for clarification, corrective actions, or the need for additional supporting evidence, further assessment cycles may be required before certification can be granted. As a result, the certification timeline may be extended beyond the initial estimate.
The first step for a manufacturer preparing for CE certification is to establish, implement and maintain a Quality Management System (QMS) that complies with the applicable regulatory requirements – either Regulation (EU) 2017/745 (MDR) for medical devices or Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices. The QMS provides the framework for device design, development and production activities and the creation of the required technical documentation.
2
Before proceeding, please check our scope of designation under the MDR and IVDR in the NANDO database, as we are only authorised to perform conformity assessment for devices that fall within our designated scope.
Please contact us using our online information form. Based on the information provided, we will perform a free feasibility check to confirm whether we can offer certification services. A member of our Client Team will contact you to arrange an initial discussion.
To complete the form, you should already have determined your conformity assessment route, intended purpose, device classification (risk class), and applicable MDR/IVDR codes. This information will allow us to provide an indicative budget estimate for your project.
If you decide to move on to the pre-application process, we will request additional information about your company and device(s). We will review the classification and applicable MDR/IVDR codes assigned to your device(s). Following this review, we will provide a formal quotation for the project.
This step helps ensure that both parties can move forward to a formal application with confidence that the required services can be provided. It also helps avoid unnecessary notifications in EUDAMED should an application later be withdrawn.
3
A formal application for conformity assessment is required under the applicable Regulation. This process is initiated upon receipt of a signed copy of our service contract and quotation.
A dedicated Project Leader will be assigned to guide and support you throughout both the application and conformity assessment processes. During the application phase, we will begin initial planning of the conformity assessment activities, including any required on-site audits.
Once the contract has been countersigned by QMD Services, a formal contractual relationship is established, appointing us as your Notified Body for the device(s) covered by the application. As part of the application review, we will also evaluate the structure of your Quality Management System (QMS) and the associated supporting documentation to confirm readiness for the conformity assessment process.
4
You will be invited to submit your technical documentation for assessment. Your assigned Product Reviewer will conduct an initial review to verify that the documentation is complete and suitable for the start of conformity assessment activities.
If the documentation is complete, we will confirm the conformity assessment program, including the technical documentation sampling plan covering both the initial certification assessment and subsequent surveillance activities, as applicable.
We will also confirm the start date of the project and work closely with you to schedule the required audits and assessment activities.
5
Conformity assessment services are generally scheduled on a first-come, first-served basis, taking into account each client’s readiness for certification. Where mutually agreed, specific timelines can be established in advance and incorporated into the project plan.
6
Our experienced technical experts will conduct a comprehensive review of your device(s). This assessment includes the evaluation of your technical documentation and any supporting evidence provided to demonstrate conformity with the applicable regulatory requirements, such as test reports, performance and clinical data.
Where deficiencies, gaps, or non-conformities are identified, we will issue questions and findings for your response. To facilitate an efficient review process, manufacturers are expected to provide complete and consolidated responses that address all points raised. In general, a maximum of three rounds of questions and responses will be permitted during the technical documentation assessment.
Depending on the type and classification of the device, additional regulatory review activities may be required. These may include testing by EU Reference Laboratories (EURLs) or consultation with relevant expert panels, where applicable under the MDR or IVDR. For devices subject to such third-party involvement, additional time should be anticipated, as conformity assessment cannot be completed until all required external reviews and opinions have been concluded.
7
An auditor will be assigned to assess your QMS and determine its conformity with the applicable MDR or IVDR requirements through a two-stage audit process. For initial certification, the QMS assessment is conducted in parallel with the technical documentation review to support an efficient conformity assessment process.
Stage 1 consists of a documentation review generally conducted remotely, during which we assess your QMS to verify that all required processes and procedures are established and aligned with the applicable regulatory requirements.
Stage 2 is conducted on your site(s) and focuses on verifying the effective implementation and operation of the QMS. During the audit, our auditors assess whether the documented processes are being applied consistently in practice and whether the QMS is being effectively maintained in accordance with the applicable regulatory requirements.
Any non-conformities identified during the audit process must be addressed through appropriate corrective actions before certification can be granted. Once all identified issues have been satisfactorily resolved and the conformity assessment activities have been successfully completed, the certification decision process will be initiated.
8
Following the successful completion of the QMS and technical documentation assessments, our technical experts will prepare a certification recommendation based on the outcome of the conformity assessment activities.
This recommendation is then submitted to an independent review team, which conducts a final verification of the assessment activities and conclusions to ensure consistency, impartiality, and compliance with regulatory requirements.
Upon successful completion of this independent review, the application is forwarded for the formal certification decision.
9
Once a positive certification decision has been made, the relevant certificate(s) will be issued electronically to your organisation.
10
Following certificate issuance, your organisation enters the surveillance phase, during which technical documentation sampling and surveillance activities continue throughout the validity period of the certificate. We will work closely with you to establish an ongoing assessment schedule, ensuring that the appropriate documentation, post-market data, and other relevant evidence are reviewed at defined intervals throughout the lifecycle of your device(s).
Certificates are valid for a maximum period of five years. Prior to expiry, a recertification assessment must be successfully completed to demonstrate continued conformity and enable the issuance of renewed certification.