CE certification of medical devices by MedDeviceCorp allows you to further exploit potentials in developed markets, and to enter new national and international markets with the respective required tests and compliant products. Risks and liabilities in the chosen markets are also mitigated.

Who owns the CE certification for medical devices?

Before placing a medical device on the European market or putting it into service, your medical devices must bear the CE marking. In this sense, a medical device is an object or a substance that is used for medical, therapeutic or diagnostic purposes for human beings and whose main effect is not pharmacological, metabolic or immunological, but physical or physiochemical, unlike products pharmacists.

The CE mark is not a quality mark and is not intended for consumers. It is a legally binding declaration from the manufacturer that their product meets all the requirements of Regulation (EU) 2017/745 on medical devices.

What is the CE certification process for medical devices?

First of all, we need a description of your certification project. This includes information about your company, as well as your products; the purpose and classification of its products are essential above all. We ask you for all this information in the form of our so-called "basic data" in a special format.

1. BUDGET AND CERTIFICATION REQUEST

Based on the information and documents you submit, we will provide you with a cost estimate specifying the expected costs for the audit and product dossier review. Together with the cost estimate, you will receive the application documents.

Application:We may need more information from you, or the Basic Data information may need to be more specific. If you wish to accept the cost estimate, simply sign and return the completed application documents to us.

Please note: Already in the application we point out that upon receipt of the application, your conformity assessment procedure begins according to Regulation (EU) 2017/745 and that the application alone does not guarantee a certification. Please also note our general conditions on our notification obligations.

Application review:Your application documents will be reviewed in a documented manner. If changes in the estimated costs occur during the review of the application, you will receive an updated offer from us. An effective contract for the conformity assessment procedure according to Regulation (EU) 2017/745 is concluded only with the acceptance of the formal request (form) MDR by the notified body.

1. AUDIT

Detailed client procedure planning

Based on the information and documents submitted by you, we plan the conformity assessment procedure. This consists of the evaluation and audit of the quality management system (system level) and the review of the technical documentation (product level).

Product dossier review and readiness assessment

The first step is the product dossier review. The results are summarized in reports and used in the further course of the conformity assessment procedure. You will receive these reports.

Please note: For product dossier reviews, you have several rectification attempts, but for new applications, we must terminate the conformity assessment procedure after the third rectification. unsuccessful. This also gives rise to notification obligations for us under Regulation (EU) 2017/745.

Next, the evaluation of the readiness (phase 1) takes place. Here the documentation of your QMS and its described processes are reviewed. The following question needs to be answered: Is your system ready for the next step?

The results of the readiness assessment are summarized in the form of a report and are also used in the further course of the conformity assessment procedure. Of course, you will also receive this report.

Planning update, complementing audit objectives

We combine the results of the product dossier audits and the readiness assessment and assess them to determine whether the system assessment that follows in the next step can be carried out carried out as planned or if adjustments are necessary (for example, in the content of the audit).

Please note that in this case, too, we must terminate the conformity assessment procedure if you still cannot demonstrate sufficient readiness for the next system assessment on the third attempt. Also in this case, this gives rise to notification obligations for us in accordance with Regulation (EU) 2017/745.

System Assessment System

Assessment (Phase 2) always takes place at your facility, as you know from other certification programs. However, there are definitely differences in terms of content, such as checking the information in the product files on the site, if necessary with appropriate samples.

System evaluation (report)

The results of the system evaluation are also summarized in the form of a report. If non-compliances have been detected in the audit, these are also included. The report (system assessment) ends with the evaluator's certification recommendation.

1. CERTIFICATION DECISION

Once the system assessment is complete, our certifiers carry out the review and evaluation. In this process, the evaluator's certification recommendation is confirmed or rejected. If necessary, follow-up work is requested if questions remain unanswered in the report. In this case, we will contact you.

Please note: In the case of new applications, we must complete the conformity assessment procedure negatively after the third negative specialized certification and fulfill our notification obligation according to Regulation (EU) 2017/745.

MedDeviceCorp stands for high quality, which we guarantee through extensive in-house quality assurance measures. As a last resort, we have installed a certification board for your review. This ensures that certification decisions are made correctly and that action is taken when necessary.

Certificate Issuance

Congratulations, your certification has been granted. You will now receive your certificate and your system assessment report.

What are the advantages of CE certification for medical devices?

The approval of a product by MedDeviceCorpallows you to further exploit the potential in developed markets and enter new national and international markets with the respective required certification and products that comply with regulations. Approvals give you a clear competitive advantage. They also mitigate risks and liability obligations in the chosen markets.