CE certification of medical devices by DQS Medizinprodukte GmbH (MED) enables you to further exploit potentials in developed markets ,and to enter new national as well as international markets with the respective required tests and compliant products. Risks and liabilities in your chosen markets are also mitigated.
Before you place a medical device on the European market or put it into service, your medical devices must be CE marked. Medical device in this sense is an object or a substance used for medical, therapeutic or diagnostic purposes for human beings, where the main intended effect is primarily not pharmacological, metabolic or immunological, but physical or physio-chemical, in contrast to pharmaceuticals. The CE mark is not a quality mark and is not intended for consumers. It is a legally binding statement by the manufacturer that their product meets all the requirements of the Medical Device Regulation (EU) 2017/745.
The certification process for MDR (EU) 2017 / 745 in detail:
First, we need a description of your certification project. This includes information about your company as well as about your products; essential are especially the purpose and the classification of your products. We request all this information from you in the form of our so-called "basic data" in a special format.
2. COST ESTIMATE AND APPLICATION FOR CERTIFICATION
Based on the information and documents you submit, we will provide you with a cost estimate specifying the estimated expenses for the audit and product file review. Together with the cost estimate you will receive the application documents.
We may need more information from you, or the information in the basic data needs 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 with the receipt of the application your conformity assessment procedure according to Regulation (EU) 2017/745 starts and the application alone does not guarantee a certification. Please also note our general terms and conditions regarding our notification obligations.
Your application documents will be reviewed in a documented manner. If there are any changes to the estimated expenses during the application review, 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 application (form) MDR by the notified body.
Detailed planning of the customer's procedure
Based on the information and documents submitted by you, we plan the conformity assessment procedure. This consists of the assessment and auditing of the QM system (system level) and review of technical documentation (product level).
Product file review and readiness assessment
The first step is the required product file reviews. The results are summarized in reports and used in the further course of the conformity assessment procedure. You will receive these reports.
Please note: In the case of product file reviews, you have several attempts at rectification, but in the case of new applications, we must terminate the conformity assessment procedure after the third unsuccessful rectification. This also results in reporting obligations for us according to Regulation (EU) 2017/745.
Next, the readiness assessment (stage 1) takes place. Here, your QMS documentation and your 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 also used in the further course of the conformity assessment procedure. Of course, you will also receive this report.
Updating the planning, supplementing audit objectives
We combine the results of the product file audits and the readiness assessment and evaluate them to determine whether the system assessment that follows in the next step can be carried out as planned or whether adjustments (for example, to the audit content) need to be made.
Please note: Here, too, we must terminate your conformity assessment procedure if you are still unable to demonstrate sufficient readiness for the following system assessment in the third attempt. In this case, too, this results in notification obligations for us in accordance with Regulation (EU) 2017/745.
The system assessment (stage 2) always takes place on your premises, as you are familiar with from other certification programs. However, there are definitely differences in terms of content, such as verification of the information in the product files on site, if necessary with appropriate samples.
System assessment (reporting)
The results of the system assessment are also summarized in the form of a report. If nonconformities were found in the audit, these are also included. The report (system assessment) ends with the assessor's certification recommendation.
4. CERTIFICATION DECISION
Certification Decision Making
Once the system assessment is completed, the review and assessment is carried out by our certification decision makers. In this process, the certification recommendation of the assessor 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 specialist certification and comply with our notification obligation in accordance with Regulation (EU) 2017/745.
DQS Medizinprodukte GmbH stands for high quality, which we ensure through extensive internal quality assurance measures. As a final instance, we have installed a certification board for review. This ensures that certification decisions are made correctly and actions are taken where necessary.
Congratulations, your certification has been granted. You will now receive your certificate and the report of your system assessment.
A product approval by DQS MED enables you to further exploit potentials in developed markets, and to enter new national as well as international markets with the respective required certification and regulation-compliant products. The approvals give you a clear competitive advantage. You also mitigate risks and liability obligations in your chosen markets.