Approval of medical devices for sale or distribution in the European Economic Area
Legal requirement in the EU economic area
Highlights the competence of your company
Demonstrates compliance with the highest product standards
CE mark provides access to additional markets
New Medical Device Regulation (EU) 2017/745 adopted by the European Parliament
Far-reaching changes for medical device manufacturers
The changes in Regulation (EU) 2017/745 for medical device manufacturers.
The changes to Regulation (EU) 2017/745 for Notified Bodies.
What DQS Medizinprodukte GmbH as a Notified Body can do for you
The certification process according to MDR (EU) 2017/745
In order to be able to offer you our services, we first need a description of your planned certification project as well as some product-related information. Of particular importance are your intended conformity procedure as well as intended purpose and risk classifications of your medical devices.
Please provide us with this information in the form provided for this purpose, the so-called basic data.
After we have checked the information you have submitted, we will send you an initial estimate of the costs involved in the evaluation and certification process, including the costs of the QMS audit and the evaluation of your technical documentation.
Together with the cost estimate you will also receive the application forms.
To accept our offer for certification, please submit the completed application form.
Important note: As stated in the application form, your conformity assessment procedure according to Regulation (EU) 2017/745 starts with the receipt of your completed application form. The application itself is not a guarantee of certification. Please note our reporting obligations, which are set out in our General Terms and Conditions (GTCs).
Upon receipt of your application form, we will review and evaluate the data and information you have submitted. For clarification purposes, it may be necessary for us to ask you to provide additional information and details.
Upon successful completion of the review, your application for certification will be accepted. Should we be forced to reject your application at this point for technical or formal reasons, this will result in notification obligations for us as described in our GTCs.
In the first step, the required assessments of your technical documentation(s) are carried out based on a sampling plan. For this purpose, you will be asked to submit all required documents for evaluation. You will receive the result of each assessment in the form of a final report after the certification decision has been made (see next step).
The second step is the system evaluation of your quality management system. This is carried out in stages using a system analysis (stage 1) based on your QMS documentation and an on-site system assessment (stage 2). The results of the system assessment will also be sent to you in separate reports as soon as the certification decisions have been made in the next step.
Please note that in the course of the assessments, reporting requirements or even terminations of the assessment procedures may occur. Possible triggers as well as the corresponding consequences are described in our GTCs.
The results from the assessments of your technical documentation as well as your system assessment are evaluated by an independent panel of experts, who confirm or reject the assessor's certification recommendation. If there are any questions regarding the content, we will contact you.
The certification decision itself is a multi-stage process with several internal control agencies to ensure that certification decisions are appropriate, and that suitable actions are taken.
In order to maintain your certification, we need to perform our surveillance activities at regular intervals. These consist of annual surveillance audits of your quality management system, assessments of your technical documentation according to a defined sampling plan as well as unannounced audits.
Should there be any changes to your quality management system or your technical documentation within a certification cycle, necessary surveillance activities on our part will be included in your audit cycle.
A certification according to Regulation (EU) 2017/745 has a maximum duration of five years and can be combined with a subsequent audit cycle by applying for recertification.
The costs of a certification according to Regulation (EU) 2017/45
Why should companies choose DQS MED for MDR certification?
- Broad product portfolio of various normative and regulatory certification programs from one source
- Worldwide network with over 200 experienced assessors and experts