MDR (EU) 2017 / 745

Certification process
 

For information regarding our services, please visit
www.dqs-med.de or contact us at any of our events. Naturally, you can also contact your customer service representative or our sales staff via email: vertrieb(at)dqs-med.de.

To provide you with our services, we require a description of your intended certification project, as well as some product-related information. Essential are here, above all, the intended use and the respective risk classification of your products. Please send us the above-mentioned required information about your company using the DQS MED basic data template.

You will receive a quotation, also specifying the estimated efforts for audit and Technical File Review, based on the information provided and documents submitted by you.
This package will also include the application forms.

It may be necessary to provide additional information for clarification.
To accept the quotation, please sign and subsequently submit the completed application form.

Important note: As outlined in the application form, your conformity assessment procedure according to VO (EU) 2017/745 will start with receipt of your completed application form. The application itself does not guarantee certification. Please be aware of our reporting obligations stated in our general terms and conditions.

As a first step, your application and the information you provided are checked and the result is documented.

Important note: If the application has to be rejected, now or at a later point in time, for technical or formal reasons, or, if you decide to withdraw it, we have to fulfil our reporting obligations according to VO (EU) 2017/745.

With the acceptance of your application, you have already passed the first hurdle!

Now, the detailed planning of your certification procedure starts.

First of all, the required review(s) of the technical file(s) take(s) place. The result of the review(s) is summarized in reports and used in the further course of the conformity assessment procedure. You will receive a copy of these reports.

Important note: During the course of the technical file review you will have the opportunity for corrections. However, in case of new applications, we must stop your conformity assessment procedure after the third rework failed. This will result in reporting obligations for us, according to VO (EU) 2017/745.

Now, the system analysis (stage 1) takes place. It consists of reviewing the QMS documentation and your described procedures.

The question which needs to be clarified:
Is your system ready for the next step?

The results of the system analysis will be summarized in a report and used in the further course of the conformity assessment procedure.
Naturally, you will receive a copy of this report as well.

First of all, the required review(s) of the technical file(s) take(s) place. The result of the review(s) is summarized in reports and used in the further course of the conformity assessment procedure. You will receive a copy of these reports.

Important note: During the course of the technical file review you will have the opportunity for corrections. However, in case of new applications, we must stop your conformity assessment procedure after the third rework failed. This will result in reporting obligations for us, according to VO (EU) 2017/745.

Now, the system analysis (stage 1) takes place. It consists of reviewing the QMS documentation and your described procedures.

The question which needs to be clarified:
Is your system ready for the next step?

The results of the system analysis will be summarized in a report and used in the further course of the conformity assessment procedure.
Naturally, you will receive a copy of this report as well.

We combine the results of the technical file reviews and the system analysis (stage 1) and assess whether the system assessment, that follows in the next step, can be carried out as planned or any adjustments (e.g. to the audit content) need to be made.

Important note: We must stop your conformity assessment procedure, if, even at the third attempt, you fail to demonstrate sufficient readiness for the following system assessment. This will again result in reporting obligations for us, according to VO (EU) 2017/745.

The system assessment (stage 2) always takes place at your premises, as known from other certification programs.

However, audits under VO (EU) 2017/745 will include some changes, such as the onsite verification of specifications from the technical files and, if applicable, with respective samples.

The results of the system assessment (stage 2) will also be summarized in a report.
In case any non-conformities were identified during the audit, they are also part of this report.
The report will conclude with the assessors’ recommendation for certification.

The results of the system assessment will now be checked by the reviewer, confirming or rejecting the assessors’ certification recommendation. If questions remain open in the report, further rework may be required. In this case, we will get in touch with you.

Important note: In the case of new applications, we have to conclude the conformity assessment procedure negatively, after the third negative final review.
This will result in a reporting obligation for us, according to VO (EU) 2017/745.

DQS MED stands for high quality, which we safeguard through extensive internal quality assurance procedures.
As such we installed an overriding Certification Decision Board, ensuring that certification decisions are adequate and that corresponding action is taken accordingly.

Congratulations, your certification has been granted!

You will now receive your certificate and the system assessment report.

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