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
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New Medical Device Regulation (EU) 2017/745 adopted by the European Parliament
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Important changes for medical device manufacturers
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The changes in Regulation (EU) 2017/745 for medical device manufacturers.
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The changes to Regulation (EU) 2017/745 for Notified Bodies.
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What DQS Medizinprodukte GmbH as a Notified Body can do for you
To learn more about MDR and have all your questions answered live, check out our upcoming 2023 DQS Medical Devices Roadshow here.
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The certification process according to MDR (EU) 2017/745
The first step is to provide us with the plans and goals of your certification project as well as some product-related information. It is especially important to provide us with your intended conformity procedure as well as intended purpose and risk classifications of your medical devices.
To accept our offer for certification, please submit the completed application form.
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 required to provide additional information and details.
Upon successful completion of the review, your application for certification will be accepted. Should we 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 reason, you will be asked to submit all required documents for evaluation. You will receive the result of each assessment in 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 during 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.
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.
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The costs of a certification according to Regulation (EU) 2017/45
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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
Basic data on the Medical Devices Regulation MDR (EU) 2017
If you are interested in a certification of a medical device according to MDR, you are at the right place.
We are pleased that you are interested in our certification and assessment services. We are happy to provide you with a cost estimate free of charge and with no obligation. For this we need some information about your company. Please fill out the basic MDR data and send it us. Please note that we also need the basic data list MP MDR for the procedure.
MDR Starter Kit 1
Here you will find the following information package for a seamless application process for MDR certification.
- Application procedure under MDR
- Information package
- Capacity assessment
- Guidance - Technical Documentation
- Overview of guidelines and recommendations
MDR Starter Kit 2
Here you fill find additional information to aid you the MDR certification application process.
- Basic data of the organization
- Basic data list
- Checklist GRUSULA
- Checklist technical documentation
- Submission of technical documentation
- Process flow
MDR Starter Kit 3
This document contains more information to assist you with the application.
- Technical documentation guideline
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Important information about the Medical Devices Regulation MDR (EU) 2017
This flyer will provide you with all the necessary information on Medical Device Regulation MDR (EU) 2017.