EU MDR 2017/745 Certification Services by DQS USA

Approval of medical devices for sale or distribution in the European Economic Area

On May 26, 2021, Regulation MDR (EU) 2017/745 replaced the former EU Directive on medical devices (93/42/EEC). As a legal basis, it describes requirements and conformity assessment procedures that must be met before medical devices are introduced into the European Economic Area. For medical devices of classes Is, Im, Ir, IIa, IIb, and III, cooperation with a Notified Body is required.

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

The new Regulation (EU) 2017/745 was published on May 5, 2017, and went into effect on May 25, 2021. For manufacturers of already approved medical devices, there is a transition period until May 26, 2024. During this time devices formerly certified under the previous Medical Device Directive MDD 93/42/EEC may continue to be placed on the market but are also subject to additional requirements under Regulation (EU) 2017/745.

Important changes for medical device manufacturers

Manufacturers of medical devices must expect major changes with the introduction of the MDR. The new regulation replaces the previous Medical Device Directive MDD 93/42/EEC and the Active Implantable Medical Devices Directive AIMD 90/385/EEC.

The changes in Regulation (EU) 2017/745 for medical device manufacturers.

In terms of content, the MDR differs seriously from the previous EU directives in a variety of ways. Among the most important changes are:

The expansion of the scope of application
Concretizations of the minimum content for the creation and maintenance of technical documentation
Tightening of the requirements for clinical evaluation
Introduction of a new control procedure for high-risk medical devices (so-called "scrutiny procedure")
A person responsible for regulatory compliance
Tightening of requirements for post-market surveillance of medical devices and the vigilance system
Improvement of identification and traceability of devices through the introduction of a unique product identification number (UDI system)
Promotion of transparency through a central European database (EUDAMED)
Obligation of manufacturers to provide coverage in the event of liability
The introduction of the new group of reusable surgical instruments
New classification rules including software, devices containing nanomaterials, and medical devices with material components

The changes to Regulation (EU) 2017/745 for Notified Bodies.

The new regulation pursues the goal of a European-wide uniform designation and monitoring of notified bodies based on concretized and tightened requirements. These more strict requirements have already led to a reduction in the number of notified bodies in Europe in recent years and further concentrations are expected.

What DQS Medizinprodukte GmbH as a Notified Body can do for you

DQS Medizinprodukte GmbH (DQS MED) can look back on a successful past as a Notified Body under Directive 93/42/EEC and has also been notified as a Notified Body under MDR 2017/745 by the Central Authority of the German Federal States for Health Protection regarding Medicinal Products and Medical Devices (ZLG).

With over 200 experts in the field of medical devices, we can offer a wide range of different certification procedures from a single source.

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.

After we have checked the information you have submitted, we will send you an initial quote for 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.

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.

The costs of a certification according to Regulation (EU) 2017/45

The cost of certification under Regulation (EU) 2017/745 depends on many factors. These include, for example, the size of your company, the complexity of your processes and your organizational structure, as well as your product portfolio, with special consideration of the risk classes of your medical devices and the number of your technical documentations. We will be happy to provide you with an individual offer.

Why should companies choose DQS MED for MDR certification?

Recognized expertise in medical devices for over 20 years
Active participation in standards and technical committees

Broad product portfolio of various normative and regulatory certification programs from one source
Worldwide network with over 200 experienced assessors and experts

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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.

Download here

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

Download here

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

ZIP

MDR Starter Kit 3

This document contains more information to assist you with the application.

Technical documentation guideline

ZIP

A patient monitoring medical device in a hospital

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.

Find our flyer here

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Regulation MDR (EU) 2017/745