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

Since May 26, 2021, Regulation MDR (EU) 2017/745 replaces 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

Grundsätze
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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 came into force on May 25, 2021. For manufacturers of already approved medical devices, there is a transition period until May 26, 2024, during which 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.

Prozessorientierung
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Far-reaching 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. In terms of content, the MDR differs seriously from the previous EU directives.

Gesetze
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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 many respects. Among the most important innovations 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, and numerous new classification rules, including for software, devices containing nanomaterials, and devices containing nanomaterials, including for software, devices containing nanomaterials, and medical devices with material components.

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

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

Partner
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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 with regard to Medicinal Products and Medical Devices (ZLG).

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

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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.

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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.

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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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We would be happy to provide you with a customized offer for MDR Certification.