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. If your produce medical devices of classes Is, Im, Ir, IIa, IIb and III, cooperation with a Notified Body, such as DQS Australia / New Zealand may be required.  The regulation can be found on the on the European Law website, and also from the UK legislation website

As an appropriately designated European notified body, DQS is able to issue conformity assessment certification under the Therapeutic Goods Act 1989   More information about the MRA (Mutual Recognition Agreements) can be found here https://www.tga.gov.au/medical-devices-reforms-mutual-recognition-agreements-mra.

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 European Union's New Medical Device Regulation (EU) 2017/745 has been adopted by the European Parliament and came into force on May 25, 2021. While this regulation primarily affects manufacturers in the EU, it is crucial for medical device manufacturers in Australia and New Zealand who wish to access the European market.

Important Dates and Transition Period

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. However, it's essential to be aware that they will also be subject to additional requirements under Regulation (EU) 2017/745.

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Prozessorientierung
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Changes for medical device manufacturers

The introduction of the MDR brings far-reaching changes for medical device manufacturers. This 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 significantly differs from the previous EU directives.

Gesetze
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Key Innovations and Requirements in Regulation (EU) 2017/745

The MDR introduces numerous key innovations and requirements, including:

  1. Expanded Scope of Application: The MDR broadens the scope of application for medical devices.
  2. Enhanced Technical Documentation: Minimum content requirements for the creation and maintenance of technical documentation are now specified.
  3. Stricter Clinical Evaluation Requirements: The requirements for clinical evaluation are tightened.
  4. Scrutiny Procedure for High-Risk Devices: A new control procedure for high-risk medical devices is introduced.
  5. Person Responsible for Regulatory Compliance: Manufacturers are now required to have a designated person responsible for regulatory compliance.
  6. Post-Market Surveillance and Vigilance System: Requirements for post-market surveillance of medical devices and the vigilance system are enhanced.
  7. Unique Product Identification Number (UDI System): Devices are now required to have a unique product identification number to improve identification and traceability.
  8. Central European Database (EUDAMED): Transparency is promoted through the establishment of a central European database.
  9. Liability Coverage: Manufacturers must provide coverage in the event of liability.
  10. Reusable Surgical Instruments: A new group of reusable surgical instruments is introduced.
  11. New Classification Rules: There are numerous new classification rules, including those for software and devices containing nanomaterials.
Anforderungen
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Changes for Notified Bodies.

The MDR also impacts Notified Bodies. The new regulation aims to achieve Europe-wide uniform designation and monitoring of notified bodies based on concretized and tightened requirements. This has already led to a reduction in the number of notified bodies in Europe in recent years, and further concentrations are foreseeable.

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What DQS as a Notified Body can do for you

We have a successful history as a Notified Body under Directive 93/42/EEC and are also 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 over 200 experts in the field of medical devices, we offer a wide range of certification procedures from a single source, catering to the needs of medical device manufacturers in Australia and New Zealand who wish to access the European market.

For more information on how we can support your compliance with the new MDR and assist with certifications, please contact us.

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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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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 will be happy to provide you with a non-binding cost estimate free of charge. 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.

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Your local contact person

We will be happy to provide you with a customized offer for MDR (EU) 2017/745 certification.