MDD 93 42 eec

Are you a manufacturer or importer of medical devices and do you do business in the EU/EEA? Then make sure your products meet legal requirements in the area of safety and health.

Directive 93/42/EEC

The MDD 93 42 EEC directive stipulates that medical devices and accessories may only be authorised and marketed in the European market if they have CE marking. For this, the manufacturer must carry out a conformity assessment procedure (or have it carried out). Baat Medical has managed to do conformity assessment for a range of products, including joint implants, spinal implants, orthoses, and many more.

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Defenitions for mdd 93 42 eec

Article 1(2) of the Directive defines a medical device as “any instrument, apparatus, appliance, material, software or other article intended by the manufacturer to be used in human beings for the detection, treatment, alleviation or prevention of disease, injury or disability. Devices for the control of fertilization and devices for research into (or modification of) anatomical and physiological processes are also covered.

On May 26, 2021, Directive 93/42/EEC will be repealed and succeeded by Regulation (EU) 2017/745.

Medical devices for in vitro diagnostics and active implantable devices are covered by other, separate CE directives.

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How do you know which medical innovations are successful in the future? By asking smart questions, we find out together how to maximize your impact with 90 385 eec regulations now and in the future.

R & D

We can develop your product

How to meet technical specifications? What regulatory mdd 93/42 pathway should be taken? We have extensive experience in design, engineering, validation, and know what is needed to pass the notified body and the FDA.

Operations

We can supply your product

How to meet increasing requirements for directive 93/42/eec product delivery? We are able to streamline your operations, take care of traceability and handle post market surveillance on all levels, letting you focus on sales.

Legal Manufacturer

We can take responsibility for your
product

How does your company comply with the ever increasing demands from notified bodies? Take responsibility by outsourcing this to Baat Medical and let us be your legal manufacturer. We are legal manufacturer for several of our customer’s products while our customers always hold IP.

How do you know which medical innovations are successful in the future? By asking smart questions, we find out together how to maximize your impact with 90 385 eec regulations now and in the future.

How to meet technical specifications? What regulatory mdd 93/42 pathway should be taken? We have extensive experience in design, engineering, validation, and know what is needed to pass the notified body and the FDA.

How to meet increasing requirements for directive 93/42/eec product delivery? We are able to streamline your operations, take care of traceability and handle post market surveillance on all levels, letting you focus on sales.

How does your company comply with the ever increasing demands from notified bodies? Take responsibility by outsourcing this to Baat Medical and let us be your legal manufacturer. We are legal manufacturer for several of our customer’s products while our customers always hold IP.

mdd 93/42

Exclusions for the 90 385 eec directive

The directive does not apply – with some exceptions – to:

  • devices intended for in vitro diagnosis
  • active implantable devices
  • medicinal products for human use
  • cosmetic products
  • human blood, blood plasma, blood cells or products thereof;
  • transplants, tissues or cells of human or animal origin.
  • Essential requirements

Medical devices must meet certain essential health and safety requirements. These requirements are described in Annex I of the directive. The requirements cover the technical and constructive safety, sterility, bio-compatibility and any measurement functions and energy sources of the devices. The Annex also provides instructions for indications on product labels and instructions for use.

In general, medical devices meet the requirements of the directive if they comply fully with the applicable harmonized standards for these products. In the Netherlands, you can request the relevant standards sheets from standardization institute NEN.

Details for medical device manufacturers

In the Netherlands, manufacturers of medical devices of risk class I must register their products via Farmatec’s online registration system (Notis) before placing them on the Dutch or European market. Farmatec is part of CIBG, an executive organisation of the Ministry of Health, Welfare and Sport (VWS).

Conformity assessment

Determine precisely the procedure by which you must assess the conformity of your product. This differs per risk class. Medical devices are divided into 4 risk classes:

  • Class I (low risk)
  • Class IIa and IIb (medium risk)
  • Class III (high risk)

The classification rules for these can be found in Annex IX of the directive. The assessment procedures are described in general terms in Article 11 and in more detail in Annexes II to VII. For each class of risk you can choose from 2 or more possibilities for assessing your product against the essential requirements.

You must always involve a notified body in the assessment of devices in classes IIa, IIb and III. For Class I devices, involvement of a notified body is only required if your products have a measuring function or are marketed in a sterile condition.

After inspection, the notified body issues an inspection report or inspection certificate to the manufacturer.

Directive 93/42/EEC and mdd 93 42 for spine implant baat medical

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Technical documentation

As the manufacturer, you must prepare technical documentation. To do this, you use the instructions in the annexes (II to VII) to the directive that apply to your product and risk class. You must keep this documentation at the disposal of national market surveillance authorities in the EU/EEA countries for at least 5 years, who may request access to it. The documentation must enable market surveillance authorities to assess whether your product complies with the requirements of the Directive.

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EC declaration of conformity

Before placing your product on the market, as a medical device manufacturer, you must prepare and sign an EC Declaration of Conformity. You add this declaration to your technical documentation. With this act you take full responsibility for the conformity of your product to the requirements of the directive.

The procedures for this declaration are detailed in Article 11, Annex II and Annexes V to VIII. You should retain the declaration for at least 5 years from the date the device was placed on the market.

CE marking

If the devices meet all the essential requirements, affix the CE marking. Instructions for this can be found in Article 17 and Annex XII of the directive. Did you involve a notified body in the conformity assessment? If so, you must also state their identification number with the CE marking.

The CE marking is not required for devices that you make on prescription for an individual patient or that are intended for clinical research.

  • What concept works for all users (patient, OR assistant, surgeon, etc.)?
  • How can all users safely and effectively use the medical device?
  • How can we prove safety and performance of the medical instrument design for the patient and other users?
  • How can we ensure the medical device is fully monitored and traceable from raw material to clinical use?
  • How is the clinical performance of the medical device tracked and continued access to the market ensured?

When you transform your idea into an approved biomedical device design you will encounter hurdles. BAAT is successfully guiding customers to overcome these hurdles since 1999. Use this experience to navigate the intricacies of your medical device and development and get your product approved for market introduction.

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Our Customers About Us

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Nancy Lamerigts MD PhD
Inspine
Baat Medical is our reliable R&D partner in various projects. The project with EIT Cellular Titanium®️ medical development has been the cherry on the pie (so far)! Can't wait what next projects are going to bring us.
Oliver Hass, Essity, is a Baat Medical customer
Dr. Oliver Hass
BSN Medical | Essity
A great thanks to everyone at Baat medical involved in this project. We are very satisfied with your service (including performance, communication, and flexibility) and are looking forward to possible new collaborations.
Dr Hans Joachim Fischer-Baat Medical Engineering brings medical innovations to market. Commercial viability is a leading metric in medical device innovation succes.-Baat Medical Engineering brings medical innovations to market.
Dr. Hans-Joachim Fischer
Waldemar Link
The engineering services of Baat really complements our own design process, while seamlessly integrating into our existing operations.
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Pablo Enriquez
Belfry Medical GmbH
Successful products are not made only of great ideas; they require a good understanding of todays and tomorrows market environment. INNOVATE helped us to decide what is necessary to fulfil all stakeholders’ present and future requirements for a high impact product and treatment. BAAT did a great job!
Guntmar Eisen, a Baat Medical customer
Guntmar Eisen
EIT, a J&J company
Thanks to the close collaboration of our engineers with the BAAT team, we could execute our development strategy as planned. We couldn’t have reached this level of success without them.
Ariaan-van-Walsum-Baat Medical Engineering brings medical innovations to market. Commercial viability is a leading metric in medical device innovation succes.
Ariaan D.P. van Walsum
Trauma Surgeon, MST Enschede
Baat Medical has made my idea come true. It really contributes to better care for the patient, and to the convenience of surgeons. It's great to work together to realize a medical innovation. I can recommend Baat 100% to surgeons and hospitals that really want to make a move.