CE Mark for Medical Devices

Do you have a great idea for a medical device and need a partner to realize it and apply a CE mark at a notified body? Read through some challenges you will encounter developing and approving medical devices. Learn what to look out for in terms of R&D, quality and regulatory capacity in the CE certification medical devices.

BAAT is an experienced partner and expert in medical device development. We have the experience and know-how to transform your dream, idea, technology or problem into a product with manufacturing route, CE mark and supply chain management.

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CE mark medical device - FAQ's

You find the CE mark on toys, electronics, protective clothing, and many other products sold in Europe. CE marking was introduced to support the EU’s goal of removing trade barriers within the EU. Originally, products with possible safety, health or environmental issues had to be approved by each country. Now, national legislation is harmonized into Europe-wide directives or regulations; if manufacturers guarantee both the product and testing is conform these directives, they have access to all EU countries at once. Manufacturers must put the CE mark on their products to signal they conform to the applicable European directives.

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Responsibility for your product taken care of

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Innovate

How to maximize your impact

How do you know what product will be successful in the future? What is the context of the current treatment? How is this context evolving? By asking smart questions and getting objective answers using both systematic and proven methods, we find out together how to maximize your impact in the healthcare- and medical device industry.

R & D

We can develop your product

How to meet all technical requirements? What regulatory pathway should be taken? How should I organize my clinical evaluation? We know all about design, engineering, and validation, and understand what is needed to pass the notified body and FDA and get market approval for your product, including CE marking.

Operations

We can supply your product

Proving that all manufacturing processes of your product are controlled (to ensure that they repetitively deliver the desired results) is more demanding than ever, due to ever-increasing regulations. Medical devices must also be fully traceable from raw material to clinical use. We can handle these operations, so you can focus on sales.

Legal Manufacturer

We can take responsibility for your
product

Legal Manufacturers must continuously evaluate the clinical performance of their product and demonstrate that it complies with all regulations. Legal Manufacturers also need to fulfil all requirements related to both quality- and regulatory management. We take full responsibility for you, so you can focus on product innovation.

How do you know what product will be successful in the future? What is the context of the current treatment? How is this context evolving? By asking smart questions and getting objective answers using both systematic and proven methods, we find out together how to maximize your impact in the healthcare- and medical device industry.

How to meet all technical requirements? What regulatory pathway should be taken? How should I organize my clinical evaluation? We know all about design, engineering, and validation, and understand what is needed to pass the notified body and FDA and get market approval for your product, including CE marking.

Proving that all manufacturing processes of your product are controlled (to ensure that they repetitively deliver the desired results) is more demanding than ever, due to ever-increasing regulations. Medical devices must also be fully traceable from raw material to clinical use. We can handle these operations, so you can focus on sales.

Legal Manufacturers must continuously evaluate the clinical performance of their product and demonstrate that it complies with all regulations. Legal Manufacturers also need to fulfil all requirements related to both quality- and regulatory management. We take full responsibility for you, so you can focus on product innovation.

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Notified body & CE mark

Did you know that as a manufacturer, you must officially declare that your product conforms to the CE mark medical device requirements? This declaration requires technical documentation, to support your ‘case’ in that your development process, and resulting medical products, are manufactured and tested conform all regulations.

Medical devices are divided into different risk classes. For the lowest risk class manufacturers may self-certify. Meaning they themselves can draw the conclusion that the technical documentation proves conformity with the regulations and put a CE mark on it.

Example of a medical device CE mark medical device, using notified body CE mark ‘CE 0344’

For medium or high-risk medical devices, conformity with the regulations cannot be done by the manufacturer; a Notified Body must assess conformity before it can be placed on the market. What is a notified body in CE marking? These are organisations designated by member states of the EU who can assess conformity with specific regulations.

Medical products can only be assessed by organisations with a notified body certification specifically for assessing medical devices. The number of the Notified Body involved in the assessment must be shown; an implant assessed by the Notified Body MedCert will show ‘CE 0482’ and shown here is an example of Dekra ‘CE 0344’ as Notified Body.

Get your device CE marked

When you transform your idea into an approved medical device, you will encounter hurdles. BAAT is successfully guiding customers to overcome these hurdles since 1999. Contact us today to use this experience to navigate the intricacies of working with a notified body and CE mark medical devices.

As your full-service medical device company, we’re partners for the complete journey and are only satisfied when your medical device is CE marked and successfully treating patients.

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Get your medical device CE marked and successfully treat patients.

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More Engineering challenges and asking the right questions

Asking the right questions is the first step to a successful project. Having impact on the end user means impact in the market. Some examples:

  • How do you know what product will be successful in the future?
  • What regulatory pathway should be taken?
  • How can we ensure the medical device is fully monitored and traceable from raw material to clinical use?
  • How is the clinical performance tracked and market access ensured?

One of the steps many customers do is answering above questions using an Innovation Scan. We call it ‘Innoscan’. Get in contact with Baat to see what can lead to a commercially viable product development and real impact in the medical device business.

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ISO 13485 Certification

Our ISO 13485 quality system (certificates) concerns topics directly related to product development (e.g. verification and validation, risk management, usability), but also addresses many high-level topics such as competence tracking and training, management of standards, control of documents.

When partnering with BAAT, you will not only benefit from the knowledge and experience of our 25+ people with various fields of expertise, our expertise with medical device engineering for both the EU and US markets with 30+ products developed (projects), but also of our underlying quality system.

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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.
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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.
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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!
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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.
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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.