current language
World Site available in the following languages:
or select your TÜV Rheinland region / country website:
Choose country/ region and language

Chemical testing of medical devices

TÜV Rheinland experts perform chemical tests on medical devices. | TÜV Rheinland

Meet the MDR requirements for a successful market launch

Medical devices are subject to a variety of strict regulations. Therefore, the Medical Device Regulation (EU MDR) also includes requirements for the chemical safety of products. The EU MDR, published in 2017, specifies the conditions for placing a medical device on the market in the European Union. Many of the requirements of Directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD) – directives that have been superseded by the EU MDR – have been tightened. The EU MDR also references additional relevant laws and regulations that may apply to a specific product.

With regard to chemical safety, the key requirements are outlined in the MDR itself, as well as in the REACH Regulation (EC) No. 1907/2006, POP Regulation (EU) 2019/1021 and RoHS Directive 2011/65/EU. In addition, there is the SVHC list. It is the list of substances of very high concern (SVHC) that are candidates for authorization, published in accordance with Article 59(10) of the REACH Regulation. As market authorization holders, manufacturers and distributors are responsible for compliance with all requirements. Failure to do so may result in a loss of approval for the European market as well as in penalties and loss of reputation.

Our experts have a comprehensive understanding of the applicable requirements, standards and regulations and can support you in developing your target market.

Chemical testing of medical devices

Figure; contents covered by REACH, POP, RoHS and SVHC | TÜV Rheinland

How do you ensure the chemical safety of your product along the entire supply chain? How do you keep track of the increasingly stricter limits for individual substances in the various markets?

As a world-class provider of testing and certification services for medical devices, we offer comprehensive testing to establish compliance with chemical regulations in order to ensure that your products are ready for the European and global markets.

To avoid unpleasant surprises, we offer screening tests. With the help of our international network of recognized laboratories, we will test your product for compliance with applicable regulatory requirements such as:

  • REACH Regulation Annex XVII
  • REACH SVHC
  • POP Regulation
  • RoHS Directive
  • US Prop65
  • Other

These tests are a useful complement to your risk analysis. Together, they allow you to demonstrate both compliance with regulatory requirements related to hazardous substances, and your due diligence.

Please contact us about it!

For suppliers: Early consideration of limit values and requirements

Chemical testing of substances, materials, and components for medical devices | TÜV Rheinland

Suppliers have an obligation as well. The source materials, materials, and components they supply must comply with the applicable legal requirements. If a limit value violation on the finished product can be traced back to a specific component, its supplier will suffer an enormous loss of reputation.

We will be happy to provide you with information on the relevant legal requirements so that you can position yourself and your substances, materials, and components successfully in the international competition.

Your partner for the safety of medical devices

  • Experience and expertise: Our many years of experience and our extensive know-how will give you confidence in our testing. Our expertise will help you ensure the conformity of your products.
  • Fast and thorough: Along with a comprehensive portfolio of services, we provide fast turnaround of testing for your successful market launch. Over the years, we have continuously optimized our processes to offer you a fast response time and a professional management of your orders for testing.
  • State-of-the-art equipment: We are aware of the constant progress in the advancement of medical devices. We support you in this development and are expanding and updating our testing facilities to ensure that your products are being tested according to the latest test methods and technologies. Because of our long-term investments, we have high testing capacities.
  • Personal touch: Thanks to our global presence, the nearest TÜV Rheinland expert for medical devices is never far away from you. In an initial meeting, we will answer your specific questions about the testing of your products.

New: Testing according to DIN EN ISO 10993-18

The particular standard DIN EN ISO 10993-18 is of significant importance in the testing of medical devices. It addresses the 'chemical characterization of medical device materials within a risk management process'. The objective is to analyze the chemical properties of materials used in medical devices and to assess their biological safety.

TÜV Rheinland will conduct this test for you. We will identify and quantify all substances released from your products that may cause chemical reactions when brought into contact with patients. This will confirm the safety of your medical devices early in the development process, thus avoiding the necessity for significant adjustments to be made at a later stage.

The combination of state-of-the-art laboratory equipment and extensive experience within and beyond the medical field enables us to offer customized tests and precise results in just 1 to 2 weeks. In cases where only minor modifications have been made to a previously tested product, a focused comparative test can be applied to save time and accelerate the approval process for the revised model.

Another advantage of our test results lies in their partial coverage of the particular standard
DIN EN ISO 10993-17, eliminating the need for animal testing!

Our team of experts is available to provide advice and to offer customized solutions.

Whitepaper: EU MDR and the Impact on Chemical Substances in Medical Products

At TÜV Rheinland, our experts are happy to share their knowledge with you. Our whitepaper dives deep into the implications of the new MDR for chemical substances used in the manufacture of medical devices. It also outlines proposed solutions and long-term considerations for ensuring compliance in the future.

Don't miss out on this opportunity to unlock the full potential of your medical products. Download our whitepaper today and take the first step towards transforming your operations!

Useful documents for testing your medical devices

pdf Flyer - Guidance for MDR Technical Documentation Submission 511 KB Download
png Infografik – Key facts about the MDR revision 391 KB Download
pdf Flyer - IEC 60601-1 Fact Sheet 359 KB Download
pdf Flyer - Characterization of medical products 426 KB Download
pdf Flyer - EU MDR and hazardous substances 1 MB Download

This might also interest you

EU Medical Device Regulation MDR 2017/745

EU Medical Device Regulation MDR 2017/745

Supporting access to European markets for medical devices under MDR 2017/745.

discover more

Non-Active Medical Device Testing

Guarantee the quality of your non-active medical devices with a GM test mark | TÜV Rheinland

Increase your competitive edge and certify your non-active medical device products.

discover more

Active and Non-Active Medical Devices

Active und Non-Active Medical Devices

Active and Non-Active Medical Devices.

discover more

International Approval for Medical Devices

International Approval for Medical Devices

Your Gateway to New Markets.

discover more

IEC 60601 Series – Medical Electrical Equipment

Medical Electrical Equipment testing IEC 60601-1 (UL 60601-1, EN 60601, ES 60601) - TÜV Rheinland

Test medical electrical equipment for compliance with IEC 60601-1 standard and beyond.

discover more

CB Certificate

CB report as basis for several national certifications

CB certification as a globally recognized method for testing the safety of electrical devices.

discover more

CE Marking

CE Marking

Transparency and Safety on European Markets.

discover more

Surprisingly Transparent. The TÜV Rheinland Test Mark

Surprisingly Transparent. The TÜV Rheinland Test Mark

Certipedia - The free online certificate database for tested and certified products.

discover more

EN ISO 13485 certification of QMS for medical devices | TÜV Rheinland

EN ISO 13485 certification of QMS for medical devices | TÜV Rheinland

Certify your Quality Management System (QMS) for medical devices

discover more

Focus on cybersecurity: meeting EU requirements for networked devices

Focus on cybersecurity: meeting EU requirements for networked devices

Become cyber-resilient! With TÜV Rheinland, you can prepare your networked devices for the new requirements of the EU Cyber Resilience Act and ensure maximum IT security.
Take the CRA Readiness Check now!

Ensure chemical safety for your medical devices

Contact us to request a non-binding offer

Contact us to request a non-binding offer

Take the next step!

Last Visited Service Pages