Chemical testing of medical devices

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 Many of the requirements of Directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD) – directives that have been superseded by the EU MDR – have been tightened.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.

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.

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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.

• 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.

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.

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!