Meeting MDR requirements
Manufacturers of reusable surgical instruments must comply with the requirements of the European Medical Device Regulation (MDR). An important part of this is the preparation and validation of cleaning, disinfection and sterilisation instructions in accordance with DIN EN ISO 17664 for Class I reusable (Class Ir) medical devices.
These instructions must demonstrate that medical devices can be cleaned, disinfected and reused safely and effectively. Thorough validation is essential to achieve compliance, ensure patient safety and gain market access.
Support throughout the validation process
Normec supports you throughout the entire validation process. Together, we identify the instruments that best represent your portfolio, define the appropriate test criteria and guide the execution of the validation studies.
Our practical approach provides not only valuable insight into the performance of your products but also the documentation required to demonstrate compliance with MDR requirements.
Complete validation from a single partner
Through our accredited chemical and microbiological laboratories, we perform all testing required to validate cleaning and sterilisation instructions. This gives you a single point of contact throughout the entire process.
This means you can:
- Demonstrate compliance with MDR requirements for reusable surgical instruments
- Receive support in developing instructions that comply with DIN EN ISO 17664
- Benefit from independent validation by an accredited laboratory
- Maintain full oversight through efficient documentation and reporting
- Manage test results centrally, even for extensive instrument portfolios
Expertise in reusable medical devices
Normec has extensive experience in validating reprocessing instructions for medical devices. Our specialists combine in-depth regulatory knowledge with practical laboratory expertise.
By bringing together our chemical and microbiological specialists, we can support both straightforward and highly complex validation projects. This provides a reliable foundation for your cleaning and sterilisation procedures.
Prepared for future MDR and market requirements
Requirements for reusable medical devices continue to evolve. By investing today in well-documented and validated reprocessing instructions, you reduce future compliance risks and strengthen your market position.
Normec helps you comply not only with today's regulations but also prepare for future regulatory developments.
Would you like to learn more about the validation of cleaning and sterilisation instructions?
Frequently Asked Questions
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DIN EN ISO 17664 is the standard that specifies the information manufacturers must provide for the cleaning, disinfection and sterilisation of reusable medical devices.
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This validation is relevant for reusable surgical instruments and other reusable medical devices for which reprocessing instructions are required.
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Validation demonstrates that the specified cleaning and sterilisation procedures are effective and can be carried out safely.
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Yes. We help identify representative instruments and define suitable test criteria for the validation process.
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Yes. Validation is carried out in our own accredited chemical and microbiological laboratories.
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Yes. For organisations with extensive product portfolios, we offer database solutions for managing and analysing test results.
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An accredited laboratory operates in accordance with recognised quality standards, providing reliable results and strong evidence for regulatory authorities and notified bodies.