Reusable Medical Devices Tests

Reusable Medical Devices Tests

If you need help understanding the requirements or would like someone to help conduct a gap analysis for current compliance as you plan your MDR migration strategy, EUROLABYou can trust 's expert consultant team and state-of-the-art laboratories. The details of the evaluation process will depend on the number and range of devices being evaluated and their clinical use history.

Reusable Medical Devices Tests

Below to help you address MDR EUROLABHere are examples of services that can offer you:

Gap Analysis:

The new standards are more organized and rigorous than previous versions – with strict guidelines in place, especially for issues such as increased scrutiny of patient-contact, critical reusable medical devices. EUROLABExperts at can help manufacturers evaluate changes to regulatory standards where previous testing was performed compared to the latest regulatory standards. For example:

  • New classifications for reusable surgical devices that require approved body supervision.
  • Expanded definition of medical devices to include non-medical and cosmetic devices that have not been previously edited - some require processing validations
  • Scope of cleaning instructions and associated verifications. The Notified Body assessment will now include areas such as disinfection, sterilization, maintenance and functional testing (MDR Article 52).
  • There will be three years for all devices pre-approved in May 2020 to be recertified under the new rules.

Reusable Device Processing Approach:

Medical device manufacturers are required to verify transactions that occur between patient uses in the healthcare facility. Our experts will analyze the risk, determine the appropriate test plan and interpret the test results.

  • We Create a Risk Analysis : this includes device materials and device complexities, surgical procedure and legal requirements.
  • We create and execute the Test Plan : we compare all test articles, controls, processing specifications, residue tests and acceptance criteria with applicable regulatory standards.
  • Conclusion : we collect and interpret test results and show how the results meet the acceptance criteria specified in the test plan.

MDR reusable surgical instrument “designed for surgical use in cutting, piercing, cutting, scraping, scraping, clamping, retracting, trimming or similar procedures without connection to an active device and can be reused by the manufacturer after proper procedures such as cleaning, disinfection and sterilization have been performed. . ”Defines as. (Annex VIII, Section I, Section 2.3)

Regarding the appropriate verifications that must be carried out, the MDR “provides guidance on appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of resterilization, if the device is reusable. Suitable for the Member State or Member States where the device is placed on the market. Information should be provided to indicate when the device should no longer be reused, eg material deterioration or the maximum number of reuse allowed. ”Annex I, Section III, Section 23.4 (n)

Understanding these new regulations and preparing to meet them is no small undertaking. Because EUROLABThe expert consultants at are ready to help you understand your testing needs and get your products certified and safe to the patients who need them.

EUROLAB, with its highly expert team and internationally accredited laboratories, Reusable Medical Devices Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.