MDR& Reusable Devices
The new standards are more organized and rigorous than previous versions – especially with the heightened scrutiny of patient-contacting, critical-reusable medical devices. The experts at Nelson Labs are able to help manufacturers evaluate changes in regulatory standards under which previous testing was performed compared to the most current regulatory standards. For example:
- New classifications for reusable surgical devices requiring notified body oversight.
- The broadened definition of medical devices to include non-medical and cosmetic devices not previously regulated – some of which require processing validations.
- Increased scope of cleaning instructions and associated validations. Notified Body assessment will now include areas such as disinfection, sterilization, maintenance, and functional testing (Article 52 of the MDR).
- No “grandfathering” provision – on May 2020 all previously approved devices will have three years to be recertified under the new rules.
Reusable Device Processing Approach:
Manufacturers of medical devices need to validate the processing that occurs in the health care facility between patient uses. Our experts will analyze the risk, determine the appropriate test plan, and interpret the test results.
- Create a Risk Analysis: this includes the device materials and device complexities, surgical procedure, and regulatory requirements.
- Create and execute the Test Plan: document and compare to current regulatory standards all test articles, controls, processing specifications, residual testing, and acceptance criteria.
- Conclusion: gathering and interpreting the test results and show how the results meet the acceptance criteria outlined in the test plan.
The MDR defines a reusable surgical instrument as “an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilization have been carried out.” (Annex VIII, Chapter I, Section 2.3)
Regarding the appropriate validations that need to take place, the MDR gives guidance stating that “if the device is reusable, information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging, and where appropriate, the validated method of re-sterilization appropriate to the Member State or Member States in which the device has been placed on the market. Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses.” Annex I, Chapter III, Section 23.4 (n)
Understanding these new regulations and getting prepared to meet them is no small undertaking. That is why the expert advisors at Nelson Labs are ready to help you understand your testing needs and get your products certified and safely to those patients who need them.
The deadlines are quickly approaching, let us help you create a gap analysis and a clear strategy for meeting this new MDR.