Did your product fail testing?
A letter from the Regional Authority informs you that your product was tested as part of a random sample and failed the test miserably.
What happened and what follows now
- A possible (near) incident that has to be reported?
- A product recall?
- Compensation payments?
- Why was the model that was actually tested positively able to fail the random test?
Product testing is part of the daily routine of all medical device manufacturers. As part of the conformity assessment procedure, you must verify the statements you have made.
Country-specific listing and registration systems also require evidence for:
- Performance claim and
- Special functions
For many product types, there are now test standards that are partially harmonised. Harmonisation means that the test standard is suitable for fulfilling or partially fulfilling the Essential Safety and Performance Requirements according to Annex I of the MDR (European Medical Devices Regulation).
In the context of device registrations, there are sometimes special GKV approved test procedures that must be applied.
If you are not lucky enough to find a product-specific standard, use standards that describe usable test procedures.
The decisive factor is that the suitability and effectiveness of the risk-minimising measure resulting from and described in the risk management can be proven.
A well-configured test sample is the be-all and end-all
Wheelchair manufacturers, for example, have the two standards EN 12183 (manual wheelchairs) and EN 12184 (electric wheelchairs). These examples comprehensively describe requirements and tests that are suitable to prove the safety and performance of the products.
These examples comprehensively describe requirements and tests that are suitable to prove the safety and performance of the products. However, this example also provides a good illustration of how a cost-intensive test can ultimately go wrong. This does not mean that the test was not passed, but that the incorrectly configured test sample was sent to the test center, resulting in repeat or duplicate tests later on.
Especially in strength or stability tests, the most unfavorable configuration, i.e. the weakest configuration, should always be tested. This means that often not one sample but 2 to 3 samples have to be provided.
Many test centers also pay attention to this or point out that it should be the largest seat width when it comes to strength. The smallest seat width, in turn, when it comes to tilt stability. You will get these indications if the testers are attentive and the required information is available. But if there is no product information, the selection of a well-configured test sample that provides a lot of evidence in just a few test steps is simply not possible. It becomes really unpleasant when a gap in information is pointed out during a listing procedure, which leads to renewed testing. It is also possible that authorities will come to negative test results in the course of spot checks and then demand a product recall. You may have a similar problem if you change the wiring of your medical device after EMC testing (electromagnetic compatibility) according to IEC 60601-1-2. 2 Examples of serious problems from everyday life that are actually avoidable.
Testing must be well planned and test samples properly configured.
Stay on the safe and less expensive side with your product and verification measures. Testing must be well planned and test samples properly configured. Discuss your goals with us and test once but properly, then neither random samples, nor nationally deviating requirements will be a hurdle for you.