Implementation questions

1. Do I need to perform mechanical tests on the liner? If so, which organization can do this?

You are the ones who determine the tests that need to be performed on your product. If this test is crucial to show that your product meets the specifications, then a test is needed.

As for the laboratories where the test needs to be conducted, MDR requires it to be some accredited institution.

However, we are not authorized to refer you to the appropriate institutions because we do not know your product and its specifications.

2. How long do I need to do clinical trials on the liner? How many months and how many patients need to wear the liner as part of the clinical trials?

Clinical trials for medical devices must be prepared in accordance with the standard ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice. How long the research will take depends on many factors, which are listed in this standard.

However, please be aware that clinical trials are necessary for those medical devices that are completely new and that there is no other source for clinical data. So, usually, it is for completely new types of medical devices, with new technologies or materials.

For all other medical devices, it is possible to perform the clinical evaluation with the available clinical and scientific data for the literature (Article 61 in the MDR 2017/745). If I understand what silicone prosthetic liner is, it is not a new device, therefore you can find a lot of clinical data on the internet. When you use literature data for your medical device, you need to find an equivalent device with which you will compare your medical device. Equivalence must be demonstrated at the clinical, technological, and biological levels.

For more information, see:

• EU MDR Article 61 – Clinical evaluation https://advisera.com/13485academy/mdr/clinical-evaluation/

• EU MDR Annex 14 Clinical evaluation and post-market-clinical-follow-up https://advisera.com/13485academy/mdr/clinical-evaluation-and-post-market-clinical-follow-up/

On the following links you can find how we have prepared in the ISO 13485&MDR Documentation toolkit documents and reports for clinical evaluation:

• Procedure for Clinical Evaluation https://advisera.com/13485academy/documentation/procedure-for-clinical-evaluation/
• Clinical Evaluation Plan https://advisera.com/13485academy/documentation/clinical-evaluation-plan/
• Clinical Evaluation Report https://advisera.com/13485academy/documentation/clinical-evaluation-report/
• Literature Research Protocol https://advisera.com/13485academy/documentation/literature-research-protocol/