The biomedical industry is an industry where product safety must be as good as possible in order to ensure the best possible patient safety. A recall of a biomedical product is a disaster for all involved, especially for the patients concerned.

In the case of orthopaedic implants, there are fortunately a number of international standards (ASTM and ISO) that define minimum safety criteria that these implants must meet. These standards are extremely valuable and useful, but they do not cover all aspects necessary for good product safety, as some standards do not have minimum acceptance criteria. Furthermore, for some standards, the in vitro / in vivo suitability is not established. This presentation will show what approaches are possible to minimise the risks in such a case.

The new European MDR regulation gives criteria for the clinical studies needed to obtain the CE mark for the marketing of these implants. Unfortunately, these criteria are not clear and are subject to interpretation. This presentation will highlight the ambivalence of these criteria and show what the solutions are to offer products that are as safe as possible.

The third part of this presentation concerns the post-marketing surveillance of biomedical products and demonstrates that such surveillance is absolutely primordial to ensure the safety of these products.