OBJECTIVES:  Medical devices (MDs) must comply with the EU directives and be CE marked before entering the European market. Despite these high requirements, several serious health risks have been observed during the past years, which were initiated by implanted MDs. These incidents have caused the European Commission to revise the Medical Device Directives (MDD). The implementation of the new MDD will affect the stakeholders like manufacturers, regulatory bodies, physicians, and patients in Europe as well as in the US. Aim of this work was to assess the consequences of the new MDD with regard to the stakeholders and to estimate their potential occurrence rate. METHODS:  A SWOT analysis has been performed to identify the strengths, weaknesses, opportunities and threats of the new MDD followed by a risk analysis. RESULTS:  The SWOT analysis revealed two types of consequences of the new MDD: Immediate consequences that are associated with a high probability of occurrence like an increased workload and higher product development costs for manufactures, improved product safety for patients, enhanced pool of medical evidence for regulatory bodies and physicians. Potential indirect consequences of the new MDD, which are less likely or even unlikely, are consequences regarding a delayed market access of new products, a higher co-payment for patients using MDs, a discrimination of diseases with a low prevalence as well as a negative impact on the development of innovative products. CONCLUSIONS:  For US and European stakeholders the implementation of the new MDD will result in a benefit, especially for patients and regulatory bodies. Nevertheless, an extended regulation may also cause unfavorable consequences. Therefore, and even though the implementation of the new rule will take a few years, it is important that manufacturer anticipate hidden consequences as early as possible. Therefore, the findings of the SWOT analysis are the basis for the development of strategic scenarios.