New European Medical Device Directive (MDD) Comes Into Effect In 2020: Chances And Consequences For Stakeholders

Abstract

Despite high requirements for approval of medical devices (MDs), several serious and avoidable complications caused by product specific quality deficiencies were observed during the past years. To ensure that all MDs (all classes ranging from heart valves to sticking plasters) are safe, the EU commission proposed in 2012 new regulations on medical and in-vitro diagnostic MDs (e.g. extending the market surveillance, verifying scientific and technological evidence). To assess the effect of the new MDD on four different stakeholders (i.e. manufacturers, regulatory bodies, physicians, and patients) a decision analytical framework has been used. Based on a structured analysis the strengths, weaknesses, opportunities and threats of the new MDD have been identified and a qualitative analysis of their occurrence rates was performed. The most often expected consequences by implementing the new MDD are the increased workload and higher product development costs for manufactures, but also an enhanced product safety for patients, higher quality of medical evidence to the attention of regulatory bodies and physicians. Outcomes occurring less often as a consequence of the implementation of the new MDD are a decline of new and innovative products for diseases with a limited profitability or a reduction of small and mid-size manufacturers of MDs either due to buy up by bigger companies or by abandoning the business area. Overall, the implementation of the new MDD results in a benefit for all stakeholders. Nevertheless, an extended regulation causes also unfavorable consequences. Even though the implementation of the new rule will come into effect in 2020, it is important that all stakeholders anticipate the wide range of potential consequences as early as possible. Therefore, the findings of the decision analytical framework may help to identify areas with a high impact and to develop strategic decisions.