Evaluating the Implementation and Results of EU 2017/745

Detta är en Master-uppsats från KTH/Medicinteknik och hälsosystem

Sammanfattning: The new regulation on medical devices, EU 2017/745, came into force in May 2021 meaning that all economic operators in the industry need to adhere to new, stricter requirements. As there is yet no common practice on how to implement and comply with the new requirements, many struggles with this.  In this thesis, the implementation of a distributor company operating in the medical device industry, currently in the middle of the implementation, is qualitatively evaluated to identify areas of improvement. This is done by conducting a case study where the company's implementation approach is mapped and evaluated with regard to good practice, and implemented organizational changes due to the regulation are identified and benchmarked against similar companies. Their interpretation and implementation appear to be rather strict and ambitious based on the overviewing benchmark with similar distributors. Their implementation moreover largely followed good practice, but several areas of improvement could nevertheless be identified.  Additionally, this thesis aimed to explore how the result of the final implementation of EU 2017/745 can be assessed. A literature review was conducted where general parameters to assess regulatory implementation were identified, followed by a literature review where it was investigated how these parameters can be adapted to assess the result of the implementation of EU 2017/745. Several parameters of interest to assess the result were identified together with examples of indicators that can be used. More research is however needed to be able to establish a complete, adequate method to assess the final implementation result.

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