Reflection of the Medical Device Regulation

Abstract

The MDR states the objectives of the law in the preface. There you will find, among other things, a consideration of small and medium-sized enterprises as well as high health protection and an innovative effect. Therefore, the question arises to what extent these goals have been achieved so far or can be achieved in the foreseeable future. To this end, a systematic literature review was conducted to present the perspectives of various stakeholders in the healthcare sector. Critical situations certainly arise for certain manufacturers, Notified Bodies and certain patient groups. The adopted extension of the transitional periods could be helpful but will not solve all problems.

Keywords

• medical device regulation
• socioeconomic impact