Until recently, the Medical Device Directive (MDD) 93/42/EEC (1993) and the Active Implantable Medical Device Directive (AIMDD) 90/385/EEC (1990) made up the European Union’s regulatory model governing medical devices. However, the medical devices sector has vastly developed over the past 20 years, and these Directives have now been replaced by the Medical Device Regulation (MDR) 2017/745 (2021). Already under fire for their shortcomings in enforcing quality and safety standards, part of the impetus for replacing the old regulations was a scandal involving breast implants made by the company Poly Implant Prostheses (PIP). A lack of safeguards imposed by PIP resulted in severe injuries and deaths when the implants failed. The repercussions of these malpractice cases spanned nearly 20 years and included criminal investigations, product recalls, bankruptcy, and reprisals given the toothlessness of the prevailing legislation. Framed by this saga, this chapter examines responses by the medical device industry to the new regulations, analyzing how this stance came to be through the corporation’s own motivations. A series of Nielson-Parker models map these corporate responses to the new framework revealing how this clash between the medical devices industry and the EU ultimately conciliated a balance capable of achieving both their goals—at least to some extent. For the manufacturers, these goals centered around economic interests while, for the regulators, the imperative was to ensure increased product safety going forward.