The Regulation of Medical Robotics in Europe – Corporate Compliance in Medical Technological Innovation

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 robotics and medical devices in general. However, medical technology has vastly developed and evolved over the past 20 years, and these Directives have now been replaced by the Medical Device Regulation (MDR) 2017/745 in 2021. The first directives had various shortcomings in enforcing quality and safety standards, and the catalyst for the European Union to revise the framework of the old regulations was a major scandal involving breast implants made by the company Poly Implant Prostheses (PIP). The lack of safeguards by the initial framework imposed by PIP resulted in severe injuries and deaths when the implants failed, which resulted in a multitude of lawsuits across the union, including criminal investigations, product recalls, and bankruptcy. Under the light of the PIP scandal and the new MDR framework, this thesis examines responses by the medical device industry to the new regulations, analysing how their stance came to be through the corporation’s own motivations. Particularly, an examination of the industry under the lens of the Nielson-Parker model, maps these corporate responses to the new framework and reveals the effectiveness between balancing the industry’s goals and realities and the EU’s goals with the introduction of the MDR. For the manufacturers, these goals centred mostly around economic interests, while, for the regulators, their focus was to ensure increased product safety going forward. Unfortunately, the current regulatory landscape in medical robotics, or for high-risk devices in general, is too overbearing in some regards, in both the pre- and post-market processes resulting in heavy delays and increasing costs. Thus, a better balance between safety and barriers to compliance needs to be struck in order for the regulation to reach its full potential. This thesis, by mapping out corporate reactions to the MDR, and through comparing it to other industries that have had recent regulatory interventions, aims to facilitate and employ regulatory design that is a more suitable intermediary between industry interests while also satisfying their regulatory aims.