New Medical Device Regulations ahead – What does that mean for Arthroplasty Registers?

Open Access This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the source is credited. DOI 10.3109/17453674.2014.1002185 Background Against the background of several major adverse incidents involving orthopedic implants, such as the Articular Surface Replacement (ASR) hip arthroplasty, the European Union (EU) Commission and the US Food and Drug Administration have addressed the issue of component safety and post-market surveillance. The aim is to improve the quality of care and patient safety (Sedrakyan 2012a, b). The regular procedures of CE approval and market monitoring and also the basic data used for these processes—for the most part derived from clinical and experimental studies—were unable to ensure sufficient patient safety and prevent adverse events (Godlee 2011). The EU therefore intends to recast the Medical Device Directive, which forms the basis for national medical device legislation (Medical Device Directive, last amended in September 2007). One of the main reasons for the deficiencies in identifying inferior products is the difference in methodological requirements between pharmaceutical and medical devices regarding clinical studies, which serve as a basis for decisions. At present, the regulatory processes do not adequately consider fundamental differences between orthopedic implants and drugs, such as limitations in randomization and blinding during surgical interventions, or the often long time until implant failure (Curfman and Redberg 2011). The validity of clinical cohort studies concerning medical devices is limited and includes a high risk of misinterpretation (Labek et al. 2011a, b). We argue that comprehensive data collection by means of high-quality registries can make a substantial contribution to solving this serious issue that physicians and other decisionmakers in the public health system are facing.