OBJECTIVES: With tightening health system budgets, medical devices (MDs) are being increasingly scrutinized for their impact on overall healthcare cost. The evidence bar for implantable MDs is particular high since most implantable devices are not reimbursed separately by payers, but via direct bundled payments to the provider. To characterize that trend, the objectives of this study were to: 1)      Identify specific evidence criteria that maximally impact the payer decision, 2)      Note differences in HTAs across global markets,  and finally 3)      Outline differences in evidence requirements between drugs and devices.    METHODS: A multimarket review of implantable MD HTAs and reimbursement decisions published from 2008-2013 was conducted. Identified by HTA Watch, HTAs included those from Australia, Belgium, Canada, France, Germany, Italy, the UK and the US.  They spanned a variety of indications, including cardiovascular, orthopedic, neurological, trauma, among others. HTAs and reimbursement decisions were characterized for clinical and economic evidence requirements and apparent correlations and/or impacts on ultimate agency recommendation.  RESULTS: Evidence criteria evaluated by HTA agencies and payers primarily included: 1) Availability of supportive randomized controlled trials (RCTs), 2) Safety, 3) Efficacy/long-term outcomes, 4) Cost/cost-offsets/budget impact, and 5) Quality of-life improvement. In contrast to drug HTAs, clinician training and learning curve effects were often evaluated. Importantly, agencies recognized the challenge in demonstrating statistically- and clinically-significant evidence of improvement in outcomes. As such, many MDs were recommended on a restricted basis to specific patient subpopulations or on a coverage based on continued evidence development. While requirements considered most critical were largely uniform across global markets, regional nuances impacted the ability to obtain favorable reimbursement of implantable devices.  CONCLUSIONS: Similar to drugs, MDs face rising hurdles in terms of demonstrating value, both clinical and economic. Optimal global market access for implantable MDs hinges on monitoring evolving evidentiary requirements and on carefully planning to collect evidence early in the developmental cycle.