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Objectives: Understanding whether the regulatory framework in the European Union creates different standards for medical devices and drugs, assessing whether there is evidence on the impact of those standards on clinical and HTA research, and reflecting on findings in order to propose legislative changes for promoting a more efficient allocation of resources in the healthcare systems., Methods: Reviewing and comparing the legal framework for the approval of medical devices and drugs in the EU, with a particular focus on the changes brought by Regulation (EU) 2017/745. Investigating the available information on manufacturer sponsored clinical studies and HTA-supported recommendations for medical devices and drugs., Results: The review of the legislation identified different standards for approval of devices and drugs on their quality, safety, and performance/efficacy dimensions and fewer manufacturer sponsored clinical studies and HTA-supported recommendations for medical devices versus drugs., Conclusions: Policy changes could be implemented in order to promote an integrated evidence-based assessment system for a better allocation of resources in healthcare, namely: a consensual classification of medical devices from an HTA perspective, which could be used as a guide for generating outcomes in clinical investigation, and the adoption of conditional coverage practices including mandatory post-approval evidence development for performing periodic technology assessments., (© 2023 The Authors. The International Journal of Health Planning and Management published by John Wiley & Sons Ltd.)

Background: Working donkeys represent an important source of energy worldwide. Poor working conditions and equipment affect their ability to work. Poorly designed, ill-fitted harness causes inefficient transfer of power and leads to health and welfare issues. Using technology to assess different types of collars provides a better understanding of those that are most efficient for working donkeys., Materials and Methods: Seven different collars were tested using pressure pads. Contact area, median, maximum and peak pressures were obtained for the whole collar and critical points. Eight donkeys pulled 20% and 40% of their body weight, using each collar, under controlled conditions., Results: Contact area and pressures vary between collars and effort, with design and expansion capacity of the collars playing a major role. Simple collars designed specifically for donkeys performed well, with full collars designed for horses also having good results. Due to reduced expansion capacity and contact in the critical points, the breast collars were the least effective., Conclusion: Design, appropriate padding and manufacturing materials and adjustment capacity are key features for good collars, and such parameters are of paramount importance in terms of health and welfare for working donkeys., (© 2021 British Veterinary Association.)