MedTech Europe report on Administrative Burden under In Vitro Diagnostics Regulation and Medical Devices Regulation

A key goal of the European Commission is for Europe to have less reporting, less bureaucracy, and more trust, better enforcement and faster permitting. It is important to have a clear understanding where and how the bureaucracy can be reduced while maintaining the goals of the European regulations for medical devices (MDs) and in vitro diagnostic medical devices (IVDs). ​

MedTech Europe has prepared a Report on Administrative Burden to contribute to the European Commission’s Targeted Evaluation of Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). The Targeted Evaluation aims to assess whether the rules and their implementation are effective, efficient and proportionate. ​

MedTech Europe’s Report provides an analysis and compilation of the main sources of administrative burden under IVDR and MDR that have little added value and/or are very inefficient in achieving regulatory compliance as compared to required effort and costs. It provides:​

• The main sources of administrative burden under IVDR or MDR from a manufacturer’s perspective in IVD Performance Evaluation, MD Clinical Evaluation and Clinical Investigation, Notified Body assessment, Post-Market Surveillance, European database on medical devices (EUDAMED), European Medical Device Nomenclature (EMDN), Economic Operators requirements and Digitalisation.
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• Justification as to why these administrative burdens should be considered unnecessary or inefficient in achieving regulatory compliance with provided data and/or examples, where available.
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• Strategies where the burden could be simplified by streamlining administrative processes or improving/eliminating requirements and practices that have little to no added value to help businesses and citizens to comply with EU legislation or national obligations and achieve regulatory compliance. ​

You can find the summary document and the full report on Administrative Burden under IVDR and MDR below.