MedTech Europe response to the consultation on Targeted Evaluation of In Vitro Diagnostic Regulation and Medical Devices Regulation

MedTech Europe has submitted its response to the consultation on the targeted evaluation of the In Vitro Diagnostic Regulation (IVDR) and the Medical Devices Regulation (MDR). As a leading industry association, MedTech Europe advocates for a regulatory framework that ensures medical device safety while fostering innovation.

In its response, MedTech Europe provides valuable insights and recommendations for improving the current regulatory landscape. The response emphasises the need for practical and balanced approaches that support industry sustainability and facilitate patient access to medical technologies. Key points of the response include:

• Enhancing clarity and consistency in the application of the regulations.
• Addressing challenges stemming from administrative burden.
• Making the change notification process clearer and more efficient.
• Streamlining conformity assessments.
• Optimising post-market surveillance and reporting.
• Improving alignment between the IVDR and MDR for a more coherent regulatory approach.
• Promoting European CE-marking as the point of reliance internationally.
• Calling for a unified, accountable governance structure to improve system oversight and resource allocation.

Read our full submission below.