Implementation of Article 117 of European Union Medical Devices Regulation (EU MDR) General Safety and Performance Requirements: a position paper

The EU MDR Article 117 became legally binding and mandatory in May 2021, but there is no clear industry consensus regarding its application to integral drug delivery devices.

The regulation is particularly unclear in the cases of a device constituent part being classified as an invasive device, and whether all drug product-contacting components must conform to the requirements for invasive components. There are also ambiguities regarding requirements such as notified body opinions and human factor studies.

This paper aims to raise awareness of these issues and illustrates BioPhorum’s concerns. The main issues relate to:

  • Applying general safety and performance requirements
  • Risk management
  • Labeling requirements and instructions for use
  • Submission documents
  • Substantial change – post-approval
  • Classification
  • Notified body engagement.

It demonstrates how notified body submissions could lead to divergent outputs for similar products and is supported by case studies demonstrating some of the issues experienced.

Inconsistency when interpreting EU MDR General Safety and Performance Requirements creates an unnecessary administrative burden for manufacturers and notified bodies. The authors of this paper ask for clarification so that the notified body opinion application process, and the opinion itself, are as efficient as possible for all parties. Where misalignment exists, companies with more conservative approaches to notified body opinion requests may inadvertently set higher than necessary ‘standards’ that others may be later expected to follow.

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Implementation of Article 117 of EU MDR position paper January 2022.pdf
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