The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) represents a significant regulatory shift in the European Union’s (EU) approach to medical device oversight. The MDD, which was the previous regulatory framework, focused primarily on ensuring the safety and performance of medical devices, whereas the MDR places a stronger emphasis on patient safety and public health. MediPhorum’s EU MDR (article 117) workstream aims to generate an industry-wide consensus approach for incorporating Article 117 into the device development process.

A significant shift in medical device oversight and excessive regulatory burden

EU MDR Article 117 has been mandatory since May 2021, but there is still no clear industry consensus regarding application to drug delivery devices,
Ambiguities also exist regarding requirements e.g., Notified Body Opinion, GSPRs and Human Factor Study requirements
Excessive regulatory burden for delivery device development and potential risks to product approval.
Detailed device development plans cannot be established, leading to delays in registering for market

Right-first-time submission

Developing an industry consensus approach for incorporating Article 117 into development processes
Clarifying regulatory compliance requirements e.g., new/ revised outputs as part of the design control process to satisfy the requirements of Article 117.

Reduced workload when preparing for a request for notified body opinion (NBOp)
Improved ‘right-first-time’ submission
Enabling NBs to provide clear timelines

EU MDR deliverables


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

31 January, 2022
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