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Implementation of Article 117 of European Union Medical Devices Regulation General Safety and Performance Requirements: A MediPhorum opinion report: 2023 update

3 June 2024
MediPhorum Drug Delivery
Implementation of Article 117 of European Union Medical Devices Regulation General Safety and Performance Requirements: A MediPhorum opinion report: 2023 update
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Across the European Medical Device Regulation (EU MDR), adhering to General Safety and Performance Requirements (GSPRs) forms the cornerstone of compliance. Manufacturers face the challenge of addressing significant changes to a product that already has a Notified Body Opinion, conformity testing, and nuanced aspects like biocompatibility and human factors validation for new Single Integral Drug-Device Combination Products.

The submission of reports to Notified Bodies (NBs) for opinion introduces additional validation challenges, while discrepancies in approaches among NBs and EU competent authorities further underscore the complexities.

This paper reviews these challenges and how the selection of an NB introduces its own set of complexities, with the need to navigate processes and criteria. This includes considering NB timelines and the potential utilization of fast-track options to expedite assessments. Navigating the submission for Notified Body Opinions within EU MDR Article 117 brings insights into risk management, information sharing, platform approaches, and the inconsistency of NB reviews across different instances.

This paper also discusses how the registration of complex devices adds a layer of difficulty, requiring meticulous attention to detail and compliance with the regulatory framework.

EU MDR Article 117 demands a comprehensive approach to compliance, addressing GSPRs, significant changes, labelling requirements, and engagement with regulatory bodies. Manufacturers must strategically navigate these challenges to ensure adherence, bringing their innovative and complex devices to market in alignment with regulatory expectations.

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