AKRA Team GmbH
Climate Impact & Sustainability Data (2024)
Reporting Period: 2024
Environmental Metrics
Climate Goals & Targets
Environmental Challenges
- Varying interpretations among reviewers and notified bodies regarding EU MDR implementation.
- Bottlenecks in the certification process.
- High scrutiny of clinical data for medical devices.
- Insufficient clinical data for legacy devices.
- Difficulties in defining key safety and performance endpoints.
- Discrepancies in expectations on clinical evidence between notified bodies.
- Limited number of publications on similar devices.
- Heterogeneity of study designs.
- Challenges in defining device lifetime and collecting PMCF data over the full lifetime.
- Inadequate methodologies for literature reviews.
- Concerns regarding study design and level of evidence.
- Shortages of medical devices for pediatric and rare diseases.
- Slow pace of innovation due to stringent regulations.
Mitigation Strategies
- Joint events at regulatory conferences and meetings to improve alignment between notified bodies.
- Alignment between team-NB members on clinical topics.
- Mandatory Clinical Evaluation Consultation Procedure.
- Development of a centralized system for technical documents, post-market surveillance, and regulatory updates.
- Prioritization of diligence and keeping in tune with evolving regulatory landscape.
- Issuing certificates with conditions to allow for continued market access for devices with limited clinical data.
- Production of guidance/pathways for orphan devices.
- Legislative changes to provide 6 months' notice before removing a device from the market.
- Use of AI for regulatory-compliant literature reviews to streamline and scale decision-making.
- Utilizing Real-World Evidence (RWE) to supplement premarket data and support post-market surveillance.