Loading...
TextEngine
Theme & topic descriptions
| A | Regulatory Challenges and Market Access for Medic… | The challenges faced by medical device manufacturers in navigating the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), including high compliance costs, stifled innovation, and market access issues. This encompasses the impact on SMEs, disproportionate requirements for low-risk devices, and the need for predictable and transparent regulatory frameworks. |
| 1 | Support for SMEs | Strategies to facilitate market access for small and medium-sized enterprises, including simplified guides and financial assistance. |
| 2 | Impact on Market Access | The negative consequences of regulatory requirements on the availability of medical devices in the market, affecting patient access to necessary treatments. |
| 3 | Impact of Notified Bodies | The role and limitations of Notified Bodies in the certification process, including delays and increased costs for SMEs. |
| 4 | Barriers to Market Entry | The obstacles that the current MDR implementation poses for small and medium-sized enterprises, affecting their ability to innovate and compete. |
| 5 | Concerns about Clinical Evaluation | Issues related to the unrealistic requirements for clinical evaluations and the lack of transparency in competitor information. |
| 6 | Cost Implications of MDR | The high costs associated with compliance to the Medical Device Regulation (MDR) are unsustainable for many manufacturers, particularly small and medium-sized enterprises, potentially leading to market exits. |
| 7 | Global Market Access | Challenges faced by companies in aligning EU regulations with international standards, impacting their ability to compete globally. |
| 8 | Regulatory Burden | The challenges and complexities faced by companies in complying with medical device regulations, including high costs and lengthy processes. |
| 9 | Innovation Challenges | The stringent requirements of the MDR are stifling innovation in the medical device sector, making it difficult for new and improved products to reach the market. |
| 10 | Impact on Patient Care | The negative consequences of regulatory burdens on the availability and affordability of medical devices, ultimately affecting patient choice and care. |
| 11 | Disparity in Market Conditions | The regulatory environment creates unequal competitive conditions between European and non-European companies, disadvantaging local manufacturers. |
| 12 | Inequality in Regulation Enforcement | Variability in how regulations are enforced across different member states leads to unequal treatment and compliance challenges for manufacturers. |
| 13 | Implementation Challenges of IVDR | Issues related to the practical implementation of IVDR, particularly for laboratory-developed tests (LDTs) and orphan diagnostics, leading to potential market withdrawal of important products. |
| 14 | Regulatory Delays | The significant delays in the implementation of regulations and the slow response from regulatory bodies, impacting manufacturers' ability to comply and innovate. |
| 15 | Legacy Device Regulation | The application of MDR to legacy devices is viewed as excessive and costly, impacting their market presence and development. |
| 16 | Need for Tailored Guidance | The necessity for specific and clear guidance for different categories of medical devices to facilitate compliance and innovation. |
| 17 | Regulatory Transparency | The importance of transparency in regulatory processes, including timely communication and collaboration between manufacturers and notified bodies. |
| 18 | Regulatory Objectives and Effectiveness | Concerns regarding the effectiveness of MDR/IVDR objectives in ensuring safety, innovation, and market access for manufacturers. |
| 19 | Market Access Predictability | Manufacturers require a more predictable framework regarding timing and costs for market access. |
| 20 | Regulatory Interpretation Challenges | Manufacturers face excessive and often unnecessary interpretations of regulations, leading to increased costs and market exits for SMEs. |
| 21 | Disproportionate Regulatory Requirements | The regulatory requirements under MDR and IVDR are seen as excessive for low-risk devices, negatively impacting innovation and competitiveness, especially for small manufacturers. |
| B | Environmental and Ethical Considerations in Medic… | The environmental impact of medical device regulations, particularly the contradiction between paper-based instructions and environmental sustainability, and the ethical aspects of clinical investigations, including the informed consent process. |
| 22 | Environmental Concerns in Regulation | The contradiction between regulatory requirements for paper instructions and the push for reduced carbon footprints highlights environmental concerns in the medical device industry. |
| 23 | Informed Consent Process | The importance of clear, accessible, and ethical informed consent in clinical investigations, ensuring participants understand risks and benefits. |
| C | Other topics | Topics which could not be grouped into themes. |
| 24 | Dental Market Regulation | The need for improved regulation in the dental market to ensure safety and accountability among practitioners and manufacturers. |