Clinical Evaluation Experts - Dunes Medical Writing

As we hunker down for the holiday season in some parts of the world, always be mindful that the Notified Body reviewers may not share the same holidays. Plan ahead for your absence! (Photo from Fairbanks, AK)

When you are addressing deficiencies in NB review of MDR clinical evaluation documents, it is of paramount importance to have had experience of similar deficiencies. For a small to medium sized businesses, this can be challenging. Rest assured, we at Dunes Medical Writing have experience working on MDR clinical evaluation for major manufacturers and can draw from our experience to guide you. Contact us for free initial consultation!

Update cycles are ramping up for MDR compliant clinical evaluation reports and associated documents. Are your MDR clinical evaluation processes as efficient as they can be? Here are some tips to streamline the process to maximize efficiency. 1. Organize your clinical data and store them securely. Whether your organization uses platforms like Distiller or simply Excel spreadsheets, it is of paramount importance to have the clinical data in a consistent format that can be passed along to the next update or the next evaluator. Avoid rework at as much as possible. Rework can also introduce discrepancies that can lead to deficiency or non-compliance! 2. Standardize interfacing with other workstreams (PMS, Risk Management, Labeling, etc.) to avoid confusion. Often times, delays in a project are caused by simple miscommunication between workstreams, e.g. IMDRF coding conventions for risk idenfication. These interfaces should be as clear and consistent as possible to avoid inefficiency. 3. Request information as early as possible. Information hunting is the bane of our existence. All required information should be requested at the beginning of the project and if information is yet to be available, the responsible SME should be made aware of the request early on still. Happy Updating!

5 Red Flags of a Bad Clinical Evaluation Consultant 1. They say they know it all. Seasoned veterans like to make sure what they say is correct and do not jump to an answer right away. 2. They say you need to do everything and right away. They do not provide strategic plans to tackle issues with the scope and budget in mind. 3. They do not respect your expertise. They trample your knowledge and experience and dictate their way. 4. They only try to cover their ass. Instead of working WITH you, they work against you to avoid liability. 5. They show no interest of following up after the work is done. They do not back up their work by following up to ensure the work done was satisfactory.

5 Red Flags of a Bad Clinical Evaluation Consultant 1. They say they know it all. Seasoned veterans like to make sure what they say is correct and do not jump to an answer right away. 2. They say you need to do everything and right away. They do not provide strategic plans to tackle issues with the scope and budget in mind. 3. They do not respect your expertise. They trample your knowledge and experience and dictate their way. 4. They only try to cover their ass. Instead of working WITH you, they work against you to avoid liability. 5. They show no interest of following up after the work is done. They do not back up their work by following up to ensure the work done was satisfactory.

European Parliament Plenary released a petition to spotlight "Urgent need to revise the medical devices regulation" (see the link below). It is great to see that the parliament is seeing what we already see! Hope this leads to some meaningful actions that actually help the small to medium sized enterprises ("SMEs" per document). The key takeaways are: - The European Parliament urges the European Commission to address implementation challenges and revise critical articles in the MDR and IVDR by early 2025. - The current regulatory framework has created certification delays and increased burdens on small and medium-sized enterprises (SMEs), hindering market access for innovative devices. - There are concerns about device shortages due to regulatory delays, especially in essential medical and in vitro diagnostic devices. - The petition highlights the need for streamlined procedures for devices serving small or specialized markets, like pediatric and rare disease devices, to ensure availability and affordability.(Orphan devices) - The full launch of EUDAMED is emphasized as a priority for improving device transparency, availability, and coordination across EU Member States. See for yourself: https://lnkd.in/g6UQyAja Text Adopted: https://lnkd.in/dJj2vg7Z #EU #MDR #parliament

Medical Device Coordination Group (MDCG) 2021-25 Rev. 1 is released today. It offers updated guidance on the application of the Medical Devices Regulation (MDR) to legacy devices and those placed on the market before May 26, 2021, in accordance with earlier directives (90/385/EEC or 93/42/EEC). It incorporates amendments from Regulation (EU) 2023/607, which extended the transitional period for certain devices to either December 31, 2027, or December 31, 2028, depending on device risk class. Key Points Relevant to Clinical Evaluation: Clinical Evaluation for Legacy Devices: While full compliance with clinical evaluation requirements (Article 61, Annex XIV of MDR) is not mandatory during the transitional period, manufacturers should prepare to meet these obligations for legacy devices during the transition. Quality Management System (QMS): From May 26, 2024, legacy device manufacturers must implement a QMS in line with Article 10(9) of the MDR. However, this QMS need not be fully certified for clinical evaluation until full MDR compliance is achieved. Post-Market Surveillance (PMS): Legacy devices must comply with MDR requirements for PMS, including the reporting of serious incidents, field safety corrective actions (FSCA), trend reporting, and preparation of PMS plans (Articles 83-86). Vigilance and Market Surveillance: Provisions under Articles 87-100 of the MDR apply to legacy devices, ensuring ongoing oversight and responsiveness to safety concerns, including the analysis and reporting of incidents and corrective actions.

Medical Device Coordination Group (MDCG) 2021-25 Rev. 1 is released today. It offers updated guidance on the application of the Medical Devices Regulation (MDR) to legacy devices and those placed on the market before May 26, 2021, in accordance with earlier directives (90/385/EEC or 93/42/EEC). It incorporates amendments from Regulation (EU) 2023/607, which extended the transitional period for certain devices to either December 31, 2027, or December 31, 2028, depending on device risk class. Key Points Relevant to Clinical Evaluation: Clinical Evaluation for Legacy Devices: While full compliance with clinical evaluation requirements (Article 61, Annex XIV of MDR) is not mandatory during the transitional period, manufacturers should prepare to meet these obligations for legacy devices during the transition. Quality Management System (QMS): From May 26, 2024, legacy device manufacturers must implement a QMS in line with Article 10(9) of the MDR. However, this QMS need not be fully certified for clinical evaluation until full MDR compliance is achieved. Post-Market Surveillance (PMS): Legacy devices must comply with MDR requirements for PMS, including the reporting of serious incidents, field safety corrective actions (FSCA), trend reporting, and preparation of PMS plans (Articles 83-86). Vigilance and Market Surveillance: Provisions under Articles 87-100 of the MDR apply to legacy devices, ensuring ongoing oversight and responsiveness to safety concerns, including the analysis and reporting of incidents and corrective actions.

This summary examines the interpretation of Real-World Evidence (RWE) and its growing significance in healthcare decision-making, regulatory submissions, and policy development. RWE offers valuable insights into patient outcomes across diverse populations and clinical settings, making it a crucial complement to traditional clinical trials. Key methodologies for interpreting RWE include multivariable analysis and propensity score matching, which control for confounding factors and biases inherent in observational studies. Statistical tools like odds ratios and hazard ratios help quantify associations between treatments and outcomes, enhancing the reliability of results. However, RWE presents challenges, such as data heterogeneity, missing information, and the need to balance generalizability. #MDR #clinicalevaluation #RWE #RWD

Do you want to use real-world evidence (RWE) for clinical evaluation? Read our series on RWE! #4 is on data analysis. #RWE #mdr #clinicalevaluation