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Upcoming Changes to ISO 14155:2020ISO 14155:2020, the international standard for the clinical investigation of medical devices for human subjects, is undergoing significant updates. These changes are designed to enhance risk management, clarify procedures and ensure the safety and efficacy of clinical trials.

Here’s a summary of the key updates:

Risk Management Updates:

1. Risks related to investigational devices (6.2.1)

• New considerations focus on the specific risks associated with using the investigational device itself. These include adjustments in risk acceptability criteria based on the study population proportion and the updated risk management flow both before and after the start of the study.

2. Risks related to clinical investigations (6.2.2)

• This section now includes risks associated with procedures required by the Clinical Investigation Plan (CIP) that fall outside standard care. A new section (7.4.5) mandates a risk-based approach to managing these additional clinical procedures, advising sponsors to consider suspending or terminating the study if unacceptable risks arise.

Adverse Event (AE) Categorization
Annex F has been updated to improve the categorization of adverse events (AEs). This includes clear criteria for identifying and classifying serious adverse device effects (SADE), anticipated SADEs, and non-device-related AEs. The flowchart in Annex F has been revised to provide more precise guidance on the categorization process.

Estimands Framework
A new Annex K introduces the concept of “estimands” for clinical investigation design. An estimand is a precise description of the treatment effect that reflects the clinical question posed by the investigation’s objective. This framework helps in aligning the statistical analysis with the clinical objectives, considering factors such as treatment conditions, target population, endpoints, intercurrent events and methods for handling missing data.

Informed Consent
Updates to sections 5.8.1 and 5.8.2 emphasize the importance of obtaining written informed consent from subjects or their legally designated representatives before any clinical investigation procedures are applied. The process must be thoroughly documented, and any special circumstances must be clearly described.

Investigator Brochure
The information required in the Investigator Brochure has been expanded, ensuring comprehensive details about the investigational device are provided. This includes all relevant technical, functional, and clinical performance characteristics.

Under the Medical Device Regulation (MDR) 2017/745, the process of clinical evaluation is crucial for demonstrating the safety and performance of medical devices. Qmed’s article likely emphasises the significance of evaluating these aspects and outlines methods to identify and validate safety, performance, and clinical benefits for a particular medical product. Qmed has written an article with the focus on: 1. Importance of Identifying Safety, Performance, and Clinical Benefits. 2. Methods to Identify and Validate Safety, Performance, and Clinical Benefits. 3. How to determining Analytic Methods to Collect Data. Overall, the process of clinical evaluation necessitates a comprehensive approach that involves careful assessment, data collection, analysis, and continuous monitoring to ensure the safety, performance, and clinical benefits of medical devices in compliance with the MDR 2017/745. Hope you enjoy and reach out if you need support to navigate the process!

The development and manufacture of medical devices require stringent design control processes to ensure their safety, effectiveness, and compliance with regulatory standards. This white paper provides an in-depth examination of medical design control processes, with a particular focus on the International Organization for Standardization (ISO) 13485 standard, other relevant standards and the Medical Device Regulation (MDR). The paper discusses key concepts, stages, and activities involved in design control, along with the regulatory requirements imposed by the standards and the MDR. By adhering to these standards, medical device manufacturers can streamline their design processes and enhance patient safety and product quality.

The year 2023 has come with changes to Qmed! Please help me welcome Agnes Friese Skov as newly announced General Manager for Qmed. At Qmed we are at a journey. The focus is on Qmed clients and the team. Supporting and strengthening the competences and culture Agnes will focus on the well-being of our employees, on our core values and on maintaining a good work culture. I will continue using my experience and know-how to support Qmed existing and future coming customers, and help companies make the right strategic choices for their products in development. With the organisational changes we will support the coming years growth. Thanks Helene

Our newest article is a result of an interview by Helene Quie to Bassil Akra, AKRA TEAM’s CEO, on the subject of Clinical Evaluations.

Our newest article is a result of an interview by Helene Quie to Søren Underbjerg, Qmed Consulting’s Team Lead for Clinical Development and Market Access, on “The Use Scientific Surveys as a Method to Collect Medical Device Clinical Evidence”.