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Requirements for medical products: An in-depth look

Medical products are essential healthcare tools, ranging from simple bandages to complex implantable devices. Their importance in the diagnosis, treatment and prevention of disease makes it essential that these devices are effective and safe. That's why there are strict regulations to ensure that only high-quality products are used.

In this blog post, we examine in detail the requirements that medical device manufacturers must meet before their products find their way into hospitals and doctor's offices. This also takes a brief look at our work in medical design and the hurdles it brings with it.

Medical device requirements: Classification

Classification is a first and crucial step with regard to the legal requirements of medical devices. The classification helps to determine which specific requirements apply to a medical device. In the European Union, for example, classification is separated into classes I, IIa, IIb and III based on the potential risk posed by the product:

Class I: Products with the lowest risk, such as non-invasive instruments.
Class IIa and IIb: Medium risk, which is present, for example, in surgical instruments and some diagnostic devices.
Class III: High-risk devices, such as pacemakers and other implantable devices.

Classification not only influences the type of review required, but also the degree of scrutiny by regulators. Classification is particularly important for companies in the field of medical technology design, in order to incorporate the requirements for medical devices into the development process.

Medical device requirements: Conformity assessment

After classification, manufacturers must demonstrate through the conformity assessment procedure that their medical devices meet the applicable requirements. This procedure varies depending on the risk class of the product:

Class I: A self-declaration by the manufacturer is often sufficient, although certain documents must be submitted to the authority responsible.
Class IIa and IIb: Typically requires more detailed testing and certification by a notified body.
Class III: Subject to the most rigorous testing, including detailed clinical studies and periodic reviews.

The conformity assessment also includes checking the technical documentation and the manufacturer's quality management system.

Medical device requirements: Clinical assessment

Clinical evaluation is a central pillar in the approval process for medical devices. It serves to provide comprehensive evidence that a medical device not only works and meets the objective requirements, but is also safe for its intended medical use. This assessment must include scientifically sound data obtained through clinical trials and other research methods. For products in higher risk classes such as IIb and III, extensive clinical studies are usually required, which are often multinational in nature in order to create a broad database.

These studies must be conducted according to strict scientific and ethical standards to meet medical device requirements. Their goal is to not only confirm the effectiveness of the product, but also document possible side effects and risks. The transparency and traceability of the study results are essential for them to be recognized by regulatory authorities such as the FDA in the USA or the BfArM in Germany. Another important aspect is the long-term monitoring of patient safety, which continues even after the product is launched on the market.

The documentation created during the clinical evaluation must cover all phases of product development, from the concept phase to the final product. It should contain detailed information on the methodology of the studies, the statistical analyses, the results obtained and the conclusions drawn from them. This comprehensive documentation is the basis for the approval of the product and plays a crucial role in compliance with the requirements for medical devices during subsequent market surveillance.

Medical device requirements: Quality management system

As an experienced service provider for industrial design in Hamburg, we know the importance of the quality management system (QMS) to ensure that medical products meet their requirements. An effective QMS covers all areas of product development, production, final inspection and market launch. The ISO 13485 standard defines the specific requirements for a QMS aimed at medical devices. This includes design and development, procurement, production processes, quality control and customer service activities.

Within the QMS, manufacturers of medical devices must document procedural instructions and process descriptions that ensure compliance with the required quality assurance measures. This also includes training employees to ensure that everyone involved understands the requirements for medical devices and their importance. Regular internal and external audits are required to verify compliance with QMS standards and promote continuous improvement.

Medical device requirements: labeling and documentation

The correct labeling and comprehensive documentation of a medical device are crucial to ensure its safe and effective use. Every product must be provided with information that informs the user about the correct use, the limits of use and possible risks. The EU Medical Device Regulation (MDR) requires that all medical devices bear a CE marking, indicating that the product complies with EU directives.

The accompanying documentation must contain detailed instructions for use, information on maintenance and disposal of the product, as well as data on clinical effectiveness and tested safety features. These documents must be easy to understand for users and accessible at all times. Compliance with these regulations is regularly checked by the responsible authorities and is an obligatory requirement for medical devices.

Medical device requirements: Post-market surveillance

Post-market surveillance (PMS), is an ongoing process aimed at monitoring the long-term safety and effectiveness of medical devices. This process is particularly important because some problems may not become apparent until the product is widely used. Manufacturers must implement systems to systematically collect and evaluate feedback from users. This includes reports of adverse events, device failures, and other safety-related information and is an ongoing requirement for medical devices.

PMS helps manufacturers make necessary adjustments to products, whether through modifications in design, improvements in manufacturing or updates to the instructions for use. The results of post-market surveillance must be regularly reported to regulatory authorities and can be used to update the risk assessment and further develop the clinical evaluation. This ensures that medical devices continue to meet the highest safety and performance standards even after they are released onto the market.

Understanding and mastering the requirements for medical devices

The regulatory requirements for medical devices are extensive and complex, but they are critical to ensuring the safety and effectiveness of these vital healthcare tools. Manufacturers must carefully comply with these regulations to not only meet legal requirements for medical devices, but also to gain and maintain the trust of users and patients. In an ever-evolving medical environment, these regulations are essential to ensure the integrity and performance of medical devices.

If you have any further questions on the subject of “requirements for medical devices”, please feel free to contact us at any time. We look forward to your inquiry and will not only support you with general admissions questions, but can also actively participate in the admissions processes, including conducting formative evaluations.