The EU 2017/745 new Medical Device Regulation was approved by the European Parliament. On May 5, 2017, the new Regulation (EU) 2017/745 was issued, and on May 25, 2021 onwards it went into effect. It highlights how improving performance, safety, and transparency requires clinical evidence. It still requires work to bring devices into compliance with EU-MDR, even with the present guidelines and long transition periods. Clinical evidence that considers the clinical, analytical, and scientific elements of safety and efficacy for each unique indication under normal use is essential to demonstrate conformity with the EU-MDR. Manufacturers are required to provide more thorough validation, scientific backing, and clinical performance studies to substantiate the efficacy and safety of their product. Consequently, guidance on providing this clinical evidence is essential for both end users in health care institutions and manufacturers of medical devices.
The MDR/ISO 14155 standard defines a clinical investigation as any systematic study that involves one or more human subjects and is conducted to evaluate the effectiveness or safety of a device.
Investigations using medical devices that are intended to answer important scientific questions are known as clinical studies. Strict scientific guidelines, like ISO 14155, must be followed in order to protect people and produce reliable scientific results. Clinical trials that use medical devices are not always clinical studies, but they also don’t aim to perform a systematic research with one or more human subjects in order to assess the efficiency or safety of the device or devices being used. Clinical investigation, which is done to ascertain whether therapies are beneficial and ineffective for humans, is one of the final stages of a drawn-out and oftentimes tedious research and development process.
Prior to commencing, it is vital to comprehend that the terms “clinical investigation,” “clinical trial,” and “clinical study” are synonymous and align with the ISO 14155 standard.
Establishing and confirming clinical safety—the understanding of how to prevent and limit risks, mistakes, and harm to patients and personnel, including doctors and nurses—may be the aim of a clinical investigation. The cornerstone of all clinical research is providing ongoing improvements to treatment processes based on knowledge and learning from mistakes and adverse outcomes seen.
Furthermore, one of the objectives of a clinical trial may be to establish and validate the performance of a device. This involves figuring out whether a device can function as originally intended. Examining the device’s technical, functional, or even diagnostic aspects allows for this. Both the clinical benefit to patients and the manufacturer’s ability to achieve the intended purpose of the device must be verified. Examining the positive effects that a device can have on an individual’s health is known as clinical benefits, and demonstrating and validating these advantages is another goal. It is expressed in terms of an important and measurable patient-centered result. What’s more, ultimately, secondary effects are particularly significant while doing a clinical study. Finding beforehand unidentified unfavorable impacts and getting more data about existing secondary effects can be two of a clinical investigation’s objectives.
Finding the relevant literature typically requires a significant amount of time and may include reading through hundreds of publications, all of which must be evaluated, assessed, and summarized for a report known as a clinical evaluation report. Contingent upon the sort of device, this report might turn out to be incredibly point by point and 100 pages in length. It is suggested that the clinical evaluation report be refreshed throughout the device’s lifecycle.
Before being put on the market, medical devices may need to go through a clinical trial in the US and the EU. For some risk classes, a clinical study with human participants is required to evaluate the device’s safety and/or effectiveness.
- As per EU MDR, clinical studies are expected for all implanted devices classified as Class III and Class IIb in the EU.
Premarket approval (PMA) for all Class III devices in the United States is contingent upon clinical research conducted by the FDA.
EU MDR has 20 articles outlining the requirements for clinical investigations of medical devices, spanning articles 62 through 82. Within these articles, the regulation lays out three regulatory pathways manufacturers can take:
- Article 62 covers investigations that are performed in order to demonstrate conformity and obtain a CE marking. This is the pathway medical device companies will use if their device classification (for Class III or Class IIb implantables) requires a clinical investigation.
- Article 74(1) covers the regulatory pathway for devices that already have a CE marking if the parameters of the investigation are within the device’s intended purpose. In other words, if conducting a clinical investigation as part of Post-Market Clinical Follow-Up (PMCF), then Article 74(1) will guide.
- Article 82 covers clinical investigations that are not being performed in order to demonstrate conformity. Additionally, the Member State in which the study initiated may have relevant national provisions to follow.
The European Medical Device Regulation (2017/745) (MDR) sets important new requirements for pre- and post-marketing clinical investigations. Conducting a clinical investigation is one of the most time-consuming and resource-intensive activities a medical device manufacturer faces. For these reasons, manufacturers must ensure that the purpose of the clinical investigation is clear. All applicable regulations, common specifications (e.g. on device-specific requirements for clinical trials), international standards, European guidance documents and national guidance documents are identified; all persons participating in the study understand their roles and responsibilities; and the study is well organized and conducted according to appropriate quality management practices.