This presentation will show how clinical investigations (CI) with medical devices obtain an approval issued by a Competent Authority. Timelines and procedures will be discussed, since they are a key challenge in the development of medical devices, which need clinical data, for example to obtain a CE-certification. Furthermore, future challenges such as coordinated assessment of CI applications and inspections under the MDR will be shown, giving insight in CIE-WG topics.
The importance is given due to dramatic change in the European legislation and the current struggle with its implementation for both, industry and authorities. A basic understanding of the processes and guidelines is crucial for a smooth and successful CI approval.
Since legal provisions are often presented without extensive explanation and interpretations diverge, attending this session allows a rare insight in how Competent Authorities act and see the new regulatory landscape. You will understand which topics are in the focus of current developments and can raise awareness where guidance is missing, to allow a joint effort to reach the aim of the MDR and increase patient safety.

The broadened scope of the EU MDR introduces an additional element of scrutiny to the conformity assessment procedure by Notified Bodies for medical devices that fall under the scope of Article 54 (1). This element is a clinical evaluation consultation procedure (CECP) conducted by an independent expert panel (MDR Article 106) under the involvement of the Commission.

Since the launch of the expert panels’ 215 notifications under Article 54(3) were sent by Notified Bodies between April 2021 and 30 June 2022. The CECP was applied to 24 of these devices (11,2%), whereby 87,5% of those were Class III implantable devices. Thus far the expert panel has provided an opinion for 8 devices.

The decisions to provide an opinion were based on initial concerns, mainly regarding a high level of device and procedure novelty, with major clinical health impact. In 2 cases concerns regarding significant adverse changes in the risk-benefit profile related to components or source materials of the device(s) were raised. The expert panel often points out deficiencies in the provided clinical evidence including the applied study design and disagrees with the adequacy of proposed PMCF plans. Literature search methodologies and their appraisal by both manufacturer and Notified Body have also been commented on. This presentation will closely analyse two highly interesting examples of provided expert opinions. The experience gained thus far, already offers valuable insight, from which both manufacturers and Notified Bodies might benefit from.

Artificial intelligence (AI)- and machine learning (ML)-based medical devices, once a dream of science fiction writers, have firmly established their place in the market and will continue to gain in popularity in the coming months and years. With uses ranging from virtual assistance to image analytics to robotic-assisted surgeries, manufacturers have only begun to explore the utility and value of these devices.

Such rapid innovation, however, can cause severe regulatory headaches. The relatively controlled and documented methods applied to R&D of conventional medical devices are not traditionally practiced in the highly agile environment of AI/ML algorithm development. This presentation will highlight standards that can be followed to bring an added layer of rigor to the development and documentation of AI/ML-based medical devices. In addition, it will cover Good Machine Learning Practices that will aid manufacturers in designing proper validation and clinical testing procedures to enable a smoother regulatory submission process.

Clinical Evaluation reports are not only needed under the EU regulations but in many other countries as well. Do clinical professionals have sufficient guidance under current regulatory frameworks throughout the world? This presentation will provide an overview of global clinical evaluation guidance and what is in the work at the level of standardization under ISO.