The Virtual (European) Conference on

Clinical Studies with

Medical Devices and IVDs

Dr Melvin will present on clinical investigations and the Medical Device Regulation, in addition to providing an update on recent activity of the Clinical Investigation and Evaluation Working Group and the plans for future work.

Regulation (EU) 2017/745 will be applicable for clinical investigations (CIs) from 26 May 2021. It will do so without full functionality of EUDAMED and the Clinical Investigation/Performance Study (CI/PS) module.
In the absence of a European IT system, national IT systems and processes will have to be used by applicants and Member States to fulfil the requirements of the Regulation.
This presentation will highlight the planned processes for authorisation and oversight for CI at the Austrian Medicines and Medical Devices Agency.
The presentation will cover transitional provisions, authorisation and notification for different types of studies (including Articles 74 (1) and 82), amendments and safety reporting.
There will be a quick look at the Austrian submission form and the necessary changes.
It will also be described how review by the Ethics Committees will be incorporated into the timelines of the Regulation.
After this presentation the audience should have a general overview about the submission and authorisation processes for CIs according to the Regulation in Austria.

Performance Studies grow in their importance and quantity. The IVDR brings immense changes with it and affects IVD-regulation from their classification to the performance evaluation. This presentation is meant to provide clarification on what changes Competent Authorities need to apply in the regulatory framework and how this will affect clinical performance studies from a regulatory perspective. Upcoming application procedures, timelines and applicable legislation and guidance will be addressed. IVDs will experience a bigger change than other medical devices and therefore an elementary introduction to the clinical performance study procedures and potential interfaces to medicinal product studies will be addressed.

One of the major goals of the new European Medical Device Regulation (MDR) is to set high standards of quality and safety for bringing new medical devices to the market or for keeping them available over time. This new Regulation gives a clear and rigorous legal framework within which the Medical Device industry can move itself to achieve its important goal of providing innovative but safe products to patients.

An important portion of the MDR is dedicated to clinical investigations and with good reason: high quality clinical studies are needed to provide reliable and robust clinical data so that manufacturers can use those data to demonstrate that their products are safe, effective and that the patients will achieve meaningful clinical benefits when they receive them. Notified bodies will raise the bar (and already have) when reviewing the clinical evidence provided by a manufacturer during CE marketing approval process, so better to be planning and managing well the studies from day one. Discovering deficiencies during the Technical Documentation review process can be a very unpleasant and costly situation for a manufacturer to manage.

Not all requirements described in the MDR text are new to the medical device world though. Some are, and some were just not included in a legislative text but only within a Standard, a Directive or other Guidance documents. Higher hurdles are in front of us for maintaining or putting new products on the market: let’s make sure we prepare ourselves well to avoid bad surprises when it might be too late.

In my talk I will review and discuss some of the most meaningful MDR requirements for pre-market and post-market clinical investigations, focusing on those which, in my view, have a major impact on the industry and through practical examples and strategies I will give you my perspective on how those aspects might be addressed to ensure our Industry will continue to provide innovative, safe and effective devices to patients worldwide.

ISO 14155:2020 represents the state of the art guidance for medical device clinical investigations for human subjects. The document contains significant updates and is aligned with the latest regulatory requirements worldwide to ensure compliance in showing clinical evidence of a medical device and support patient safety and market access. The requirements of ISO 14155 apply to all clinical investigations pre-and post-market, which is now clarified further and provides extensive information on how to apply risk management throughout all activities of a clinical investigation. By attending this session you will not only learn what is new in ISO 14155, but also how to apply it in your quality system.

The IVD Directive 98/79/EC said very little about the conduct of clinical performance studies and there was no harmonized standard with the same level of detail as ISO14155:2011 on good clinical practice for medical devices.

The new IVD Regulation 2017/746 introduces important new requirements for the conduct of clinical performance studies. It differentiates between studies with no risk for the subject and so called ‘certain’ studies, which pose a risk because of the nature of the sample collection procedure or because of the use of the result in clinical decisions. The latter are called interventional studies. It also pays attention to ethical issues and emphasizes the importance of studies performed in the hands of the intended user.

The new ISO 20916:2019 is aligned with the IVD-R. It defines good study practices for the planning, design, conduct, recording and reporting of clinical performance studies using specimens from human subjects to guarantee that the study will lead to reliable and robust study results, and that the rights, safety, dignity and well-being of the subjects providing specimens are ensured in agreement  with the principles of the Declaration of Helsinki.

The IVD Directive 98/79/EC said very little about the conduct of clinical performance studies and there was no harmonized standard with the same level of detail as ISO14155:2011 on good clinical practice for medical devices.

The new IVD Regulation 2017/746 introduces important new requirements for the conduct of clinical performance studies. It differentiates between studies with no risk for the subject and so called ‘certain’ studies, which pose a risk because of the nature of the sample collection procedure or because of the use of the result in clinical decisions. The latter are called interventional studies. It also pays attention to ethical issues and emphasizes the importance of studies performed in the hands of the intended user.

The new ISO 20916:2019 is aligned with the IVD-R. It defines good study practices for the planning, design, conduct, recording and reporting of clinical performance studies using specimens from human subjects to guarantee that the study will lead to reliable and robust study results, and that the rights, safety, dignity and well-being of the subjects providing specimens are ensured in agreement  with the principles of the Declaration of Helsinki.

As the majority of IVD studies are performed using left-over or archived specimens, there is no risk for the subjects arising from either the result provided by the IVD or from the specimen collection procedure. However, when specimens are specifically taken for the study or the result of the IVD under investigation is used for individual patients, these studies may qualify as ‘certain’ studies and additional requirements will apply. In this context, the standard has been drawn up in such way that the main body includes the minimum requirements for all studies, and the additional requirements for ‘certain’ studies are provided in the normative annexes.

As the majority of IVD studies are performed using left-over or archived specimens, there is no risk for the subjects arising from either the result provided by the IVD or from the specimen collection procedure. However, when specimens are specifically taken for the study or the result of the IVD under investigation is used for individual patients, these studies may qualify as ‘certain’ studies and additional requirements will apply. In this context, the standard has been drawn up in such way that the main body includes the minimum requirements for all studies, and the additional requirements for ‘certain’ studies are provided in the normative annexes.

The MDR includes very specific requirements concerning the evaluation of risks, residual risks, and the resulting benefit/risk ratio alongside those for the conduct of a clinical investigation being conducted for conformity assessment purposes. In addition, EN ISO 14155:2020 includes expanded requirements for risk management during the planning of a clinical investigation, and a new informative Annex indicates the risk management activities that should be carried out before and during the clinical investigation. Although the need to address and evaluate risks in a clinical investigation is not new, the requirements have become more specific under the MDR. This presentation will discuss the key MDR requirements for the interface between clinical investigation and risk management, the expanded risk management activities and new guidance in EN ISO 14155, and advice on how to ensure these activities are aligned and managed in a coordinated manner.

Applying GDPR to a clinical investigation is not new and clinical professionals are well aware of the main principles of GDPR, but are you really applying all aspects correctly? Are you familiar with a data protection impact assessment and what limitations GDPR may impose during remote monitoring? Are all data processors aware of their duties and how data are protected during centralised analysis or transportation outside of the EU? Answers should not be over-simplified or taken for granted. If running clinical investigations is your daily practice, then you will benefit from this practical review of GDPR requirements during EU medical device clinical investigations.