White Paper

Regelmäßig beschäftigt sich das Team von novineon CRO mit den neusten Entwicklungen in Clinical Affairs und verfasst dazu White Paper. Hier finden Sie die wichtigsten Aspekte von MDCG-Dokumenten auf den Punkt gebracht. Außerdem fassen wir in diesen Fachinformationen unsere wichtigsten Erfahrungen aus 250 Projekten jährlich zusammen.

MDCG 2025-9 Guidance on Breakthrough Devices (BtX)

The MDCG 2025-9 Guidance outlines the regulatory framework for breakthrough devices (BtX) under the European Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). Its main goal is to enable timely patient access to innovative devices that address serious, life-threatening, or irreversibly debilitating conditions, without compromising the clinical evidence requirements for these devices. The guidance applies to all technologies and risk classes, except for custom-made devices, in-house devices, and products without a medical purpose.

Status Quo in Clinical Investigations of Medical Devices: Experience with Requirements, Implementation and Opportunities

Dr. Sabrina Rohrer, Head of Clinical Studies at novineon, and Carolin Kurth, Founder and Managing Director of Camovis GmbH, have jointly published a comprehensive technical article in the Medizinprodukte Journal. Across 9 pages, the authors combine well-founded aspects of regulatory legislation with valuable experience from practical implementation.

Milestones on the road to clinical evaluation

According to the MDR, the clinical evaluation should be appropriate to the product, taking into account its characteristics and intended purpose. But what does 'appropriate' mean, and when is the data 'sufficient'? This article describes the six milestones for a successful clinical evaluation.

Types of clinical studies

There are different types of studies for medical devices. The choice depends on the regulatory status, the stage in the product’s lifecycle, and the type of product. In some cases, different approaches may be considered. Below, we describe the relevant types of studies.

Safety and Performance Based Pathway

The Safety and Performance Based Pathway (SPBP) is a special form of the 510(k) that allows comparison to defined parameters instead of a specific equivalent device. This approach already covers several established and well-understood product types at the FDA.

Succeeding in the DiGa landscape

In this article, we will examine how the DiGA landscape has developed in Germany and its direct neighbors in recent years, and whether DiGA have been able to establish themselves within the framework of integrated care. Furthermore, we will focus on exemplary factors that are decisive for sustainable success in the market. Finally, we would also like to provide a brief insight into the further development potential of digital health applications.

Digital health applications (DiGAs) briefly explained

You have wondered what DiGAs are and why they need to be listed in a directory? Below, you will learn the basics about the requirements for listing, what the “positive healthcare effect” has to do with it, as well as future requirements for DiGAs.

How to avoid common problems in the IVDR conformity assessment procedure

Below, we show you ways to ensure the completeness of your submitted files and facilitate the notified body's review.

In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746

Since May 26, 2022, the IVDR has been officially in effect, replacing the IVDD. However, to ensure the transition is as smooth as possible, there are transition periods of varying lengths for products in different risk classes.
Furthermore, some IVDR requirements already apply to products that were certified under the IVDD before or during the transition period.

Clinical evaluation without clinical data

Article 61(10) of the MDR regulates the possibility of conducting a clinical evaluation without clinical data. The cases in which this is possible and the conditions under which this article can be applied are explained below.