White Paper

The novineon CRO team regularly examines the latest developments in Clinical Affairs and publishes white papers on these topics. Here, we present the key aspects of MDCG documents in a concise and accessible format. In addition, these expert publications summarize our most important insights and experiences from 250 projects each year.

EU Reference Laboratories for Class D IVDs

Understanding the role and requirements associated with EURLs is essential for a successful conformity assessment and market access.

Case Study – US Clearance: Product Overhaul After More Than 10 Years on the Market

What matters is the delta between the last cleared product configuration and the current product design, as well as the ongoing evolution of the regulatory landscape.

US Clearance: Innovation Within the Constraints of "Substantial Equivalence" – A Case Study

With more than 3,000 submissions per year, the 510(k) is the most common regulatory pathway for medical devices in the United States.

Clinical Decision Support Software (CDS) – Medical Device or Not, and How the FDA Draws the Line

Many products, particularly in the software sector, target workflows in hospitals and clinical decision-making. This quickly raises the question: Is this a medical device or not?

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.

Understanding FDA Product Classification for Medical Devices

While product classification in Europe follows the regulatory framework set out in Annex VIII of the MDR, no direct equivalent can be found in FDA documentation. novineon CRO supports medical device manufacturers on their path to the US market. In this article, Amko Groeneveld describes what to consider when classifying a product.

Periodic Safety Update Report

Lessons from the MDCG 2022-21 Document
Long awaited and widely anticipated, the guidance paper MDCG 2022-21 "Guidance on Periodic Safety Update Report According to Regulation (EU) 2017/745 (MDR)" was published shortly before the turn of the year 2022/2023. Dr. rer. nat. Timo Weiland summarizes the key takeaways from the document.

Clinical Evaluation Consultation Procedure: To-Dos for the Clinical Evaluation

Transparency and the protection of public health and patient safety have become particularly important under the MDR. In order to keep pace with scientific and technical developments and to overcome diverging interpretations, the EU has established Expert Panels. These may be consulted by Notified Bodies in the context of the conformity assessment of certain medical devices. What is an Expert Panel? When must a product undergo the consultation procedure? What role does the clinical evaluation play? These questions are addressed in this article.

Borderline Products

Different regulatory requirements apply in the European market depending on the product category. Difficulties arise with product categories that cannot be clearly assigned to a single regulatory framework, or that fulfill multiple regulatory definitions. Such products are referred to as borderline products. In this article, we describe the definitions of medicinal products, medical devices, combination products, and wellness products.

Post-Market Surveillance: Post-Market Surveillance Reports

With the first anniversary of the MDR approaching, so too is the end of the first evaluation period for post-market surveillance. Having collected data through the post-market surveillance system, the time has now come to analyze and summarize those findings. Dr. rer. nat. Benedikt Fabry of novineon CRO describes in the following article the differences between the various reports and where the primary focus should lie when preparing them.

Risk Management and Warnings: How Risks Can Be Reduced

That the risk analysis is a living document should be well understood by now, at the latest since the introduction of the EU Medical Device Regulation 2017/745 (MDR). The risk analysis evaluates risks that were either anticipated prior to market launch or have come to light during real-world clinical use. It is often tempting to address a risk through the instructions for use and thereby reduce the probability of its occurrence. This article explains when this measure is sufficient, and how the risk analysis relates to the clinical evaluation.

Well-Established Technologies: What Does MDCG 2020-6 Require?

Many medical devices have been on the market for years or even decades. But does that automatically qualify them as "well-established technologies"? And what does this mean in concrete terms for the clinical evidence required by the MDR? Dr. rer. nat. Marion Fehlker of novineon CRO describes below what the MDR and the MDCG documents understand by well-established technologies, and what clinical requirements apply to products in this category.

The Instructions for Use – More Than Just a Requirement

The instructions for use represent the direct interface between the manufacturer and the user. This document therefore carries particular significance. The requirements for the instructions for use have become even more stringent and precise under the MDR. The following article outlines when the instructions for use should be revised, and discusses the key interfaces between the instructions for use, the clinical evaluation, and the risk analysis.

Guide to MDCG Document 2020-6

With the document MDCG 2020-6, the Medical Device Coordination Group addresses the widely debated topic of "sufficient clinical data" for so-called legacy devices, and provides guidance on how to navigate the resulting regulatory requirements.