---
title: "COMBINE Project 2 – Sponsors' Guide on Safety Reporting in Combined Studies"
description: "The COMBINE Project 2 Sponsors' Guide, published 11 September 2026, helps sponsors align safety reporting across CTR, MDR and IVDR in combined studies."
url: https://qbdgroup.com/zh-cn/regulatory-updates/combine-project-2-safety-reporting-combined-studies
type: "Regulatory update"
language: zh-cn
published: 2026-09-16
author: "Kirsten Van Garsse"
category: "Regulatory Update"
publisher: "QbD Group"
citation: "QbD Group, \"COMBINE Project 2 – Sponsors' Guide on Safety Reporting in Combined Studies\", https://qbdgroup.com/zh-cn/regulatory-updates/combine-project-2-safety-reporting-combined-studies"
---
# COMBINE Project 2 – Sponsors' Guide on Safety Reporting in Combined Studies
> The COMBINE Project 2 Sponsors' Guide, published 11 September 2026, helps sponsors align safety reporting across CTR, MDR and IVDR in combined studies.

On 11 September 2026, the [COMBINE Project 2 Sponsors' Guide on Safety Reporting in Combined Studies](https://health.ec.europa.eu/document/download/911074fa-9288-47a9-9c57-573c2371e918_en?filename=md_combine_p2-sponsor-guide_en_0.pdf) was published following endorsement by the **Clinical Trials Coordination and Advisory Group (CTAG)** and the **Medical Device Coordination Group (MDCG)**. The guide supports sponsors in navigating safety reporting requirements for studies that fall under multiple regulatory frameworks, including the Clinical Trials Regulation (CTR), the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

## What's New?

Combined studies are becoming increasingly common, particularly where medicinal products are investigated together with medical devices, IVDs or companion diagnostics. Sponsors must currently reconcile differing safety reporting definitions, processes, timelines and reporting routes across the applicable frameworks. The new guide provides practical recommendations to support a **consistent and coordinated approach to safety reporting** until a dedicated legislative framework for combined studies becomes available.

### Practical Guidance for Combined Studies

The guide explains how to manage safety reporting obligations when multiple regulatory frameworks apply simultaneously.

### Clarified Differences Between CTR, MDR and IVDR Requirements

It helps sponsors navigate differing definitions, seriousness criteria, causality assessments, reporting obligations and timelines.

### Defined Investigator and Sponsor Responsibilities

Practical guidance is provided for safety event reporting, seriousness and causality assessments, communication pathways and follow-up activities.

### Support for Studies Involving Multiple Sponsors

The guide contains recommended communication flows and reporting arrangements for dual-sponsor and multi-sponsor studies.

### Country-Specific Safety Reporting Information

Detailed annexes provide national reporting routes and requirements for clinical investigations and performance studies across participating countries.

### Known Challenges in Combined Studies

The guide acknowledges issues such as duplicate reporting obligations and identifies areas where further legislative harmonisation may be required.

Combined studies require sponsors to comply simultaneously with multiple regulatory frameworks, each with its own safety reporting requirements. This complexity can create uncertainty and increase the risk of inconsistent reporting. The Sponsors' Guide provides a practical roadmap for managing these challenges: by clarifying expectations and promoting aligned approaches to safety reporting, it aims to support more efficient study conduct while maintaining patient safety and regulatory compliance.

## What Does This Mean to You?

Sponsors planning or conducting combined studies should review the guide carefully and assess whether their current study protocols, safety reporting procedures and communication plans align with the recommendations provided.

The guidance is particularly relevant for studies involving:

- Companion diagnostics (CDx)
- Performance studies under the IVDR combined with investigational medicinal products under the CTR
- Clinical investigations under the MDR combined with investigational medicinal products under the CTR
- Multiple sponsors or multiple regulatory frameworks

## How Can QbD Group Assist You?

QbD Group supports sponsors in interpreting the applicable regulatory requirements, developing compliant safety reporting strategies, preparing integrated study documentation and managing submissions across multiple regulatory frameworks.

Contact our team to review your safety reporting set-up for combined studies in light of the COMBINE Project 2 Sponsors' Guide.
---
Source: https://qbdgroup.com/zh-cn/regulatory-updates/combine-project-2-safety-reporting-combined-studies — © QbD Group. Quote freely with attribution and a link back.