Combination Products Operational Group

The Combination Products Operational Group (COMBO) fosters dialogue and addresses regulatory challenges for combination products. These are medicinal products used in combination with a medical device.

The group aims to facilitate dialogue on regulatory challenges at the intersection of pharmaceutical and medical device frameworks.

Combination products are medicines used in combination with a medical device or products that have to apply certain requirements from both medicine and device regimen.

The work of the group focuses on:

• medicines that form an integral product with a medical device
• medicines that include a co-packaged medical device;
• medicines in exclusive use with a medical device, including in vitro diagnostics, referenced in the product information and supplied separately;
• companion diagnostics;
• medical devices incorporating an ancillary medicinal substance;
• medical devices composed of (a combination of) substances that are systematically absorbed. 

For more information on EMA's work with medical devices, see:

• Medical devices

Also on this topic

• Combination Products Operational Group meetings and agendas

Role

The group aims to facilitate dialogue on regulatory challenges at the intersection of pharmaceutical and medical device frameworks.

It engages stakeholders across medicine, medical device, and in vitro diagnostic sectors to promote a shared understanding of respective regulatory frameworks, roles, and assessment processes.

This aims to foster alignment and coordination in the assessment of products at the interface of medicines and medical devices.

It also explores potential solutions to technical and procedural challenges for combination products in a collaborative way, with the aim to develop and update guidance.

Terms of reference

Combination Products Operational Group (COMBO) - Terms of reference

Reference Number: EMA/219064/2025

Composition

The group consists of experts from competent authorities, respectively responsible for medicines and medical devices, notified bodies, EMA, and the European Commission.

It is structured into two dedicated streams:

• The medical devices stream
• The in-vitro diagnostics (IVD) stream

Members bring expertise in combination products, consultation procedures, medical devices and in vitro diagnostics, particularly companion diagnostics.

The group may also involve alternates and ad hoc experts as needed to support topic-specific discussions.

Members

Medical Device (MD) stream

Medicines Competent Authorities

• Joacim Elmén 
• Barbora Ladinová 
• Johan Sällström 
• Elisabeth Strutzmann 

Devices Competent Authorities

• Sónia Cardoso
• Rainer Edelhaeuser 
• Patrick Murphy 
• Almuth Wiesner 

Notified Body Coordination Group (NBCG-Med)

• Sebastian Fisher 
• Ana Fonte 
• Theresa Jeary 
• Virginie Siloret 

In vitro diagnostic (IVD) stream

Medicines Competent Authorities

• Jörg Engelbergs
• Ilona Reischl
• Patrick Vrijlandt

Devices Competent Authorities

• Gaëlle Le Brun
• Irene Sánchez de Puerta de Miguel
• Ryszard Wojciechowicz

Notified Body Coordination Group (NBCG-Med)

• Elizabeth Harrison
• James Hewitt
• Rolf Thermann