Combination Products Operational Group

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.

Mandate

EMA will provide the mandate of this operational group as soon as available.

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