---
title: "Medical device combination products: what regulations should you apply before marketing them in the EU?"
description: "Preparing your Medical Device Combination Products for EU Launch? Learn more on how to apply MDR Article 117 and the EMA Directive."
url: https://qbdgroup.com/en/blog/medical-device-combination-products-regulations-eu
type: "Blog post"
language: en
published: 2021-09-30
author: "Karen De Man & Pieter Gibens"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"Medical device combination products: what regulations should you apply before marketing them in the EU?\", https://qbdgroup.com/en/blog/medical-device-combination-products-regulations-eu"
---
# Medical device combination products: what regulations should you apply before marketing them in the EU?
> Preparing your Medical Device Combination Products for EU Launch? Learn more on how to apply MDR Article 117 and the EMA Directive.

- Questions & Answers for applicants, marketing authorization holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) (europa.eu)
- MDR Article 117: A New Implication for Drug-device Combination Products (celegence.com)
---
Source: https://qbdgroup.com/en/blog/medical-device-combination-products-regulations-eu — © QbD Group. Quote freely with attribution and a link back.