Combination Products: EMA to release Draft Guidelines concerning Article 117 MDR requirements

Products that contain both medicinal products and medical devices pose regulatory challenges, and the EMA plans to consult on the marketing authorisation requirements for these products over the coming months.

The European Medicines Agency (EMA) has announced that it will publish a draft guideline on the regulatory requirements for combination products (‘drug-device products’), with particular emphasis upon the requirements in Article 117 Medical Devices Regulation (MDR) (Regulation (EU) 2017/745). This aims to complement the Q&A released in February 2019.

Combination products are medicinal products with a device element, that come in the form of either an integrated product (‘integral’ drug-device) or two separate but co-packaged products (‘co-packaged’ drug-device’).

Article 117 MDR will impose marketing authorisation requirements for products fulfilling all the below criteria:

  1. Integral products
  2. Intended for use only in the drug-device combination
  3. That are not reusable

Under Article 117, the marketing authorisation application for ‘integral’ products must contain one of the below:

  • CE certificate for the device; or
  • Declaration of CE conformity for the device; or
  • Opinion from a Notified Body on the CE conformity of the device

The draft guidance will be released in June 2019, and is expected to be open for consultation for 3 months. The EMA will aim to release the final guidelines by 26th May 2020, when the MDR becomes fully applicable.

The latest information from the EMA can be found here.

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Published on 23. May 2019 in News, News EU