Medicinal products used in combination with a medical device

Guidance on the marketing authorisation dossier requirements for a medicine when it is used with a medical device and information on conformity assessment requirements for the device component

Some medicines are used in combination with a medical device, usually to enable the delivery of the medicine.

If the medicine achieves the main intended action, it is considered a medicinal product that includes a medical device.

The entire medicinal product is regulated under EU pharmaceutical legislation, Directive 2001/83/EC or Regulation (EC) No 726/2004. 

The product must obtain a marketing authorisation for a medicinal product.

For more information on medical devices, see:

• Medical devices

EMA role

The European Medicines Agency (EMA) is responsible for evaluating the quality, safety and efficacy of marketing authorisation applications assessed through the centralised procedure. This includes the safety and performance of a medical device in relation to its use with a medicinal product.

The medical device may be co-packaged with, obtained separately from or integral to the medicinal product.

Requirements for conformity assessment

The device part of the combination may require a conformity assessment, as described below.

• Integral:

  Presentation: Medicine and device form a single integrated product

  Examples include:

  • reusable pen for insulin cartridges
  • tablet delivery system with controller for pain management

  Applicable requirements:

  • Marketing authorisation application should include a CE certificate for the device or, if not CE marked but would need to be certified if marketed separately, applicant must include an opinion from a notified body on conformity of device
  • Requirement does not apply to Class I devices (non-sterile, non-measuring)
  • Requirement applies since 26 May 2021 under article 117 of Medical Devices Regulation
• Co-packaged or obtained separately:

  Presentation: Medicine and device are separate items contained in same pack or obtained separately

  Examples include:

  • pre-filled syringes and pens
  • patches for transdermal drug delivery
  • pre-filled inhalers

  Applicable requirements:

  • Must be CE marked in accordance with EU medical devices legislation

Guideline on quality documentation for medicines that include a device

EMA issued a final guideline on quality documentation for medicinal products that include a medical device in July 2021. 

This guideline clarifies expectations laid down in Directive 2001/83/EC. 

It also addresses obligations in the Medical Devices Regulation, in particular under Article 117.

EMA recommends reading the guideline in conjunction with the Q&A on the implementation of the Medical Device Regulation and In Vitro Diagnostic Devices Regulation.

Guideline on quality documentation for medicinal products when used with a medical device - First version

Adopted Reference Number: EMA/CHMP/QWP/BWP/259165/2019 Legal effective date: 01/01/2022

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2 March 2026

Page first published; Content has been moved from another webpage as part of a broader content reorganisation