Medical devices with an ancillary medicinal substance

Notified bodies in the European Union must seek a scientific opinion from the European Medicines Agency (EMA) on the quality and safety of certain ancillary substances incorporated in a medical device.
HumanMedical devicesRegulatory and procedural guidance

A medical device may contain an ancillary medicinal substance to support the proper functioning of the device.

Examples of medical devices with an ancillary medicinal substance include:

  • drug-eluting stents;
  • bone cement containing an antibiotic;
  • catheters coated with heparin or an antibiotic agent;
  • condoms coated with spermicides.

These products fall under the Medical Device Regulation (EU) 2017/745 and must be CE marked.

For more information on medical devices, see:

In this section

Consultation procedure

Guidance for notified bodies on the EMA consultation procedure on an ancillary medicinal substance incorporated in a medical device

Opinions

Assessment reports on opinions by EMA’s CHMP on ancillary medicinal substances incorporated in medical devices

Assessment templates and guidance

The assessment report template and guidance documents used for the assessment of an ancillary medicinal substance incorporated in a medical device

EMA scientific opinion

Before it can issue a CE certificate, the notified body must seek a scientific opinion from EMA on the quality and safety of the ancillary substance, if the substance:

  • is derived from human blood or plasma
  • has been previously evaluated by EMA
  • falls under the mandatory scope of centralised procedure

For other substances, the notified body can seek the opinion from a national competent authority or from EMA. For instance, in cases where EMA has already evaluated a medicine containing the same medicinal substance.

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in March 2026.

2 March 2026

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

Share this page