Medical devices made of substances that are systemically absorbed

Information on the European Medicines Agency's (EMA) role in the regulatory process for medical devices made of substances that are systemically absorbed.

Some medical devices are made of substances that are absorbed by the human body to achieve their intended purpose.

These devices are normally introduced into the human body via an orifice or applied to the skin.

For information on other types of medicine-device combination products, see:

• Medical devices with an ancillary medicinal substance
• Medicinal products used in combination with a medical device

EMA role

Before it can issue a CE certificate, the notified body must seek a scientific opinion from EMA or a national competent authority on the compliance of the substance with the requirements laid down in Annex I to Directive 2001/83/EC.

EMA will provide further information on the consultation procedure between the notified body and a competent authority or EMA. 

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.

See update history

2 March 2026

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