Notification of devitalised human tissue

A distinction is made between two groups of products containing devitalised human tissue.

a) MD-DEVIT products, which are considered to be medical devices according to MedDO (Medical Devices Ordinance of 1^st July 2020, SR 812.213) / MDR (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices)

b) DEVIT products that continue to be subject to regulation according to oMedDO (Medical Devices Ordinance of 17 October 2001, SR 812.213 (Status as of 1 August 2020)).

Device Registration (MD-DEVIT products)

The registration of MD-DEVIT products according to Art. 108 MedDO will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026. Device registration

The registration obligation replaces the notification obligation by 1st July 2026.

MD-DEVIT products must undergo a conformity assessment procedure for medical devices and require CE marking:

1. According to Art. 1, para. 3 letter c number 2 MedDO: products manufactured from derivatives of tissue or cells of human origin that are not viable or that have been killed off.
2. According to Art. 1 para. 3 letter d MedDO: products which contain non-viable tissue or non-viable cells of human origin, or the derivatives of such tissue or cells, as an integral constituent part at the time the products are placed on the market or put into service and where such tissue, cells or derivatives assume a supporting function in such products.

Notification of devitalised human tissue (DEVIT products)

The notification obligation according to art. 103 para. 2 MedDO remains in place for DEVIT products covered by Art. 2a para. 2 TPA until such time as a corresponding special Ordinance is issued.

These include:

1. All products made from devitalised human tissue or cells, with the exception of derivatives of such tissue or cells
2. Products which contain non-viable tissue or non-viable cells of human origin, or the derivatives of such tissue or cells, as an integral constituent part at the time the products are placed on the market or put into service and where such tissue, cells or derivatives assume a primary function in such products.

There is a general obligation to notify Swissmedic if the product is placed on the market in Liechtenstein and/or Switzerland.

The following Information sheet provides further details on this subject:

Please use the following form for notifying these products:

Please use the following form to report changes to devices that are already notified with Swissmedic:

Organs, tissues or cells of human or animal origin and products obtained from them (transplant products) which contain living cells and are intended for transplantation to humans are subject to the Transplantation Act (SR 810.21 Federal Act on the Transplantation of Organs, Tissues and Cells). These products are subject to notification and authorisation requirements, which can be found via the following links:

For transplant products:

For organs, tissues or cells of human or animal origin: