Notification of devitalised human tissue
A distinction is made between two groups of notifiable products containing devitalised human tissue.
a) MD-DEVIT products, which are now considered to be medical devices according to MedDO (Medical Devices Ordinance of 1st 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)).
The following Information sheet provides further details on this subject:
MD-DEVIT products
As of 26 May 2021, the following products must undergo a conformity assessment procedure for medical devices and require CE marking:
- 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.
- 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.
These products are subject to notification according to Art. 108 para. 1 letter b MedDO in conjunction with Art. 6 para. 3 oMedDO until Art. 17 para. 5 MedDO comes into force.
Please use the following form for notifying these products:
Please use the following form for notifying variations for MD-DEVIT products:
DEVIT products
DEVIT products according to Art. 2a para. 2 TPA (Therapeutic Products Act of 15 December 2000, SR 812.21 (Status as of May 26, 2021)), have to be notified until a special ordinance is issued in accordance with Art. 103 para. 2 MedDO in combination with Art. 6 para. 3 oMedDO. These include:
- All products made from devitalised human tissue or cells, with the exception of derivatives of such tissue or cells
- 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.
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:
