Guidelines for the manufacturing of medical devices

The coronavirus pandemic and the possible shortage of medical devices pose a major challenge to the usual production and distribution channels of medical devices. The Federal Agency for Medicines and Health Products (FAMHP) provides adapted guidelines for manufacturers who wish to help in providing more options for care institutions. 

The manufacture of medical devices through channels other than the usual ones can provide a solution to the shortages caused by the Covid-19 pandemic. The aim is to address these shortages of essential materials. This can be done through the in-house production of a selection of medical devices or by reprocessing medical devices, normally for single use. Many technologies, including 3D printing, can be used for this purpose. Manufacturers who operate in this field and want to help must, of course, adhere to certain guidelines when venturing into medical devices.

A recent circular letter from the FAMHP sets out the framework of how healthcare institutions can have more opportunities to work with external partners on alternative solutions. The circular sets out the conditions and stipulations under which this can be allowed to respond to the emergency situation.

All guidelines for medical devices during the COVID-19 pandemic can be found on the Guidance COVID-19 page, on the FAMHP website.