Certification mark for Cybersecurity for medical devices and IVD devices

Certification mark for Cybersecurity for medical devices and IVD Devices

SCOPE:

If customers undergo a conformity assessment under IVDR/MDR they receive a certificate related to the intended purpose of the device(s). They do not get certificates for the conformity of software related topics or any other kind of testing. Medical device and IVD manufacturers have the need to demonstrate that their delivered products fulfil a certain level of quality which can be proven by the TÜV SÜD marks, here for cyber security.

BASIS OF CERTIFICATION (REQUIREMENTS):

Test methods:

• The software was tested according to PPP 48003, a test program developed by TÜV SÜD

KEY STATEMENTS OF CERTIFICATION MARK:

• The device is in conformity with TÜV SÜD's cybersecurity criteria for medical devices / IVD devices