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Health Medical Device? Is your software a
Medical Device Software (MDSW): Software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR). B Yes A Decision steps to assist qualification of Medical Device Software (MDSW) Is the product a ‘Software’ according to the definition of MDCG 2019-11? 2.1. NoYes Yes Yes Yes Is the software an ‘MDR Annex XVI device’, an ‘Accessory’ for a medical device according to Art. 2(2) of the MDR or IVDR or ‘software driving or influencing the use of a (hardware) medical device’? Is the software performing an action on data different from storage, archival, communication or simple search? Is the action for the benefit of invidual patients? Is the software a Medical Device Software (MDSW) according to the definition of MDCG 2019-11?
- 3. 4. 5.
COVERED BY
THE MEDICAL DEVICES
REGULATIONS*
COVERED BY
REGULATION (EU) 2017/746 (IVDR)
NOT COVERED BY
THE MEDICAL DEVICES
REGULATIONS*
Yes Yes
NOT COVERED
BY MDCG 2019-11
No No No Is your MDSW an In Vitro Diagnostic Medical Device Software (IVD MDSW) or a Medical Device Software (MD MDSW) Is your software a Medical Device Software? Medical devices Regulations* refers to the two applicable regulations: Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) MDSW according to the definition of MDCG 2019-11
- 1. 2. 3. Does the MDSW provide information within the scope of the IVD definition? Does the MDSW provide information based on data obtained by IVD medical devices only? Is the intended purpose substantially driven by IVD data sources?
COVERED BY
REGULATION (EU) 2017/745 (MDR)
NoYes No No No