Essentials of European Medical Device Regulatory Affairs

MDR- Software rule 11

If such decisions have an impact  that may directly or indirectly  cause: – the death or an irreversible  deterioration of the state of health ‐ a serious deterioration of the state  of health or a surgical intervention

Software intended to  provide information  which is used to take  decisions with diagnosis  or therapeutic purposes

Class III

Class  IIa

Except

Class  IIb

Software intended to  monitor physiological  processes.

‐ If it is intended for monitoring of  vital physiological parameters, where  the nature of variations is such that  is could result in immediate danger  to the patient.

Class  IIa

Except

Class  IIb

All other software

Class I

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IVD classification

Is a Notified Body Required? Yes:  design dossier review (includes compliance to common technical  standards) Audit of Quality Management System  Batch released by the NB Yes: Audit of technical documentation & quality management system

Annex II List A

HIV Hepatitis ABO blood grouping

Annex II List B

Rubella  PSA*  self test for blood glucose

Self Test

Pregnancy self test

Yes: review of design & labelling for lay user  suitability

General

Test for hormones cardiac markers hematology and clinical chemistry tests

NO: Manufacturer self declares

* only cancer test listed

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