Essentials of European Medical Device Regulatory Affairs - October 2019

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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IVDR classification

Is a Notified  Body  Required?

Class D

Blood screening for life threatening entities e.g. suitability  for transfusion

Yes

Class C

Detection of infectious agents Selection of patients e.g. companion diagnostics Genetic testing Diagnosis of cancer

Yes

Self testing (critical outcome) Blood glucose determination Self testing ( noncritical outcome) Anything not in A, C and D Reagents Instruments for IVD procedures Specimen receptacles

Class B

Yes

Class A

NO:

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