Essentials of European Medical Device Regulatory Affairs

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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Classification Exercise

Product

Non Invasive (1,2,3,4) Invasive (5,6,7,8) Special rules (13‐18)

Duration <60 mins transient <30 days short term >30 days long term

Rule

Classification

A Hydrocolloid (creates a moist  environment) plasters B Corrective daily contact  lenses C Corrective contact lenses  continuous wear for a year

Non‐invasive

Short term

Invasive (in a body orifice) Invasive (in a body orifice)

Short term

Long term

D Device for self 

Surgically invasive Transient

administration of a medicine  (not infusion, but short)

E Dentist hand held mirror

Invasive

Transient

F Contact lens solution

Special rule

G Breast implants

Surgically invasive Long term

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