Essentials of European Medical Device Regulatory Affairs - June 2020

Standalone Software - current

• Rules 9, 10,11 and 12 on active devices need to be reviewed • Current no specific rule for software in MDD

TheOrganisation for Professionals in Regulatory Affairs

MDR- Software rule 11

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

If suchdecisionshavean impact thatmaydirectlyor indirectly cause: –thedeathoran irreversible deteriorationof the stateofhealth - a seriousdeteriorationof the stateofhealthor a surgical intervention -If it is intended formonitoringof vitalphysiologicalparameters, where thenatureof variations is such that is could result in immediatedanger to thepatient.

Class III

Class IIa

Except

Class IIb

Software intended to monitorphysiological processes.

Class IIa

Except

Class IIb

All other software

Class I

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Classification Exercise

Product

Non Invasive (1,2,3,4) Invasive (5,6,7,8) Specialrules (13- 18)

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

Rule

Classification

A Hydrocolloid (creates a moist environment) plasters B Corrective daily contact lenses

Non-invasive Short term

Invasive (in a body orifice) Invasive (in a body orifice) Surgically invasive

Short term

C Corrective contact

Long term

lenses continuous wear for a year

D Device for self

Transient

administration of a medicine (not infusion, but short)

E Dentist hand held mirror

Invasive

Transient

TheOrganisation for Professionals in Regulatory Affairs

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