The Medical Devices Introductory Course 2020

ISO13485:2016

Clause 4.1.2: the organisation shall apply a risk based approach

Clause 4.1.5: …the organization…outsource process that affects product conformity…controls proportionate to the risk

Clause 7.1: the organization shall document one or more processes for risk management in product realization

Clause 7.1 Note 1: NOTE Further information can be found in ISO14971

Clause 7.3.3: inputs relating to product requirements …. these inputs shall include…. applicable output(s) of risk management

Clause 7.3.9: review of D&D changes… evaluation of the effect of the changes on… inputs or outputs of risk management…

Clause 7.4.3: …extent of verification activities… based on the supplier evaluation results and proportionate to the risk…

Clause 7.5.6 / 7.6: …specific approach & activities with software validation and revalidation…proportionate to the risk

Clause 8.2.1: …information gathered in feedback process … input into risk management for monitoring & maintaining product

The Organisation for Professionals in Regulatory Affairs

Risk Management & MDR – benefit:risk

a) Evaluation of the description of the intended purpose of the device

b) Evaluation of the device’s benefits to the patient

c) Quantification of benefit(s) to the patients

• Probability of the patient experiencing one or more benefit(s)

• Duration of effect(s)

d) Evaluation of the clinical risks of devices (extent of risk(s) / harm(s), the following should be addressed individually and in aggregate):

• Severity, number and rates of harmful events

• Probability of a harmful event

• Duration of harmful events

• Risk from false-positive or false-negative results (diagnostic medical devices)

e) Evaluation of acceptability of the benefit/risk profile

The Organisation for Professionals in Regulatory Affairs