The Medical Devices Introductory Course 2020

EN ISO 14971:2012

ER #s Impacted MDD AIMD IVDD

Include ALL risks

Deviation

1, 2, 6, 7.1 1, 2, 6, 7.1 1, 2, 6, 7.1

A.1, A.2, B.1.1 A.1, A.2, B.1.1 A.1, A.2, B.1.1 A.1 and B.1.1 A.2 and B.1.1 A.2 and B.1.1 A.2 and B.1.1

1 – Treatment of negligible risks

1, 5, 9

Include ALL risks

1, 5, 9

2 – Discretionary power of manufacturer as to acceptability of risks

3 – Risk reduction “as far as possible” vs. “as low as reasonably practicable” 4 – Discretion as to whether a risk-benefit analysis needs to take place No ALARP

1, 5, 6, 9

All risks require B:R

1, 6, 7.1 5 and 9

5 – Discretion as to the risk control options / measures

2 and 7.1

-

Priority Order

Priority Order

6 – Deviation as to the first risk control option

2 and 7.1

-

7 – Information of the users influencing the residual risk

2 and 7.1

-

Warnings on Residual Risk

The Organisation for Professionals in Regulatory Affairs

EN ISO 14971:2012

Manufacturers should demonstrate:

1. Design solutions are in conformity with: inherent safe design and construction > protection measures > information for safety? 2. All risks have been reduced as far as possible 3. A risk benefit analysis has been conducted for all individual residual risks 4. An overall risk benefit analysis has been conducted 5. Effectiveness of information for safety 6. Information on residual risks has been provided to users

The Organisation for Professionals in Regulatory Affairs