In the broad sense, you will need to implement the new version of 14971 scheduled for publication in 2018-Q4 or 2018-Q1. For the European version, there will be five Z annexes (MDD, IVDDD, AIMD, MDR, and IVDR). They restore the traditional approach of tables and do not use the content deviation approach in EN ISO 14971:2012.
You mention the use of FMEA. If you use FMEAs to identify hazards and analyze hazards, then you are out of compliance with the MDR and the various versions of 14971. The requirement is to identify hazards in both normal and fault conditions. An FMEA does not identify a hazard in normal conditions; it is the wrong tool for the hazard analysis.
You must conduct a benefit-risk determination and use the risk management system to identify both the benefit and the risk. You must also determine the risk-benefit ratio, establish indicators and thresholds, and use the production & post-market surveillance information to update it.
In addition, the MDR has many situations that require an understanding of side-effects. A search of the MDR uncovers phrases such as known side-effects, undesirable side-effects, etc. I think the easiest method to handle side effects is to recognize them as instances of residual risk and document them for each combination of hazard, sequence of events, hazardous situation, and harm. Then disclose them as residual risks (which is required by the MDR).
Documenting side-effects this way helps subsequent analysis of post-market information, benefit-risk, and determination of the need for any PMCF studies.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 26-Oct-2018 14:14
From: Vadivelan Dharanisingh
Subject: Identifying new product related Risk items in EU MDR
Hi,
We are now updating the product RIsk documents such as RMR, DFMEA,AFMEA and other risk documents with the new MDR higlighted risks for the medical device.(our product is a syringe with needle -class IIa)
So i would like to know if i am missing any other risks related to the product (mentioed below)which need to be add to my risk documents.
1. RMP for each device.
2.Identification of risk controls and explicit traceability to their implementation and verification, including identification and mitigation of usability risks within the use environment.
3. CMR and Endocrine risks
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Vadivelan Dharanisingh
Product Regulatoy Lead
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