To echo, summarize, and add to what has already been said....
The B-R assessment is required by Annex I for both MDD and MDR compliant CERs.
A B-R assessment is also required per ISO14971-2019.
Benefits will be defined by what you claim to be the clinical benefit of your product (based on the intended use)
Risk will be defined by adverse events and patient harms from the risk documentation, any post-market experience, literature, and/or clinical investigations
Be sure that the B-R assessment in your CER ALIGNS with the B-R assessment in your other documentation (i.e., risk, separate BRA, etc.)
------------------------------
Bethany Chung
Principal Regulatory Scientist, RQM+
------------------------------
Original Message:
Sent: 24-Jul-2022 23:05
From: Richard Vincins
Subject: CER - Benefit-Risk Assessment
Hello Christopher,
To add what the others have provided, benefits-risk analysis originates from the Essential Requirements/General Safety and Performance Requirements. While under the EU MDR this is a specific item now in the clinical evaluation Articles and Annex, it has always been a requirement in Annex I. Traditionally the Clinic Benefits-Risk Analysis has been associated with the clinical evaluation (report), but it can and should be part of multiple processes such as risk management, clinical evaluation, and post market surveillance. Where the Benefits-Risk Analysis "lives" is up to each organisation as I have seen it in the clinical evaluation (most common), a stand-alone document as you indicate by a BRA, or even in risk management file. I would also comment the benefit-risk analysis/profile can be contained in different locations or at least referenced in different process (those stated previously).
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 24-Jul-2022 01:22
From: Joy Frestedt
Subject: CER - Benefit-Risk Assessment
Two more cents… I agree- do not exclude.
Link to your indications for use and claims (benefits) and your ISO14971 risk management report (risks).
Also plan for MDR where you will need a proactive PMS (device vigilance), and your CER will need pre-specified and pre-quantified safety and performance measures and thresholds.
Remember software as a device (or in a device) has special rules. Be careful with cyber security, etc. Patient monitoring can be a risky business even when WET (well established technology) - can't think of an example when PMS would not be required… note your risk here.
Also, no time like the present to start itemizing and quantifying the benefits and risks as a good clinical practice.
Conversely, be sure CER Clinical data are "deemed appropriate" to collect under article 61 clause 10. The info provided is really not sufficient to fully answer the question posed. Be sure to state why the device is not novel too.
------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
Original Message:
Sent: 23-Jul-2022 10:54
From: Anne LeBlanc
Subject: CER - Benefit-Risk Assessment
Two cents - no, don't exclude it. Say it very simply as you've just done here. Obvious benefits, no known risks. Summarize it for your readers so they don't have to work hard to understand the document.
------------------------------
Anne LeBlanc
United States
Original Message:
Sent: 23-Jul-2022 02:41
From: Christopher Chin
Subject: CER - Benefit-Risk Assessment
Can Benefit-Risk Assessment (BRA) be excluded in a clinical evaluation report under MDD when there are no PMS data or FSCAs? The subject is a patient monitoring device which is a standard of care with long history on the market, simple to use, has well-known clinical performance and has not been associated with safety issues.
Your two cents input is much appreciated.
Christopher Chin