Do you think we can use this change in the future MDR to argue that AFAP was never intended in current MDR and the above consensus has been effectively accepted as evidenced by the new MDR?
The main problem right now is that:
1 - The interpretation of the future MDR is right now is only this- an interpretation
2 - You are not complying with the MDR, but with the old directives, so any acceptance will depend on your NB accepting the future requirements
Also,
If the new MDR 'fixes' the ASAP, then why does EN13485:2016 appear to endorse ISO14971:2012’s Annex ZA seven deviations in compliance with 93/42/EEC MDD, as if unaware that the new MDD 2017 has removed the reason for these deviations?
Or can we expect a new EN13485:2020 when the new MDR takes effect?
EN13485:2016 was created before the MDR was published, all/many standards will need to be revised.
Quote:
In Reply to Parent Post by michael Cejnar View Post
is there any way we mere mortals can know this - whether the Consensus has "Interim NBMed status" as per Northbridge or it's 'rejected' by someone?
I don't remember Marcelo's exact explanation, I just vaguely remember that he commented on that. I have no special search powers and you're just as qualified as me to track down that post. Perhaps Marcelo would be able comment on it again, here (my thanks in advance).
The document was created by NB-MED (which is an"association of NBs, not an official EU document) to try and solve the problem with EN 14971, however, it has never been endorsed by the EU Commission, in part because the deviations from 14971 came from the EU Commission. Unfortunately, I don't know any "formal" way to show it's no endorsed besides there being no endorsement.
"The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio."
The regulation expects me to do this for all risks.
If I have a look at the benefit-risk ratio (B/R) during risk mitigation, there are 3 ways how it may behave:
1. The ratio stays the same: B1/R1=B2/R2
2. The ratio increases: B1/R1<B2/R2
3. The ratio decreases: B1/R1>B2/R2 ("adversely affecting the benefit-risk ratio")
Obviously there's still no consensus on this, but I would take care with your comments. The benefit/risk ratio only makes sense in evaluating the device (aggregate) risk, not every individual risk.
One example of in interpretation (which would be in line with at least the MEDDED on Clinical Evaluation:
If your device (aggregate) benefit/risk profile is evaluated by using the following principles (from the FDA
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions. and also cited in the Clinical evaluation
MEDDEV):
Benefit Assessments evaluated by evaluating:
Type of benefit(s)
Magnitude of benefit(s)
Likelihood of patients experiencing one or more benefits
Duration of effects
Patient perspective on benefit
Benefit factors for healthcare professionals or caregivers
Medical necessity
Risk Assessments evaluated by evaluating:
Medical device-related deaths and serious injuries
Medical device-related non- serious adverse events
Medical device-related events without reported harm
Likelihood of Risk
Distribution of Nonconforming Devices
Duration of the exposure to the population
What are the consequences of a false positive?
What are the consequences of a false negative?
Risk from false-positive or false- negative results for diagnostics
Patient tolerance of risk
Risk Factors for healthcare professionals or caregivers
Other factors as in the potential decisions based on the Benefit-Risk Assessment Outcome worksheet
Then, this evaluation would be the aggregate benefit/risk profile evaluation. Note that this do not focus individual risks. So, the statement:
"The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio."
Would mean that, without adversely affecting the the results of this aggregate benefit/risk evaluation.