PMS (Premarket Submission) and PMCF Plan

[Scheppa1981]

I am currently creating our PMS plans which include our assessment regarding the need to PMCF. One of the questions I am getting stuck on regarding PMCF determination is "Device used in high-risk patient populations such as elderly or pediatric patients" AND "Device used in high-risk anatomical locations" Reference: MEDDEV 2.12/2 REV 2.

My question is - what is considered a high risk anatomical location? (We primarily have Class I and Class IIa devices in my company, but some of these devices are inserted into the urethera or into stomas, is this considered high risk anatomical location?

My 2nd question - pretty much all of my company's devices can be used in the adult, geriatric, and pediatric and infant population but these devices again are Class I and Class IIa devices. Would these patient populations be considered high risk for these device classes?

Looking forward to any responses or insights.

Thanks

 

[joherjerwalla]

Hi
The classification should be different in the new MDR perspective and may have moved up/ critical.
Work for a PMCF protocol considering ' high risk '.
I shall check back with my Team of assessors ( I work for a MDR NB now) and try to revert back.
Best Regards.

 

[yodon]

Does the risk increase if used on pediatric or geriatric patients?

I think the overall idea is to ensure you have sufficient clinical data to support your claims to safety and effectiveness. Do you have clinical data showing, for example, that use on all populations is safe? Any trends with different populations?

These questions are (at least I believe) intended to drive the thought process on considerations regarding safety and effectiveness and not so much absolutes; i.e., "if yes then..."

 

[Watchcat]

I would consider an anatomical location high risk if it is 'life-sustaining," e.g., heart, brain, other organ that, it stops working, pretty soon you die. Other anatomical locations, the risk is secondary, for example, infection due to sterilization failure might also kill you, and be more likely to do so if the location is internal instead of external, but that risk is not from the location, but from the infection.

Just my thoughts. I concur with yodon aboutthe need to think it through rather looking for something clear cut, like a decision tree.

 

[Giovanna Miranda Araújo]

Olá pessoal,

meu nome é Giovanna Miranda, gerente de qualidade em uma empresa de produtos de saúde no Brasil. Estamos nos adaptando à transição para o novo MDR, infelizmente aqui no Brasil há escassez de treinamento e estamos muito confusos com a utilização. Você poderia me ajudar com exemplos de palavras? Somente a estrutura que cada documento deve ter. Precisamos:
Plano e relatório do PMS ; Plano e relatório do PMCF ; Plano e relatório do PMV
Exemplo de declaração de interesse individual da equipe clínica responsável pela avaliação clínica.
Meu e-mail: [email protected]
Agradecemos antecipadamente a sua atenção e ajuda, será muito bem-vindo.
obrigado

 

[Watchcat]

https://www.linkedin.com/in/marceloantunes/

 

[Mrs Dean]

Hi everyone,

I have one question regarding the PMS plan. What are the metric/ threshold value need to be put for the Data Collection activities?
Activity: Incident documentation and analysis of undesirable side effects
Metric / Threshold: ??

Thanks in advance!

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