PMCF or Post-Marketing Clinical Follow-Up with Helene Quie (MDR 2017/745)

► Webpage: podcast.easymedicaldevice.com/57
PMCF or Post-Marketing Clinical Follow-Up is a cornerstone of the Medical Device Regulation 2017/745.
This is why I took the opportunity to ask some questions about it to Helene Quie from Qmed Consulting. I met Helene at Medica 2019 in Dusseldorf and she accepted to help the audience to have a better understanding of PMCF.
Helene was part of the podcast episode 40 where we discussed Clinical Evaluation Reports or CER and specifically about the way to prove the equivalence between devices.
PMCF is part of this big box that is PMS or Post-Market Surveillance and this can be a good strategy to start one so you can collect data from the market and use them to prove that your products continue to be safe. This is more important for products that are transitioning between MDD and MDR and which do not have data available.
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► Who is Helene Quie
CEO at Qmed-consulting - experts in creating value-based documentation for innovative medical devices getting access to the markets through strong and honest partnerships with our clients.
It is my vision to enable better health through close collaborations with large established or newly started medical device manufacturers, small venture based innovative companies, venture funds, notified bodies, hospital, doctors and nurses within a wide range of medical device products and concepts from high-risk complex products such as heart valves with biological tissue to lower risk class products such as dental care products.
I believe that we through our trusted partners and colleagues can change the treatment of sick patients - making sure frontier products reach the patients and end-users, saving patient’s lives.
Together with the Qmed team, I have provided advice and/or operational services for several clients since 2006 within clinical and regulatory affairs, quality management, reimbursement, and health economics and market access with presence through our Qmed team and trusted partners in Europe, US, Canada, India, and Australia.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses...
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► Links from the Video
■ Helene Quie Linkedin: / helene-quie-863a323
■ Qmed Consulting: www.qmed-consulting.com/
■ MEDICA Video: • Why MEDICA COMPAMED 20...
■ Episode 40 - CER product equivalence: podcast.easymedicaldevice.com/40
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#medtech #medicaldevice #compliance

[@katemvisio1043]

Thank very much Monir. You are doing a great job.

[@talitafeitosa4836]

Excellent participation. Very useful information. Thanks a million.

[@EasyMedicalDevice]

Awesome. Happy that you liked it

[@drrutledge1000]

Great Episode! You are doing great work and Helene Quie is always a pleasure to listen to. Her points are spot on. Best regards, David R

[@EasyMedicalDevice]

Thanks David.

[@yasminachaibi7705]

Hi Monir, This is a very good episode again. Is there any difference in the PMCF regarding class IIa and IIb ? Does the PMCF always inculed clinical investigation/validation, or litterature serach on the named device class IIb can be enought ?

[@EasyMedicalDevice]

Thanks yasmina, no difference regarding the class. PMCF should define if a study is needed. If not then literature search is possible.

[@maikarim7581]

Hello Monir , it is a good episode explaining the PMCF.
Is there any news regarding the obligations of having your PMCF acc to MDR2020 for special medical devices classes?

[@EasyMedicalDevice]

Hi Mai, If you have enough clinical data then you don’t need to complete the PMCF but to have a PMCF plan on your Technical Documentation. If you don’t have enough clinical data then a PMCF can help you to collect that. But if you have not planned a PMCF then maybe you’ll need to plan for a clinical investigation. But this can be derermined on a case by case basis. Let me know if you need support.

[@tsahistein388]

Helene was referring to MDCG guidelines and you were referring to Meddev guidelines . Can you specify to which ones were you referring? Did you refer to Meddev 2.7/1 regarding clinical evaluation?

[@EasyMedicalDevice]

Hi Tsahi, no for PMCF this is Meddev 2.12/2 rev 2

[@tsahistein388]

And any for MDCG or in-process?

[@EasyMedicalDevice]

There are but not sure when they will be released. For now we all refer to the MEDDEV but this one is related to MDD 93/42/ec.