How to write your Performance Evaluation [IVDR 2017/746]

In this episode, I have invited Hakan Inan from Requalite to help us understand the situation for In-Vitro Diagnostic device manufacturers and also on how to create a Performance Evaluation Report.
In this episode, Hakan will provide you all the elements so that you have a good understanding of the Performance Evaluation process. This will include also so the comparison to the EU MDR legislation and define if there are some commonalities. The IVDR industry should start urgently its transition to the EU IVDR 2017/746 and most importantly we will need more Notified Bodies to help these companies to get certified.
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► Who is Hakan Inan?
Hakan Inan is the founder and the managing director of Requalite GmbH, Medical device compliance consulting company, with a special focus on Medical writing activities for Performance and clinical evaluation reports as per MDR and IVDR. Hakan holds a PhD in Nanotechnology and has developed in vitro diagnostic devices for cancer applications at Medicine Faculty-Stanford University. Requalite provides support to Medical device and In vitro diagnostic device companies in their compliance journey by designing and creating Performance and Clinical Evaluation Reports. Requalite has a strong team of experts, all with PhD degrees in the scientific fields including immunology, hematology, oncology, neurology, and cardiovascular diseases, etc.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert Specialised in Quality and Regulatory Affairs. He decided to quit his corporate job to start EASY MEDICAL DEVICE. He is now providing support to the Medical Device industry by educating people with his Blog, Podcast, UA-cam channel and also helping them through consulting, coaching, and training. He decided to open an office in the UK to be able to support his customers that would need a UK Responsible Person. Easy Medical Device is becoming the one-stop shop for Medical Device Industry.
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► Links from the Video
■ Requalite Website: www.requalite.com
■ Linkedin: / hakaninan
■ Linkedin page: / requalite-gmbh
■ Document Links for PER:
☺ www.imdrf.org/d...
☺ www.imdrf.org/d...
☺ www.imdrf.org/d...
☺ www.medtecheur...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#easymedicaldevice #medicaldevice #regulatorycompliance

[@bepelo9014]

Thank you for your video. However every PER videos I have seen include examples of IVDs that measure a clinical condition. But what happens for IVDs that do not measure/detect a clinical codition i.e. Blood grouping reagent?

[@metecongmbh2728]

Principally, the same requirements for performance evaluation apply to all kinds of IVDs. The IVDR states that
“the benefit of in vitro diagnostic medical devices lies in providing accurate medical information on patients, where appropriate, assessed against medical information obtained through the use of other diagnostic options and technologies, whereas the final clinical outcome for the patient is dependent on further diagnostic and/or therapeutic options which could be available.”
Therefore, the clinical benefit of an IVD detecting a blood grouping reagent is the detection of the blood grouping agent. To show the clinical performance of such a device you could e.g. compare the results of the assay with another already CE-marked assay having the same intended use or another gold standard method for that purpose if available.
I hope this information is helpful to you.
Best regards
Dr. Sandra Reuter, Project Manager IVD at Metecon GmbH
www.metecon.de/en/