Why are we not Discontinuing your Products?
This is really a good question. Sometimes, we are looking at the portfolio of some companies and ask “How many products on this portfolio are sold in less than 5 units per year” One company with 1200 references showed me an excel sheet with 500 references that are available but with really low volume of sales. This cost stock, regulatory update work, continuous improvement… So let’s talk with Alexandros Saavidis about Discontinuation and I hope this will convince you to embrace this practice.
Who is Alexandros Savvidis?
Alexandros Savvidis is a Senior Medical Device Specialist active for more than 17 years in multiple areas including Regulatory Affairs, Quality Management, R&D, Sales, Technical Support & Analysis. After his studies in Biomedical Engineering, he has worked in the medical devices as also the pharma packaging industry across Europe in Germany, Switzerland, Netherlands, UK, and Greece. He has organized and contributed as an RA Specialist to various successful international certifications of medical devices of all classes. Alexandros has gained one overall experience and deep understanding through his various roles in the full norm compliant development and certification process, like many other aspects like GMP, quality, risk management, vigilance, or clinical evaluations. He has worked on small, middle-size companies alone or as a team member, or even on cross-functional teams of Life Science Giants. In the last years, his main focus is the implementation of MDR requirements and updates
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies 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, podcasts, online courses…
Link
- Discontinuation process Download: https://mailchi.mp/easymedicaldevice/discontinuation
- Alexandros Linkedin Profile: https://www.linkedin.com/in/alexandrossavvidis/
4 Replies to “Why are we not Discontinuing your Products?”
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Dear Monir, Alexandros,
how is it possible to evaluate the risks of a very old device (not compliant to new safety standards), which is not on notified body list anymore? Are very benign PMS data a good reason to say that it is still safe?
How do you see the situation when the MD to work needs an accessory (still CE marked) and not only spare parts? So, one part is defunct to regulators, and another not.
Thank you for the interesting discussion. For sure I realized that we need a discontinuation SOP. So thank for additional work 🙂
Hi Christian, if your device is not anymore compliant to the regulation ( even if the accessory is compliant) you need to first perform all the needed analysis to get all the needed documentation Updated. Yes the history of the product may help if this is not really old data. But you will need to redo Clinical Evaluation Report, PMS plan, PMCF plan, and show to the regulators that your product is still safe and performant.
But when a product is not anymore registered or certified, for Notified Bodies it‘s like this is a new product. So you have to restart moatly everything from zero.
Thank you for another really useful podcast! I wondered if you had every come across a situation where a device was ‘de-classified’ so it was decided that actually it is not a medical device and had been wrongly classified in the past? We have some class 1 devices where I think this might be the case and now with the increasing MDR requirements it is becoming clear that they are very difficult to fulfill when the device has no clear, direct clinical benefit. Is there a process for declassifying a device?
Hi Jenny, thanks for your message. Regarding de-classification as these products are class I you may need to reach to the authority where they were registered to then tell them that you are not considered these products as medical device anymore with your justification and ask them to remove them from there list. You then need to check which other legislation is in scope and fulfill the requirements of this new regulation.