MDR & Drug-Device Combination Products with Theresa Jeary
This episode will be really interesting for the pharmaceutical companies that are producing Drug-Device combination products as it explains the consequence of EU MDR Article 117 for their products.
For all projects that are ongoing, you need to consider the new requirements coming from EU MDR as this is amending the 2001/83/EC Medicinal Product Directive.
Theresa Jeary will be my guest during this episode, and her experience with Drug-Device products and as a former Notified Body assessor will help you understand what are the deliverables you should provide now.
We will also discuss the importance of the Notified Bodies during this process as the pharma industry is not really used to deal with this kind of third party entity.
Finally, Theresa prepared a document that you can download below. It will provide you with a summary of the situation for Drug-Device combination products when it comes to the EU MDR.
Who is Theresa Jeary?
Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has been involved in the development of many commercially available medicinal and medical device products.
Theresa has over 12 years of Notified Body experience, initially at BSI as a technical expert for devices with ancillary medicinal substance and she held the position of Head of Notified Body at the UK NB LRQA until January 2019.
Her core area of technical expertise is in the combination product area and Theresa now works as a consultant to the Pharmaceutical and Medical device sectors supporting Companies in meeting regulatory requirements. Theresa is a frequently invited speaker on the medical device legislation and combination products.
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…
Links
- Theresa Jeary LinkedIn Profile: https://www.linkedin.com/in/theresa-jeary-09bb7226/
- Template Drug-Device Technical Documentation: https://school.easymedicaldevice.com/product/drug-device-tech-doc/
- Download Presentation: https://mailchi.mp/easymedicaldevice/article_117
- How to classify a Medical Device: https://easymedicaldevice.com/new-eu-medical-device-classification/
- FAQ EMA Article 117: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
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