Paul & Elisabeth Merage Foundation | Andre & Katherine Merage Foundation

Professor

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Jaap L. Laufer

Jaap L. Laufer

Vice President

Regulatory and Clinical Affairs, EMERGO GROUP

Class Overview

This Module will cover the main aspects of the life-cycle of medical technology products, including patent protection, design and development, manufacture and distribution, market approval or registration, and reimbursement and pricing attributes, all of it in conjunction with the clinical data available and generated to support product indications, or intended use and claims. In addition, exit strategies for start-ups and their implications for the above subjects will be broached.

The aim of the presentation is to focus on the few single most important factors that determine the success or failure of a novel medical or drug-device combination product in the US and Europe, as well as other major jurisdictions.

Dr. Laufer intends this to be an interactive session. Therefore, the presentation will allow the audience to interject and to pose questions, preferably of general character. Afterwards the speaker will be happy to expand on questions that may be specific to any particular company or participant.

We will also briefly explore the most important ins and outs of clinical studies, as well as critical success factors. Lastly a brief overview will be given of the new  EU Regulations on MDs and IVDs.

References & Guidance:

http://www.fda.gov/MedicalDevices/default.htm- 

Do it by Design, FDA Guidance- http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm094957.htm

Blood products, Europe

https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety (CE-marking process, combination and borderline products) 

Drug Device Borderline Products -

https://www.gov.uk/guidance/decide-if-your-product-is-a-medicine-or-a-medical-device  

Advanced Therapeutic Medicinal products (ATMP) –

http://english.cbg-meb.nl/about-meb/contents/regular-consultations/committee-on-atmp  

Medical Devices Regulations (MDRs) in Europe

http://eur-lex.europa.eu/legal-content/ENG/TXT/PDF/?uri=CELEX:32017R0745&from=EN

MHRA UK guidance to the new MDRs

https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr 

 

EMA

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000296.jsp&mid=WC0b01ac058007f4bc 

Drug Eluting Stents (example of EMA guidance for Combination Products)  – http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003278.pdf