EU MDR / IVDR Readiness: Implementing the New Regulations
The objective of this seminar is that participants will take away either a confirmation of the transition plan they have compiled and for those yet to embark on planning their response that they will feel sufficiently informed to return to their businesses and develop a transition plan.
By June 2017 it is anticipated that the EU Parliament will have legislated MDR and that the MedTech will have embarked on the transition from MDD, to ensure compliance by the end of the permitted 3-year timeframe set out.
The seminar consists of two sessions. Initially we will examine the changes incorporated into the new EU MDR via a selection of product case studies. Not only will we address the specifics of the changes, we will discuss the types of solutions required to close the gaps.
In the second half of the session we will use the case studies as the basis for a discussion on structuring a transition plan. Participants will engage in building an outline plan in the first instance and to use the feedback as a means of illustrating many of the critical success factors to ensuring a sustainable transition.
Who should participate
A regulatory led delegation who require other functional leaders (Product Development, Quality, Medical Safety, Supply Chain etc.) to understand EU MDR and what it means for their business.
An EU MDR project team who may have completed the Gap Impact Assessment work and are considering how to structure the transition plan.
Eithne Lee has 20+ years of consulting experience, advising Global Life Sciences clients; Pharmaceuticals, BioPharmaceutical, Medical Devices and Diagnostics. She contributes as a subject matter expert in operational matters across the value chain; R&D, Manufacturing and Supply Chain, Commercial.
Ben Jacoby is an experienced regulatory consultant who has worked with clients in the diagnostic, medical device and pharmaceutical industries. He provides regulatory and strategic guidance on EU and US issues to clients. Core competencies include: Clinical studies; EU legislation including IVD's, companion diagnostics and medical devices; EU legislative requirements for instruments; and classification of devices. With more than 25 years of experience in regulatory affairs, he was European-authorized representative at Ortho-Clinical Diagnostics (a Johnson & Johnson company at the time).
Søren Holck holds almost 30 years’ experience as a senior manager at Coloplast within Supply Chain, IT, Quality Management and Regulatory Compliance. In his current position Søren is assuming overall responsibility on Coloplast MDR response.
Session 1 – Eithne Lee, Associate Partner Advisory Life Sciences, EY &
Ben Jacoby, Consultant, Your Encore
12.00 - 12.30 Sandwich & networking
12.30 - 13.00 Welcome and Introduction
13.00 - 14.30 EU MDR – the new norm
- Med Dev: Class III / Class IIb (Implantable/non-implantable)
- In-Vitro Diagnostics: Class D / Class C
14.30 - 14.45 Coffee break
Session 2 - Eithne Lee, Associate Partner Advisory Life Sciences, EY &
Søren Holck, Director Global Quality - Compliance & Systems, Coloplast
14.45 - 15.45 Transition Planning
- Build a transition plan
- Critical success factors for consideration
15.45 - 16.15 Conclusions and wrap-up