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Regulation proposals of the European Commission Background

In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject.The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

This Seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

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Why you should attend:

Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.

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Areas Covered in the Session:

• The updated Regulation
• Implementation dates and transition
• Main changes and products affected
• Effect on medical device manufacturers

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Who will benefit:

• Clinical Trial Managers
• Regulatory Affairs
• Medical Officers

Day 1 Schedule

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Lecture 1 (90 Mins):

The new MDR main changes

• Main updates
• Transition periods
• Effect on medical device manufacturers
• Regulatory landscape

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Lecture 2 (90 Mins):

Notified Bodies under the New MDR

• Effect on NBs
• When will NBs begin conformity assessment against the new Regulation?
• Main effect on medical device manufacturers

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Lecture 3 (90 Mins):

Impact of the MDR on Quality Management Systems (QMS)

• When do I need to update my QMS?
• What main points need to be considered?
• Effect on medical device manufacturers

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Lecture 4 (90 Mins):

Technical Documentation

• Class I and IIa devices
• Effect on class IIb devices
• Class III devices

CASE STUDY 1 - Including a walkthrough of expected outcomes for all case study exercises

Wrap up of day 1 & Q&A's

Day 2 Schedule

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Lecture 1 (90 Mins):

Clinical aspects and testing

• Class I and IIa devices
• Effect on class IIb devices
• Class III devices

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Lecture 2 (90 Mins):

Periodic Safety Update reports

• Content of PSUR
• Frequency

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Lecture 3 (30 Mins):

Common Specification (CS)

Common Tech Specifications

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Lecture 4 (90 Mins):

Combination Products

• Definitions
• Requirements
• Technical documentation

CASE STUDY 2 - Including a walkthrough of expected outcomes for all case study exercises

Wrap up of day 2 & Q&A's

 

Salma Michor

PhD, MSc, MBA, CMgr, RAC
 

Salma Michor is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.

Please contact Marilyn Turner: Phone: +1 929 900 1853  Email: marilyn.turner [a] nyeventslist.com for registrations