The New EU Medical Device regulation Seminar

Global Compliance Seminars

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.

Course Description

Overview:

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.

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.

Areas Covered in the Session:
- The updated Regulation
- Implementation dates and transition
- Main changes and products affected
- Effect on medical device manufacturers
Who will benefit:
- Clinical Trial Managers
- Regulatory Affairs
- Medical Officers

Agenda:

Day 1 Schedule

Lecture 1 (90 Mins):

The new MDR main changes

Main updates
Transition periods
Effect on medical device manufacturers
Regulatory landscape

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

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

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

Lecture 1 (90 Mins):

Clinical aspects and testing

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

Lecture 2 (90 Mins):

Periodic Safety Update reports

Content of PSUR
Frequency

Lecture 3 (30 Mins):

Common Specification (CS)

Common Tech Specifications

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

Speaker:

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.

Credits Available

Course "The New EU Medical Device regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

More Seminar Information

Global Compliance Panel
Summary	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.
Delivery Method	Seminar
Who Should Attend	Clinical Trial Managers, Regulatory Affairs, Medical Officers