New EU Medical Device Regulation | Updated Regulation 2018

GlobalCompliancePanel

Event

In Chicago (USA)

£ 1,195.36 VAT inc.

*Indicative price

Original amount in USD:

$ 1,495

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Description

  • Type

    Event

  • Location

    Chicago (USA)

  • Class hours

    9h

  • Duration

    2 Days

Regulation proposals of the European Commission Ba

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.

Facilities

Location

Start date

Chicago (USA)
See map
Hilton Garden Inn O'Hare 2930 S. River Road Des Plaines, IL 60018 Phone: +1 847-296-8900, 60018

Start date

On request

About this course

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

Clinical Trial Managers
Regulatory Affairs
Medical Officers

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Reviews

Subjects

  • Medical
  • Medical training
  • Pharma
  • Pharmacology
  • Fda
  • Medical Research
  • Regulation Law
  • Safety Management
  • Product Quality
  • Healthcare

Teachers and trainers (1)

Salma Michor

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 t

Course programme

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

See related categories

New EU Medical Device Regulation | Updated Regulation 2018

£ 1,195.36 VAT inc.

*Indicative price

Original amount in USD:

$ 1,495

The best Medicine courses

See all

See all