27.6.-28.6.
Chicago, IL, USA

A 2-day practical & interactive training:

The New EU Medical Device regulation

This Seminar will look at what to expect when the new EU regulation is implemented: 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.
The New EU Medical Device regulation

Overview

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.

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
9am - 5pm
The new MDR main changes
  • Main updates
  • Transition periods
  • Effect on medical device manufacturers
  • Regulatory landscape
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
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
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
DAY 2
9am - 5pm
Clinical aspects and testing
  • Class I and IIa devices
  • Effect on class IIb devices
  • Class III devices
Periodic Safety Update reports
  • Content of PSUR
  • Frequency
Common Specification (CS)
  • Common Tech Specifications
Combination Products
  • Definitions
  • Requirements
  • Technical documentation
CASE STUDY 2
  • Including a walkthrough of expected outcomes for all case study exercises
This training has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
1 attendee: $ 1,495.00
5 attendees: $ 4,485.00 $ 7,475.00 You Save: $ 2,990.00 (40%)
10 attendees: $ 8,222.00 $ 14,950.00 You Save: $ 6,728.00 (45%)
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