Transition IVDD to IVDR

23 maart 2020
(Hele dag)
Hotel Pullman Eindhoven Cocagne , Eindhoven
BSI Group

There are significant changes in the European legislation applicable to IVDs. The IVD Regulation (EU 2017/746) has replaced the IVD Directive (98/79/EC), and will impose new requirements on manufacturers and other Economic Operators.

This long awaited text brings a number of significant changes to the regulatory requirements for IVD manufacturers, addressing the challenges posed by the IVD Directive. The changes include a new rule-based classification system, increased scrutiny of technical documentation, and improved traceability of devices through the supply chain.

Our one day training course has been designed to introduce IVD manufacturers and other Economic Operators in the supply chain to the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR).

Who should attend?

  • Medical device manufacturers, especially if your role is in:

          • Regulatory Affairs
          • Design and Development
          • Clinical Affairs Specialists
          • Quality Management
          • Quality Assurance

  • Authorized Representatives
  • Economic Operators, including importers and distributors
  • Consultants

By the end of this course delegates will be able to define the:

  • Requirements and impacts of new IVD Regulation
  • Key aspects of the transition - from Directive to Regulation
  • Changes to responsibilities of Economic Operators
  • Significant changes introduce by the new IVD Regulation
  • Revised scope, risk-based classification, and conformity assessment
  • Revised clinical expectations
  • Managing the transition
  • New expectations for post-market activities
  • Technical documentation for compliance

Practical information

  • It's a 1-day course
  • The training and materials will be provided in English
  • Lunch and drinks are included

Price

The price of this course is € 750,-

Combination discount

Attending several medical device courses is associated with special discount:

No.

Training

Price

   1

Transition or Requirements MDR-IVDR

€750

   2

Implementing CE Marking MDR-IVDR

€1.950

Total

€2.700

Investment

Discount

Combination  training 1 + 2

€2.600

€100

For more information about combination of courses or in-house training courses, please contact Mark Leenaers via +31 20 346 07 83 or send an email to mark [dot] leenaers [at] bsigroup [dot] com

In Company Training

For more information about the in-company training or to request a quote, please contact Mark Leenaers via +31 (0)20 346 07 83 or send an email to Mark [dot] leenaers [at] bsigroup [dot] com

Datum: 
23/03/2020 (Hele dag)
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