Introduction to the In-Vitro Diagnostic Regulation (IVDR)

  • 13-14 May 2021
  • 04-05 Nov 2021
  • London, United Kingdom

Description

Introduction to the In-Vitro Diagnostic Regulation (IVDR) is a course dedicated to requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746.

Introduction to the In-Vitro Diagnostic Regulation (IVDR) covers topics such as:

  • How the role of the Notified Body will change under the IVD regulation
  • The new IVD regulation
  • Planing labelling requirements and strategies
  • The requirements of the Technical Documentation for an IVD
  • How IVDSs are classified
  • The key changes to ISO13485
  • The vigilance and Post Market Surveillance (PMS) requirements for IVDS
  • The requirements for clinical evidence

Introduction to the In-Vitro Diagnostic Regulation (IVDR) brings together:

  • Persons responsible for regulatory compliance
  • Regulatory affairs personnel
  • Those responsible for OEM/Subcontractor control of IVDs
  • Quality assurance professionals
  • Economic operators, importers, distributors

Introduction to the In-Vitro Diagnostic Regulation (IVDR) will be held in London, United Kingdom on 13-14 May 2021.

Venue

  • London, United Kingdom

More Details

Prices:
1499 Pound Sterling
Organizer:
Management Forum
Websites:
(13-14 May 2021)
(04-05 Nov 2021)

Prices are for evaluation only.

Future Events

  • Introduction to the In-Vitro Diagnostic Regulation (IVDR) - 13-14 May 2021, London, United Kingdom (76570)
  • Introduction to the In-Vitro Diagnostic Regulation (IVDR) - 04-05 Nov 2021, London, United Kingdom (76588)
  • Introduction to the In-Vitro Diagnostic Regulation (IVDR) - May 2022, London, United Kingdom (76589)

Past Events

  • Introduction to the In-Vitro Diagnostic Regulation (IVDR) - 03-04 Nov 2020, The Rembrandt Hotel, London, United Kingdom (84399)
  • Introduction to the In-Vitro Diagnostic Regulation (IVDR) - 05-06 May 2020, The Rembrandt Hotel, London, United Kingdom (83782)

Important

Please, check the official event website for possible changes, before making any traveling arrangements

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