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Introduction to the In-Vitro Diagnostic Regulation (IVDR)


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Who should attend?

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

Details

Course Overview

The new In-Vitro Diagnostic Device Regulation (EU) 2017/746 came into force in May 2017 with a transition period of 5 years. The IVD Regulation is significantly different from the IVD Directive, including changed classification rules and requirements for conformity assessment. It is intended to strengthen the current approval system for in-vitro diagnostics, making substantial changes to the existing IVD Directive (98/79/EC) legislation.

The IVD Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) rules for classification which, for the first time, takes patient impact into consideration. This change to the classification system will have an impact on all manufacturers of IVDs. The majority of IVDs are currently self-declare devices but under the new regulation about 80% of IVDs require some form of conformity assessment by a Notified Body.

Practical workshops over the two days will help consolidate the information provided.

Prices

GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% En

Contact

Leigh White
info@management-forum.co.uk

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