In Vitro Diagnostic Device Regulation: How prepared are you for the changes?

March 23, 2018


The new In Vitro Diagnostic Device Regulation (IVDR) which entered into force on 25 May 2017, will replace the In Vitro Diagnostic Device (IVD) Directive 98/79/EC in May 2022.


The new IVDR is being introduced in an attempt to improve the manufacture and marketing of medical devices and address the rapid scientific and technological progress being made, any substantial deviations in the interpretation and application of the guidelines, and the lack of transparency. The growing concern that medical devices and diagnostics are not thoroughly examined before being used by the patients created the need for a new set of regulatory requirements that all EU member states must comply with.


The new regulation includes important improvements to the current system such as a new rule-based classification system for products, requirements for conformity assessment and enhancement of the current validation process. Under IVDR, classification rules apply to all In Vitro medical devices meaning that a higher percentage of companies will require certification from a notified body.


The proposed modification aims to introduce a strong, transparent, traceable and thorough regulatory framework for In Vitro diagnostic medical devices. As stated it “sets high standards of quality and safety for In Vitro diagnostic medical devices in order to meet common safety concerns…”. In light of those changes that are set to replace the previous outdated directive, manufacturers and regulatory bodies will need to create a robust plan for a smooth transition. The golden ticket to regulatory compliance and a successful passage to IVDR? Effective, proactive planning and the right regulatory expertise for your needs.


TCTC Group and Regulatory Expertise


The Regulatory Affairs Company, a division of TCTC Group, provides regulatory and medical writing services and is able to support clients throughout the product lifecycle. The RA Company is a specialist global regulatory consultancy and has extensive experience across a wide spectrum of product types, having a proven track record in assisting companies to meet their legislative requirements.


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