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IVD Approval Process

Reading and understanding the IVD Directive may be difficult.  Dealing with the In Vitro Diagnostics (IVD) Directive is straightforward.  Eisner Safety Consultants recommends you follow our 3 step process:

First, assess your product lines to determine if you have standard or higher risk classifications.  Standard risk IVD products will require conformance with just the basic essential requirements.  Higher risk products will require conformance with one of a number of assessment routes.

Second, assess your business for the best fit with the assessment route choices for your product lines.  For example, if you have a certified quality system and product lines on the Annex II list, the fastest assessment route may involve preparing a design dossier.

Third, prepare for the assessment route you choose.   This may involve preparing new labelling for your products to comply with European symbol standards, to writing and implementing new procedures, for example, how to deal with complaints from European customers.

Most important…you’re not alone.  Eisner Safety Consultants is ready to assist you every step of the way.

You may obtain a complimentary copy of the IVD Directive by going to our resources page.