Assessing Conformity

Tuesday, November 02, 2010

Conformity assessment sounds like an awful daunting processes. But it's actually not so hard to understand or even work through.

Conformity assessment is the process by which your product demonstrates conformance to a particular standard, directive or requirement. For the IVD Directive, the conformity assessment route for your product is determined by your intended use and its risks to personal and public health.

The IVD Directive provides several conformity assessment routes to demonstrate conformance. These are summarized in the table below.

Conformity Assessment Routes

Annex III
EC Declaration of Conformity - Self-Certification Route

Conformity assessment route where a manufacturer declares conformity of his products with the IVDD. All “ordinary” IVD products can be CE-marked using this “self-certification” route.

Annex IV
Full Quality Assurance System

Manufacturers must submit an application for examination of the design dossier to their notified body for review and approval.

Annex V
EC Type-Examination

The Notified Body will examine and test representative samples of the product and certify that the device meets the applicable essential requirements.

Annex VI
EC Verification – Batch Verification

The Notified Body will examine and test every individual product or samples taken from a batch on a statistical basis.

Annex VII
Production Quality Assurance

The Notified Body will audit and certify the manufacturer’s production quality system.

Annex VIII
Procedure for Performance Evaluation

Manufacturers attest conformity to the performance evaluation requirements.

The above conformity assessment routes are similar to the FDA premarket registration requirements, which are also determined by the intended use and the risk to personal and public health. Lower risk devices require conformance to less than higher risk devices.

Your product may require conformance with more than one conformity assessment route. Work with your authorized representative and notified body to choose the best conformity assessment route(s) for inclusion in your regulatory strategy.

Tags: Best Practices, EU, IVD

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