Tag Archives: IVDD

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

IVDD – Article 1

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

There are four fundamental differences associated with Article 1 of the IVDD versus the MDD. It is incumbent upon device manufacturers to comprehend these fundamental differences along with definitions specific to the IVDD to support the successful entry of in-vitro devices into the European market.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

IVDD – An Introduction

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

This series of articles will be premised on the IVDD.The primary takeaway from this week’s edition is that there are significant similarities between the MDD and the IVDD. However, there are also several differences that make the IVDD appear quirky. With revisions to the IVDD looming on the horizon, ongoing compliance with this Directive will continue to be a challenge.

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