In-Vitro Diagnostics (IVD) Manufacturers at Risk for Device Reclassification

Expert Opinion Webinar (3/27/2012 at 11:00 AM ET) Examines IVDD Revision and Device Risk 

Boston & San Francisco, March 14, 2012 

Crimson Life Sciences, a division of TransPerfect and the world’s only ISO 13485 and ISO 14971 certified translation provider, announced the latest installment of their Expert Opinion webinar series. On Tuesday, March 27 at 11:00 AM (Eastern Time), Crimson will host an informational webinar examining the serious risk classification repercussions of the upcoming In-Vitro Diagnostics Directive (IVDD) revision. Presented by Ms. Connie O’Connor, a Senior Project Manager and Notified Body auditor for DEKRA Certification, B.V. (formerly KEMA Quality), registration for this online event is free of charge. 

IVD Stakeholders Speak Out  

In February 2011, the European Commission published the results of stakeholder feedback on various aspects of the current IVDD. These recommendations from clinical laboratory associations, medical associations, manufacturers, regulators, and healthcare professionals will form the basis of the upcoming IVDD revision. Scheduled for draft publication this year, the IVDD revision is meant to remedy several challenges to the current version, including scientific and technological advancements and new business models. Perhaps most importantly, the IVDD revision is widely expected to adopt the risk-based device classification system proposed by the Global Harmonization Task Force (GHTF). 

What is Your Risk of Reclassification?

The current IVDD uses an antiquated list-based approach to device risk classification. According to industry experts, adoption of the GHTF’s risk-based device classification, together with the corresponding GHTF recommendation for conformity assessment procedures, will force many manufacturers to up-classify their products – drawing Notified Body review for the very first time. In fact, according to research from the Cannon Quality Group, 43% of IVD manufacturers currently self-certify and are therefore at immediate risk of up-classification. Of IVD makers who are currently certified to ISO 13485, approximately 70% have products that are at-risk for up-classification. 

According to Crimson President Marc H. Miller, “Ever since the introduction of ISO 14971, risk management has had a steadily growing influence in the medical device industry. The anticipated adoption of the GHTF risk classification is simply another stage in this continuing evolution.” Crimson was the first company in the world to certify to ISO 14971 and was recently issued the world’s only translation risk management patent.

Manufacturers Seek Expert Opinion 

Crimson’s Expert Opinion webinar titled “IVD Makers: What is Your Risk of Reclassification?” examines key aspects of the IVDD revision, including:

-       Overview of IVDD revision

-       GHTF classification guidance

-       Why will Notified Body involvement increase?

-       Examples of up-classified devices

The session will be led by Ms. Connie O’Connor, Notified Body auditor for DEKRA Certification, B.V. Previously, Ms. O’Connor enjoyed a 23-year career in in-vitro diagnostic device manufacturing, including full responsibility for manufacturing, product development, and operational management. 

About Crimson Life Sciences 

Crimson is a division of TransPerfect Translations International, Inc. and is the only translation practice devoted exclusively to high-risk medical devices and IVDs. Crimson is the world’s first translation firm certified to both ISO 13485 and ISO 9001 and the only translation firm certified to ISO 14971. Crimson recently received the world’s first patent for translation risk management. TransPerfect, certified to ISO 9001 and EN 15038, is the world’s largest privately held language services provider with more than 70 offices worldwide. For more information, visit  



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