In Vitro Diagnostics (IVD)

Manufacturers continue to develop and release faster, more accurate In Vitro Diagnostics (IVD) devices, defined as devices made to analyze human body fluids, such as blood or urine, in order to provide critical information for diagnosing, preventing and treating diseases.

While the industry has faced consolidation and recent economic difficulties, the aging population, demand for healthcare and emerging markets point to a healthy prognosis for the future of such testing.*

Challenges

Offering IVDs in the European Union (EU) requires compliance with the In-Vitro Diagnostic Directive (IVDD; directive 98/79/EC), which lists devices that require specific assessments into two categories: List A (e.g., blood grouping, HIV screening) and List B (e.g., HLA grouping; detection of Chlamydia, rubella; monitoring blood glucose). 

Similar to the Medical Device Directive (MDD), the IVDD includes requirements that govern the device's performance and manufacturing, market placement and demands on safety and quality.

Certain IVDs must meet Common Technical Specifications published as the Commission Decision (2002/364/EC; since modified by 2009/886/EC).  As the marker tested by the IVD product may evolve, especially regarding viral contamination, the manufacturer must track evolutions of these markers.

LNE/GMED has the necessary expertise with In Vitro Medical Devices to perform a thorough, relevant assessment based on your products' IVD status.

IVD Manufacturers: Avoid pitfalls that can delay or derail CE Marking
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Advantages

LNE/G-MED is recognized to assess Active Implantable Medical Devices and has significant experience certifying a wide range of devices for CE Marking, often in conjunction with ISO 13485, CMDCAS, third party FDA inspection and other certificates, to save the time and cost of multiple audits.

You also benefit from:

• Local Washington, DC based office with qualified auditors throughout North America to increase convenience and minimize travel costs
• Simultaneous certification for CE Marking, Quality Management Systems (ISO 9001, ISO 13485, ISO 14001) and other standards often performed by a single, highly-qualified auditor, to save you time and expense
• Widely recognized LNE/G-MED expertise as a European Notified Body (CE 0459), as an Accredited Certification Organization by France's accreditation body COFRAC, as a Registrar accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and recognized by Health Canada and as a Third Party Accredited Person by the U.S. FDA
• Added services, such as product testing (EMC, electrical, mechanical, CB Scheme), product certification, pre-assessment audits and fast-track or onsite review for CE Marking

Find Out More

LNE/G-MED America offers in-person, online and other customized training on a wide range of certification and quality topics. For details, check out our training schedule or request a customized program.

Contact LNE/G-MED America

• For proposals or other service questions: contact customer service
• Ask our experts to submit specific questions to our technical team

 

*Source: Richard Park, The Year in IVDs, IVD Technology, October 2009: online