Press Release

DRAMATIC INCREASE IN EU MARKET SURVEILLANCE, CA VIGILANCE REPORTED AT RAPS SYMPOSIUM

• Presentation documents increased surveillance by Competent Authorities (CA's)
• CA vigilance focused on labels, IFUs & risk analysis summary
• Secret CA committee (MSOG) formed to coordinate CA vigilance findings
• Update on EU electronic labeling is available at: www.medical.crimsonlanguage.com.
  

Santa Clara, CA — June 23, 2004 — "Recent EU Regulatory Developments" was the most popular presentation at the recent RAPS West Coast Symposium. Thierry Chignon, Sr Consultant with Quintiles, reported a dramatic increase in vigilance activity by European Competent Authorities (CA's), including manufacturer's labeling, IFUs, and risk analysis information. The formation of a secret committee (MSOG) to coordinate CA vigilance activity was also reported.

Of particular interest was an update on the status of electronic labeling for the EU market. An "Electronic Labeling Update,” based on the conference presentation, is available from the website of Crimson Medical Translation: www.medical.crimsonlanguage.com.


A password is required for access. To receive a password, please email your request to: mmiller@crimsonlanguage.com

COMPETENT AUTHORITIES GAINING STRENGTH:

"Competent Authorities are gaining strength,” notes Mr. Chignon. His popular presentation at the RAPS Symposium detailed a startling increase in market control from European CA's, including:

• Increased market surveillance with a particular focus on labels, IFUs, risk analysis summaries, preclinical and clinical data.
• Increased inspections for both clinical trials and marketed devices.

By way of example, Chignon provided 2002/2003 surveillance data for AFSSaPS (CA for France) that included 98 separate lab tests and 80 inspections of device manufacturers, leading to several removals from market. Also cited were 229 complaints (80% from competitors) in the British market, which led to 171 separate manufacturer inspections.

POOR TRANSLATION JEOPARDIZES ISO 14971 RISK MANAGEMENT ACTIVITIES:

In addition to implications for MDD and IVDD compliance, translation also has critical implications under the new ISO 14971 risk management standard. Under ISO 14971, all residual risk must be mitigated (at minimum) through labeling and IFUs. Satisfying this requirement through the use of English documentation is straightforward. However, companies may jeopardize their ISO 14971 compliance in international markets if their translated labeling and IFUs are inaccurate.

CA VIGILANCE COORDINATED BY SECRET COMMITTEE:

Perhaps most worrisome from a manufacturer's point of view, is the formation of the Market Surveillance Operations Group (MSOG). This confidential committee, for which there are no official agenda or minutes available, was established to coordinate vigilance findings among the various CA's.

In particular, Chignon mentioned poor labeling as one area being specifically targeted for examination. "Poor labeling can lead to a finding and place a manufacturer on a CA's Vigilance List,” stresses Chignon. "This is exactly the type of information that is shared among CA's at the MSOG meetings.”

Symposium attendee, Marc Miller, agrees. "The risk management requirements of ISO 13485:2003 and ISO 14971, plus increased CA scrutiny, mean that EU labeling is a critical regulatory consideration. Labeling translation for the EU is considered an 'important outsourced service' by Notified Bodies, specifically because of this regulatory risk.”

As Crimson’s CEO, Miller understands the regulatory consequences of labeling translation. In addition to ISO 9001:2000 certification, his company has received official Notified Body support for its innovative use of the SAE J2450 translation quality metric. Based on this linguistic QA methodology, Crimson is reportedly the only translation company in the world to hold an official endorsement to ISO 14971:2000 (risk management).

The complete electronic version of Chignon's presentation, plus other valuable Symposium information will be available from the RAPS bookstore in July (www.raps.org)

UPDATE ON ELECTRONIC LABELING FOR THE EU:

Given the large number of EU languages (including the Accession Countries) and the difficulties they present for product labeling, Chignon's presentation gave special attention to the current status of electronic labeling.

An update summary is available from Crimson's website:

www.medical.crimsonlanguage.com

A password is required for access. To receive a password, please email your request to: mmiller@crimsonlanguage.com

Said Chignon, "Currently, an industry position has been provided, but no official EU position has been taken. While there is general support from the Commission, it is restricted to devices that are destined for 'professional use' only.”

VALUABLE MDD, IVDD, ISO & OTHER REGULATORY RESOURCES AT:

In addition to the "Electronic Labeling Update," there are many other valuable resources at the Crimson Medical Translation website: www.medical.crimsonlanguage.com.

Also available for download are an IFU Symbols Library (350 electronic labeling symbols), an update on the status of Electronic Labeling for the EU, Jeffrey Shaul's ISO 14971:2000 Implementation Guidance, ISO 13485:2003 Outsourcing Guidance, IVDD Danger-Phrase translations, Ed Kimmelman's Quality System Matrix, EU Notified Body Secrets, and Legal Guidance for EU Language Requirements. All items require a password. Requests for access password can be emailed to: mmiller@crimsonlanguage.com

About Crimson Medical Translation

Crimson Medical Translation, founded in 1992, provides "Expertise in Translation for the Medical Technology Industries." It is the only translation company in the world to be certified to the ISO 13485:2003 and ISO 9001:2000 quality standards. The company's work has been recognized as MDD compliant by an EU Notified Body. Crimson has also received official Notified Body recognition for its innovative application of the SAE J2450 translation quality metric. Extensive use of the metric enabled the company to achieve the first (and only) endorsement to ISO 14971:2000 by a translation company.

The firm's founder, Marc H. Miller, provides management guidance. Mr. Miller holds a degree in languages and literature from Harvard University and an MBA from the Scottish Business School in Stirling, Scotland. While working as a Senior Research Fellow with the international strategy consulting firm S.I.A.R., he authored strategic assessments for European and US medical technology firms.

Crimson's specialized approach to medical technology translation has been featured in industry publications such as Medical Device & Diagnostics Industry and Medical Products Outsourcing.

FOR MORE INFORMATION & CLIENT REFERENCES LETTERS, PLEASE VISIT:

www.medical.crimsonlanguage.com