The New MDD: 14 Things You Need to Know

In late September 2007, the long-anticipated revisions to the Medical Devices Directive (MDD 93/42/EEC) were published in Directive 2007/47/EC, which becomes mandatory in 2010. There are more definitions, software is a device, there is clarification on combination products, single-use devices, and reprocessing, administrative modifications, closer inspection of design documentation required by the Notified Body, outsourced design and manufacturing need to be more closely monitored, classification changes, IFUs must be revision controlled, records retained for five years, and emphasis on clinical data, including Class I devices.

This presentation will highlight the modifications to the directive, and what they mean for device companies, including:

• New requirements for medical devices


• Expectations for clinical data, including Class I


• New definition entries in Article 1 and Annex IX, Classification Criteria


• Added requirements to Essential Requirements Checklist, Annex I


• Clarification regarding Notified Body inspection of Design Documentation?

This audio conference is presented by Evangeline Loh of Emergo Group. To learn more, visit www.fxconferences.com.

Industry Update: The EU Paediatric Rule

The European Union's pharmaceutical legislation has an important addendum, the legislation on paediatric drugs. It requires all applicants submitting a marketing authorisation application for a new molecular entity to provide a paediatric investigation plan (PIP). This mandatory PIP will be evaluated by the paediatric committee of the EMEA. The objective of the new legislation is to develop "better medicines for children" within the EU. There are obvious consequences for the pharmaceutical industry, as the PIP must be made available during submission and paediatric trials will have to be performed.

In this audio conference we will provide the latest information on various aspects of the new legislation and how it is affecting drug manufacturers.

This audio conference is presented by Ulrich Granzer of Granzer Regulatory Consulting. To learn more, visit www.fxconferences.com.

Focus on FDA cGMP Compliance Issues

How do I make sure my facility is ready for an FDA inspection? What exactly is the FDA looking for? It is vitally important for companies within regulated industries to stay abreast of changes in FDA inspections, expectations and actions.

In this event, we will look specifically at the current focus of FDA inspections and the residual effect on actions. We will also examine changes in inspectional emphasis and reveal what inspectors are really looking for.

This audio conference is presented by David Barr of AAC Consulting/Kendle International. To learn more, visit www.fxconferences.com.

Multilingual Labels for Medical Devices — Best Practices

The device industry faces a dilemma: How can companies provide the required information in multiple languages, while making the information on their product labels readable on a variety of sizes of labels? Given the limited amount of space that's available on your labels, how can you best deal with the EU requirements for multilingual labeling?

The use of internationally recognized symbols as a substitute for text has been actively promoted to provide users with a uniform method of obtaining product information. Yet many device companies are struggling with the issues that surround multilingual label design and international symbology. This specialized audio conference will help labeling practitioners learn about best practices in the industry.

This audio conference is presented by Andres Heuberger of ForeignExchange Translations. To learn more, visit www.fxconferences.com.

Successful Medical Device Approvals in China

With over 1.4 billion people and an emerging public healthcare system, China is one of the most attractive secondary markets for medical device manufacturers worldwide. The regulatory requirements mandated by the State Food and Drug Administration (SFDA) have been evolving.

In this audio conference, our speaker will discuss the background of SFDA regulatory requirements and explain the process of registering your product in China, including specific information on how the SFDA defines and classifies a medical device, the registration dossier required by SFDA, regulatory criteria for testing and clinical trials. The presentation will also provide examples of what has helped companies succeed in achieving approvals, and discuss the latest trends in the China regulatory environment.

This audio conference is presented by Janice Ma of ChinaGate. Learn more at www.fxconferences.com.

EN 1394:2007 - A New Dawn for Human Tissue in Europe

The last 18 months has seen a huge leap forward in the regulation of human tissue products, through the publication of the Advanced Therapy Medicinal Product Regulations (ATMP). In parallel, the European Commission has expanded the directive 2004/23/EC into two technical directives, which detail requirements for ensuring public health when using human tissue from donation to distribution.

No longer will Europe be faced with a fragmented regulatory approach to human tissue products, it will have a unified system based on the free movement of human tissue across European borders.

This audio conference is presented by Phil Brown of Wright Medical. Learn more at www.fxconferences.com.

Avoiding the Top 20 Global Documentation Errors

The biggest single hurdle to a smooth globalization effort is written documentation. However, with careful planning, companies can remove communications obstacles before they arise. The technique to be described in this presentation is called "PokaYoke," a Japanese term for any device or software that can prevent process errors. Learn how you can build quality into your documentation and translation. The presentation covers the top 20 errors that a linguistic "PokaYoke" can find, monitor and correct.

John Smart has spent over two decades helping companies write technical documentation for readers in 218 countries. This presentation uses real-life examples to highlight terms, words and phrases guaranteed to fail any quality control. Attendees will be encouraged to adopt a "PokaYoke" approach to their localization and technical documentation.

This audio conference is presented by John Smart of SMART Communications. Learn more at www.fxconferences.com