Clinical Evaluation of Medical Devices in the EU

is being presented by Anthony L. Fitzhugh, M.D., Project Manager/Lead Auditor, with TUV SUD America Inc and airs on Thursday, December 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Annex X of the Medical Device Directive (EC Directive 93/42/EEC) requires that a manufacturer who seeks to place a medical device on the market in the EU first conduct and document in the technical file/design dossier a clinical evaluation that fully evaluates the safety and efficacy of the device. An amendment (2007/47/EEC) to the Medical Device Directive—published in 2007— has made this requirement even more stringent than in the recent past. The clinical evaluation must now be documented in such a manner that this section of the file comprises a standalone document. Moreover, all manufacturers must actively maintain their compliance with the aforementioned clinical requirements as well as post-market clinical follow-up—unless it can be shown to be not necessary.

As a result of these changes, those working in regulatory affairs must ensure that they have the proper expertise and strategy in place to allow their company to comply with these requirements prior to and after placement of their medical device on the EU market. This audio conference presentation covers the EU regulatory framework for meeting the revised clinical requirements, as well as strategies for maintaining the clinical data section of the technical file or design dossier.

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.