Industry Update: Vigilance for Medical Devices

After a few quiet years, several important European regulatory changes have occurred that will affect most medical device manufacturers. Most notably, Competent Authorities are now expecting manufacturers to have a good understanding of post-market surveillance, including vigilance. Notified Bodies and Competent Authorities alike are starting to make this a key element of their inspections and companies must be prepared.

In this presentation, Dr. Loh discusses important new revisions to MEDDEV 2.12-1 rev 5, Guidelines on a medical devices vigilance system, published in April 2007. The guidelines entered into force on January 1st, 2008.

Industry Update: Vigilance for Medical Devices was presented on 2007-06-21 and is available to download to www.fxconferences.com

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.