Evangeline Loh and Stewart Eisenhart With 2011 half over, how many of us are still adhering to ou

Evangeline Loh and Stewart Eisenhart

With 2011 half over, how many of us are still adhering to our New Year’s resolutions? If statistics are to be believed, few—if any are sticking to their guns. For the lucky few who develop objectives for which there are no metrics, who’s counting?

With the prospect of more prescriptive regulatory requirements on the horizon as part of the European Union’s recast of its Medical Devices Directives, European notified bodies have developed and made public a voluntary code of conduct in an effort to improve their system from within—and fend off having to comply with more heavy-handed rules from the European Parliament, Council and Commission.

As readers will recall from previous columns, notified bodies are third-party entities “notified” to perform certain activities by each European Union member state. (Notified bodies only are involved in certain classifications of medical devices. And, when involved in a certification process, a notified body’s four-digit number will appear with the CE Mark on a device’s labeling.) Periodically a complete list of notified bodies is published in the Official Journal of European Communities. This information also is cataloged in a searchable database on the European Commission website. Hence, a competency or directive can be selected; a procedure, article or annex can be selected; and then a search can be performed to identify notified bodies.