Intertek Assists Medical Device Manufacturers Meet EU Regulation Changes

Intertek, a leading global provider of quality and safety solutions, is working with medical device manufacturers who are currently under pressure to stay compliant under widespread changes to European Union (EU) regulations.

The EU has published a revision to its Medical Device Directive (MDD)*, which defines essential quality and safety requirements for all medical devices imported, sold, and used in the EU.  The changes, which become mandatory on 21 March 2010, represent the first significant revisions to the MDD in fifteen years.  Some of these changes – such as new requirements for devices containing phthalates, and an added connection to the Machinery Directive – are major departures from the status quo.

Many manufacturers are scrambling to effectively implement the new requirements before the March 2010 deadline.  Most medical devices require the approval of a Notified Body before they can bear the CE Mark. Part of this approval process is a technical file review, during which the Notified Body reviews the device’s full construction details as provided by the manufacturer.  However, Notified Body review times – three months or more are not uncommon – may threaten manufacturers’ continued compliance. 

Intertek helps manufacturers by providing a standard turnaround time of thirty calendar days on Notified Body technical file review.  In addition to its Notified Body services, Intertek provides medical device manufacturers with a full suite of safety and regulatory solutions including management systems auditing, electrical safety testing, environmental compliance services, consulting, and analytical services.

“The changes to the Medical Device Directive are comprehensive, and many of our clients are feeling overwhelmed right now.  The key risk is that if the changes aren’t factored-in far enough in advance, there can be disruption to product sales and market presence,” says Erik Landgren, Intertek’s executive director for auditing and systems certification services in Europe, Middle East, and Africa.  “Our approach is to deliver the fastest and most reliable review services, so our clients can have peace-of-mind that they will continue to bring their innovative products to the European market without disruption.”

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