Intertek Assists Medical Device Manufacturers to Meet EU Regulation Changes
With less than 9 months to go before regulatory changes take effect, faster Notified Body reviews reduce the risk of lost sales
Boxborough, MA, July 02, 2009 --(PR.com)-- 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," said 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."
Contacts
For further information, please contact:
Stacey Corbin
Global Marketing Manager, Systems Certification
Telephone: +1 978 929 2116
E-Mail: stacey.corbin@intertek.com
* Directive 2007/47/EC was published in the Official Journal of the European Union on 21 September 2007. This new Directive amends the existing EU requirements for medical devices (93/42/EEC), active implantable medical devices (90/385/EEC), and biocidal products (98/8/EC). The full text is available at: http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_247/l_24720070921en00210055.pdf
**A Notified Body is a conformity assessment organization that has been approved by the European Commission. The CE Mark, when applied to a product, indicates the product’s conformity with the appropriate EU Directive.
###
About Intertek
Intertek (ITRK.L) is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection, to testing, quality assurance and certification, Intertek people are dedicated to adding value to customers' products and processes, supporting their success in the global marketplace. Intertek has the expertise, resources and global reach to support its customers through its network of more than 1,000 laboratories and offices and over 23,000 people in more than 100 countries around the world. For more information, visit www.intertek.com.
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," said 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."
Contacts
For further information, please contact:
Stacey Corbin
Global Marketing Manager, Systems Certification
Telephone: +1 978 929 2116
E-Mail: stacey.corbin@intertek.com
* Directive 2007/47/EC was published in the Official Journal of the European Union on 21 September 2007. This new Directive amends the existing EU requirements for medical devices (93/42/EEC), active implantable medical devices (90/385/EEC), and biocidal products (98/8/EC). The full text is available at: http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_247/l_24720070921en00210055.pdf
**A Notified Body is a conformity assessment organization that has been approved by the European Commission. The CE Mark, when applied to a product, indicates the product’s conformity with the appropriate EU Directive.
###
About Intertek
Intertek (ITRK.L) is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection, to testing, quality assurance and certification, Intertek people are dedicated to adding value to customers' products and processes, supporting their success in the global marketplace. Intertek has the expertise, resources and global reach to support its customers through its network of more than 1,000 laboratories and offices and over 23,000 people in more than 100 countries around the world. For more information, visit www.intertek.com.
Contact
Intertek
Stacey Corbin
+1 978 929 2116
www.intertek-sc.com
Stacey Corbin
+1 978 929 2116
www.intertek-sc.com
Contact
Categories