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Global Medical Device News

Europe |

Guidance on sampling requirements for Class IIa and IIb devices set forth in EU Directive 2007/47/EC

Directive 2007/47/EC becomes effective March 21, 2010 and will require Notified Bodies to review a sample of Technical Files for Class IIa and Class IIb devices. The most frequent question from companies with numerous devices has been: What is an appropriate sample?

While manufacturers should receive notice directly from their Notified Body, we wanted to outline the guidance issued by the Notified Body Operations Group (NBOG) to Notified Bodies in July of 2009. The Guidance on Notified Body’s Tasks of Technical Documentation Assessment on a Representative Basis addresses...

Source | Stewart Eisenhart
Oct 5, 2009
United States |

FDA Hosts Public Hearing to Address the Internet and Social Media and how they Relate to Product Regulation

The FDA is holding a public hearing on November 12 and 13, 2009 from 8am to 5pm each day to discuss the increasing challenges that social media and the internet have presented to product regulation. The hearing will be at the National Transportation Safety Board Conference Center in Washington, D.C. In addition to the public meeting, the FDA will also accept comments (electronic and hard copy) until February 28, 2010. 

By mid December, the transcript for the meeting will be available under the Division of Dockets Management, available...

Source | Emergo Marketing
Sep 23, 2009
Canada |

Health Canada to require STED format for Class 3/4 medical device submissions

Health Canada just put out an official notice that they are going to require the STED format for most Class 3 and Class 4 medical device license submissions by July 2010.

Source | Emergo Marketing
Aug 13, 2009
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MHRA publishes updated guidance document for clinicals conducted in UK

In July, the MHRA issued an updated guidance document on clinical investigations to be carried out in the UK.

Source | Emergo Marketing
Aug 12, 2009
United States |

Redesigned US FDA website an improvement

The US FDA recently launched a new website, with a new look and organization.

Source | Emergo Marketing
Jun 25, 2009
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European Commission issues important guidance document on 2007/47/EC

The EU has just released an important guidance document that should be read by every company selling medical devices in Europe.

Source | Emergo Marketing
Jun 11, 2009
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European Commission issues interpretation of Directive 2007/47/EC

The European Commission has issued an interpretative document (dated 5 June 2009) of Directive 2007/47/EC (which amends the Medical Devices Directive MDD 93/42/EEC and the Active Implantable Medical Devices Directive AIMDD 90/385/EEC).

Download it here.

As you are probably aware, EU Directive 2007/47/EC modifies the Medical Devices and Active Implantable Medical Devices Directives, and must be applied starting 21 March 2010. The European Commission...

Source | Stewart Eisenhart
Jun 11, 2009
United States |

US FDA may get large increase in funding

Today the Wall Street Journal published an article noting that President Obama has requested an additional $300,000,000 in funding for the US FDA, from $2.06 billion to $2.35 billion. That's a 14% increase.  If the funding is approved by Congress, the agency will likely hire more inspectors which will lead to more frequent visits from the FDA to medical device manufacturers.

The WSJ article quotes: "The FDA's budget has shrunk or been held flat since the mid 1990s. Mr. Hubbard (with the FDA) said this increase, along with an increase of about $172 million from the...

Source | Emergo Marketing
May 8, 2009
United States |

US FDA announces new website

The Food and Drug Administration has said that it plans to launch a redesigned website, presumably in 2009. This should be good news for users of the site. Hopefully, guidance documents and other relevant information will be easier to find, and databases will be easier to use.  Keep your fingers crossed.

Source | Emergo Marketing
May 1, 2009
United States |

US FDA issues notice on preamendment Class III devices

The Food and Drug Administration (FDA) just posted a notice in the April 9, 2009 Federal Register notifying manufacturers of 25 types of Class III medical devices that their products will be subject t

Source | Emergo Marketing
Apr 9, 2009