is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Wednesday, March 28th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Showing posts with label Directive 93/42/EEC. Show all posts
Showing posts with label Directive 93/42/EEC. Show all posts
Friday, March 23, 2012
Monday, May 2, 2011
EU Medical Device Classification - Overview and Update
is being presented by Mika Reinikainen, Managing Director, with Abnovo Ltd. and airs on Tuesday, May 10th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Medical device companies wishing to market their products in the European Union must first determine the classification of their devices in accordance with rules set out in Annex IX of Council Directive 93/42/EEC. Device classification is based on the level of risk, from Class I (low risk) to Class III (high risk), and while manufacturers can self-certify certain low-risk devices, those posing a higher risk to users must have their classification verified by a Notified Body. This tiered system can lead to confusion, as device companies attempt to classify a wide variety of products.
This audio conference provides a detailed overview of the EU medical device classification system, and provides an update on the latest developments. The presentation reviews the various classes and categories, exploring the reasons and basic concepts behind them, and what they mean in terms of compliance. Using practical examples from industry, our speaker also discusses the emerging issue of classifying medical device software, as well as special devices and reclassification.
Medical device companies wishing to market their products in the European Union must first determine the classification of their devices in accordance with rules set out in Annex IX of Council Directive 93/42/EEC. Device classification is based on the level of risk, from Class I (low risk) to Class III (high risk), and while manufacturers can self-certify certain low-risk devices, those posing a higher risk to users must have their classification verified by a Notified Body. This tiered system can lead to confusion, as device companies attempt to classify a wide variety of products.
This audio conference provides a detailed overview of the EU medical device classification system, and provides an update on the latest developments. The presentation reviews the various classes and categories, exploring the reasons and basic concepts behind them, and what they mean in terms of compliance. Using practical examples from industry, our speaker also discusses the emerging issue of classifying medical device software, as well as special devices and reclassification.
Thursday, January 20, 2011
eLabeling Medical Devices for the EU Market: Issues and Advantages
is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Wednesday, February 16th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Monday, January 4, 2010
Are You Ready for MDD Amendment Directive 2007/47/EC?
Time is running out – ease your MDD compliance strategy stress with detailed guidance from a leading expert!
The revised MDD 93/42/EEC comes into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future. There is no transition date for the amendment 2007/47/EC and if you are not in line with these new requirements by the implementation date, you could lose your CE mark certificate from your notified body.
In this audio conference, our speaker provides an overview of the changes to the MDD, including: changes to definitions, the essential requirements, technical documentation requirements, classification rules, labeling requirements, and new requirements for usability (user error) and clinical data. The presentation also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment.
Are You Ready for MDD Amendment Directive 2007/47/EC? is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Wednesday, January 27, 2010. For more details or to register, please visit our site at www.fxconferences.com
The revised MDD 93/42/EEC comes into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future. There is no transition date for the amendment 2007/47/EC and if you are not in line with these new requirements by the implementation date, you could lose your CE mark certificate from your notified body.
In this audio conference, our speaker provides an overview of the changes to the MDD, including: changes to definitions, the essential requirements, technical documentation requirements, classification rules, labeling requirements, and new requirements for usability (user error) and clinical data. The presentation also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment.
Are You Ready for MDD Amendment Directive 2007/47/EC? is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Wednesday, January 27, 2010. For more details or to register, please visit our site at www.fxconferences.com
Thursday, December 17, 2009
EU Medical Device eLabeling, Compliance & Software Requirements
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. Currently, most Instructions for Use are provided in paper format, which can be very lengthy. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.
However, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.
EU Medical Device eLabeling, Compliance & Software Requirements is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Wednesday, January 13, 2010. For more details or to register, please visit our site at www.fxconferences.com
However, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.
EU Medical Device eLabeling, Compliance & Software Requirements is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Wednesday, January 13, 2010. For more details or to register, please visit our site at www.fxconferences.com
Friday, November 13, 2009
Friday special - save 75% on "Device e-Labeling & Regulatory Compliance in the EU"
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. Currently, most Instructions for Use are provided in paper format, which can be very lengthy.
The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.
However, the latest revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.
But hurry! If you purchase Device e-Labeling & Regulatory Compliance in the EU" by November 19, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.
The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.
However, the latest revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.
But hurry! If you purchase Device e-Labeling & Regulatory Compliance in the EU" by November 19, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.
Thursday, April 30, 2009
Device e-Labeling & Regulatory Compliance in the EU
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. Currently, most Instructions for Use are provided in paper format, which can be very lengthy. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.
However, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.
Device e-Labeling & Regulatory Compliance in the EU is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, June 18, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com
However, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.
Device e-Labeling & Regulatory Compliance in the EU is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, June 18, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com
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