is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, April 18th, 2012. For more details, or to register please visit our site at www.fxconferences.com
An investigator's brochure (IB) is required for compliance with the EU Medical Device Directives (e.g. 2.7.2) and also with ISO 14155: Clinical Investigations of Medical Devices in Human Subjects – Good Clinical Practices. The development of an IB for medical devices should reflect the engineering features of the device, in much the same way that an IB for pharmaceutical agents reflects the chemical features of the drug. As a dynamic document, the IB must be carefully constructed and, ideally, it should accurately represent the current state of all knowledge about the investigational product – including information about AEs, SAEs, and important manufacturing details as well as nonclinical and clinical study results.
This audio conference presentation provides an overview and best practices for the medical device IB, looking at some of the related issues specific to devices and discussing how the brochure is likely to evolve over time.
Showing posts with label EU. Show all posts
Showing posts with label EU. Show all posts
Monday, April 9, 2012
Friday, March 23, 2012
eLabeling Medical Devices for the EU Market
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.
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, March 12, 2012
The Revised RoHS Directive and What It Means for Device Manufacturers
is being presented by Dr. Joachim Wilke, Director, Regulatory Affairs & Policy, Europe, with Medtronic and airs on Thursday, March 15th, 2012. For more details or to register, please visit our site at www.fxconferences.com
In July 2011 the EU Commission published the recast Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU which will replace the original RoHS Directive 2002/95/EC. The new Directive has to be transposed into the national laws of EU Member States by January 2, 2013. In contrast to the original version, its scope will include Medical Devices effective July 22, 2014, and therefore RoHS compliance will become one of the major quality and regulatory activities of medical device manufacturers during the upcoming months.
This audio conference presentation summarizes the requirements of Directive 2011/65/EU with particular attention to its scope and exemptions. Our speaker also explains the responsibilities of manufacturers and distributors. According to the Directive, RoHS compliance must be demonstrated by a Declaration of Conformity and by affixing a CE mark to the device. As a matter of fact, the Medical Device Directive 93/42/EEC CE mark, which includes the Notified Body identification number, will cover RoHS compliance in the future as well. Accordingly, this presentation covers questions related to Notified Body Quality Management auditing including Technical File and Declaration of Conformity review.
In July 2011 the EU Commission published the recast Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU which will replace the original RoHS Directive 2002/95/EC. The new Directive has to be transposed into the national laws of EU Member States by January 2, 2013. In contrast to the original version, its scope will include Medical Devices effective July 22, 2014, and therefore RoHS compliance will become one of the major quality and regulatory activities of medical device manufacturers during the upcoming months.
This audio conference presentation summarizes the requirements of Directive 2011/65/EU with particular attention to its scope and exemptions. Our speaker also explains the responsibilities of manufacturers and distributors. According to the Directive, RoHS compliance must be demonstrated by a Declaration of Conformity and by affixing a CE mark to the device. As a matter of fact, the Medical Device Directive 93/42/EEC CE mark, which includes the Notified Body identification number, will cover RoHS compliance in the future as well. Accordingly, this presentation covers questions related to Notified Body Quality Management auditing including Technical File and Declaration of Conformity review.
Wednesday, December 7, 2011
eLabeling Medical Devices for the EU Market
is being presented by Salma Michor, CEO and Principal Consultant, with Michor Consulting EU and airs on Tuesday, January 10th, 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.
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, December 5, 2011
Opportunities in the European Regulatory Framework for Orphan Medicinal Products
is being presented by Dr. Maureen Graham, Managing Director, of Diamond BioPharm Limited and airs on Wednesday, January 11th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The orphan drug regulation in Europe came into force over 10 years ago, with the aim of stimulating research and development of medicinal products for rare diseases. Obtaining and maintaining orphan status opens up a number of opportunities to companies developing such products, but it is crucial to have a thorough understanding of the orphan rules in Europe in order to fully benefit from the incentives offered.
This audio conference presentation provides an overview of the legislative framework, and highlights the incentives available. Our speaker focuses on the most important aspects that need to be considered when compiling an application for orphan designation, and how this may impact the development program. Finally, the presentation summarizes both the potential pros and cons will be summarized.
The orphan drug regulation in Europe came into force over 10 years ago, with the aim of stimulating research and development of medicinal products for rare diseases. Obtaining and maintaining orphan status opens up a number of opportunities to companies developing such products, but it is crucial to have a thorough understanding of the orphan rules in Europe in order to fully benefit from the incentives offered.
This audio conference presentation provides an overview of the legislative framework, and highlights the incentives available. Our speaker focuses on the most important aspects that need to be considered when compiling an application for orphan designation, and how this may impact the development program. Finally, the presentation summarizes both the potential pros and cons will be summarized.
Tuesday, November 1, 2011
Conducting Clinical Evaluations to Support Regulatory Approval and Marketing of Medical Devices
is being presented by Janette Benaddi, CEO, of Medvance and airs on Wednesday, November 16th, 2011. For more details, or to register please visit our site at www.fxconferences.com
With the recent amendments to the EU medical devices directive (MDD), there is much more emphasis being placed on the clinical evaluation process, and how this should be appropriately conducted. Indeed, in Europe it is now mandatory to conduct a clinical evaluation for some classes of medical device. In this presentation, our speaker reviews everything you need to know to be able to conduct a systematic literature review/clinical evaluation for your products, and prepare a report that will satisfy your Notified Body.
This audio conference is designed specifically for those involved in gathering clinical evidence and conducting clinical evaluations to support the regulatory approval and marketing of medical devices. It should be of particular interest to those involved in collating clinical evidence, including regulatory and clinical staff conducting literature reviews/clinical evaluations. It will also be of use to staff working in quality departments and research and development departments.
With the recent amendments to the EU medical devices directive (MDD), there is much more emphasis being placed on the clinical evaluation process, and how this should be appropriately conducted. Indeed, in Europe it is now mandatory to conduct a clinical evaluation for some classes of medical device. In this presentation, our speaker reviews everything you need to know to be able to conduct a systematic literature review/clinical evaluation for your products, and prepare a report that will satisfy your Notified Body.
This audio conference is designed specifically for those involved in gathering clinical evidence and conducting clinical evaluations to support the regulatory approval and marketing of medical devices. It should be of particular interest to those involved in collating clinical evidence, including regulatory and clinical staff conducting literature reviews/clinical evaluations. It will also be of use to staff working in quality departments and research and development departments.
Tuesday, October 18, 2011
Technical Documentation Requirements for Device Approval in the EU
is being presented by Tamas Borsai, Division Manager, MHS - Customer Service and Quality, with TUV SUD America Inc. and airs on Thursday, November 10th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Wednesday, October 12, 2011
Industry Update – European Human Tissues Regulation
is being presented by Richard van der Linden, Senior Consultant, with Signifix and airs on Tuesday, November 8th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Since the gradual implementation of the Human Tissues and Cells Directive 2004/23/EC (EUTCD) in the European Union, industry and hospitals now know the minimal safety and quality requirements for products made from human tissues and cells. The EUTCD’s transposition defines a framework defining Tissue Establishments (TE) – which can be profit or non-profit organizations – as centers via which the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells is regulated. Within the Tissue Establishment, the Responsible Person (RP) is responsible for safeguarding the safety and quality of the human tissues and cells.
In addition, a number of EU member states have put in place their own country-specific requirements on donor tissues and cells, which sometimes runs contrary to “free movement of tissues and cells” between member states, and puts constraints on acceptability of tissue and cell donors and the routes via which a tissue or cell product can cross borders.
This audio conference addresses the implications of transposition of the EUTCD in the different member states, reviews the definitions of TE and RP, and provides an update for attendees on the extra country-specific requirements added by individual member states.
Since the gradual implementation of the Human Tissues and Cells Directive 2004/23/EC (EUTCD) in the European Union, industry and hospitals now know the minimal safety and quality requirements for products made from human tissues and cells. The EUTCD’s transposition defines a framework defining Tissue Establishments (TE) – which can be profit or non-profit organizations – as centers via which the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells is regulated. Within the Tissue Establishment, the Responsible Person (RP) is responsible for safeguarding the safety and quality of the human tissues and cells.
In addition, a number of EU member states have put in place their own country-specific requirements on donor tissues and cells, which sometimes runs contrary to “free movement of tissues and cells” between member states, and puts constraints on acceptability of tissue and cell donors and the routes via which a tissue or cell product can cross borders.
This audio conference addresses the implications of transposition of the EUTCD in the different member states, reviews the definitions of TE and RP, and provides an update for attendees on the extra country-specific requirements added by individual member states.
Tuesday, September 13, 2011
EU Regulatory Requirements for Medical Devices Utilizing Tissues of Animal Origin
is being presented by Steve Coppock, MHS Auditor, with TÜV SÜD America, Inc and airs on Tuesday, October 11th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The medical device industry has a long and successful history in the use of tissues of animal origin in the design and manufacture of medical devices. However, with the first appearance in the mid 1990s of a variant form of Creutzfeldt-Jakob Disease (vCJD), a fatal brain disease of humans, as a result of the bovine spongiform encephalopathy (BSE or “mad-cow” disease) epidemic in the UK, regulatory requirements were enacted in the European Community aimed at minimizing the inherent risks associated with the safe use of such devices. This audio conference presentation discusses the risks inherent in devices using tissues of animal origin, and reviews the various European regulatory requirements and guidance documents applicable to such medical devices.
The medical device industry has a long and successful history in the use of tissues of animal origin in the design and manufacture of medical devices. However, with the first appearance in the mid 1990s of a variant form of Creutzfeldt-Jakob Disease (vCJD), a fatal brain disease of humans, as a result of the bovine spongiform encephalopathy (BSE or “mad-cow” disease) epidemic in the UK, regulatory requirements were enacted in the European Community aimed at minimizing the inherent risks associated with the safe use of such devices. This audio conference presentation discusses the risks inherent in devices using tissues of animal origin, and reviews the various European regulatory requirements and guidance documents applicable to such medical devices.
Monday, September 12, 2011
Complying with EU Requirements for Medical Device Software
is being presented by Poul Schmidt-Andersen, Managing Partner, with Danish Medical Devices Consulting and airs on Thursday, September 29th, 2011. For more details, or to register please visit our site at www.fxconferences.com
This audio conference presentation highlights the new European Union requirements for software systems arising from the latest amendments to the Medical Devices Directive (MDD). The presentation focuses on how software should be designed to ensure the repeatability, reliability and performance of systems according to the intended use. Our speaker also addresses how, in the event of a single fault condition in the system, appropriate means can be adopted and documented to show that risk has been eliminated or reduced as far as possible. The presentation also covers how to establish suitable documentation to demonstrate compliance and satisfy Notified Body reviewers.
This audio conference presentation highlights the new European Union requirements for software systems arising from the latest amendments to the Medical Devices Directive (MDD). The presentation focuses on how software should be designed to ensure the repeatability, reliability and performance of systems according to the intended use. Our speaker also addresses how, in the event of a single fault condition in the system, appropriate means can be adopted and documented to show that risk has been eliminated or reduced as far as possible. The presentation also covers how to establish suitable documentation to demonstrate compliance and satisfy Notified Body reviewers.
Tuesday, August 30, 2011
Clinical Evaluation of Medical Devices in the EU
is being presented by Anthony L. Fitzhugh, M.D., Project Manager/Lead Auditor, with TUV SUD America Inc. and airs on Thursday, September 29th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Annex X of the Medical Device Directive (EC Directive 93/42/EEC) requires that a manufacturer who seeks to place a medical device on the market in the EU first conduct and document in the technical file/design dossier a clinical evaluation that fully evaluates the safety and efficacy of the device. An amendment (2007/47/EEC) to the Medical Device Directive—published in 2007— has made this requirement even more stringent than in the recent past. The clinical evaluation must now be documented in such a manner that this section of the file comprises a standalone document. Moreover, all manufacturers must actively maintain their compliance with the aforementioned clinical requirements as well as post-market clinical follow-up—unless it can be shown to be not necessary.
As a result of these changes, those working in regulatory affairs must ensure that they have the proper expertise and strategy in place to allow their company to comply with these requirements prior to and after placement of their medical device on the EU market. This audio conference presentation covers the EU regulatory framework for meeting the revised clinical requirements, as well as strategies for maintaining the clinical data section of the technical file or design dossier.
Annex X of the Medical Device Directive (EC Directive 93/42/EEC) requires that a manufacturer who seeks to place a medical device on the market in the EU first conduct and document in the technical file/design dossier a clinical evaluation that fully evaluates the safety and efficacy of the device. An amendment (2007/47/EEC) to the Medical Device Directive—published in 2007— has made this requirement even more stringent than in the recent past. The clinical evaluation must now be documented in such a manner that this section of the file comprises a standalone document. Moreover, all manufacturers must actively maintain their compliance with the aforementioned clinical requirements as well as post-market clinical follow-up—unless it can be shown to be not necessary.
As a result of these changes, those working in regulatory affairs must ensure that they have the proper expertise and strategy in place to allow their company to comply with these requirements prior to and after placement of their medical device on the EU market. This audio conference presentation covers the EU regulatory framework for meeting the revised clinical requirements, as well as strategies for maintaining the clinical data section of the technical file or design dossier.
Thursday, August 18, 2011
In-Vitro Diagnostics: Testing Times
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Thursday, September 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The regulations relating to the testing of new in-vitro diagnostic tests are not always clear. There are various regulations that require compliance: the In-Vitro Diagnostics Directive in the EU, ISO standards, and the US regulations. There is the added complexity of CLIA waivers in the US for those IVDs designed to be used outside the laboratory setting.
In this audio conference, the speaker will describe and review the regulations that govern the testing and approval of new in-vitro diagnostics in the EU and USA. Performance testing and CLIA waiver studies will be included. The aim is to clarify the requirements and assist in the design of any clinical testing that may be required.
The regulations relating to the testing of new in-vitro diagnostic tests are not always clear. There are various regulations that require compliance: the In-Vitro Diagnostics Directive in the EU, ISO standards, and the US regulations. There is the added complexity of CLIA waivers in the US for those IVDs designed to be used outside the laboratory setting.
In this audio conference, the speaker will describe and review the regulations that govern the testing and approval of new in-vitro diagnostics in the EU and USA. Performance testing and CLIA waiver studies will be included. The aim is to clarify the requirements and assist in the design of any clinical testing that may be required.
Tuesday, August 9, 2011
Best Practices for Managing In-Country Translation Reviews
is being presented by Andres Heuberger, President, of ForeignExchange Translations, Inc. and airs on Wednesday, August 31st, 2011. For more details on this event or to register, please visit our site at www.fxconferences.com
It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
With proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches. This presentation shows you how.
It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
With proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches. This presentation shows you how.
Tuesday, July 5, 2011
Technical Documentation Requirements for Device Approval in the EU
is being presented by Tamas Borsai, Division Manager, MHS - Customer Service and Quality, with TUV SUD America Inc. and airs on Tuesday, August 9th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Wednesday, June 1, 2011
Complying with FCPA and Related Anti-Corruption Measures
is being presented by David F. Axelrod, Managing Member, with Axelrod Laliberte LLP and airs on Wednesday, June 22nd, 2011. For more details, or to register please visit our site at www.fxconferences.com
For the first 20 years of its existence, the Foreign Corrupt Practices Act (FCPA) was rarely used, and EU countries had nothing comparable. More recently, however, the FCPA has been aggressively enforced against individuals, as well as U.S. and foreign companies. Fines have been imposed at unprecedented levels and individuals (including a former U.S. Congressman) jailed. EU governments have also gotten serious about fighting corruption, starting with the 1998 OECD convention against bribery and culminating, so far, with the UK anti-bribery statute.
This audio conference presentation looks at the history, scope and elements of the FCPA, anti-corruption compliance programs, red flags, investigations, and U.S. government expectations for pre-transaction due diligence. It also covers defenses and policy considerations concerning a key exception to liability, facilitating payments. Our speaker also discusses the UK anti-bribery statute and its key differences from the FCPA. Finally, the presentation looks at the relevance of the statute to smaller companies that may have only a limited overseas presence.
For the first 20 years of its existence, the Foreign Corrupt Practices Act (FCPA) was rarely used, and EU countries had nothing comparable. More recently, however, the FCPA has been aggressively enforced against individuals, as well as U.S. and foreign companies. Fines have been imposed at unprecedented levels and individuals (including a former U.S. Congressman) jailed. EU governments have also gotten serious about fighting corruption, starting with the 1998 OECD convention against bribery and culminating, so far, with the UK anti-bribery statute.
This audio conference presentation looks at the history, scope and elements of the FCPA, anti-corruption compliance programs, red flags, investigations, and U.S. government expectations for pre-transaction due diligence. It also covers defenses and policy considerations concerning a key exception to liability, facilitating payments. Our speaker also discusses the UK anti-bribery statute and its key differences from the FCPA. Finally, the presentation looks at the relevance of the statute to smaller companies that may have only a limited overseas presence.
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.
Wednesday, April 13, 2011
The New Rules for Safety and Performance of Medical Devices in the EU
is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Thursday, May 19th, 2011. For more details, or to register please visit our site at www.fxconferences.com
In the EU rules relating to the safety and performance of medical devices were harmonized in the 1990s. The legal framework consists of three main directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.
The revised MDD 93/42/EC (via 2007/47/EC) took effect in March 2010, marking the onset of more rigorous regulations in the EU. Manufacturers must comply with the new requirements for both new products and products already on the market. This audio conference provides an overview of the latest updates introduced by Directive 2007/47/EC, and what they mean for device manufacturers.
In the EU rules relating to the safety and performance of medical devices were harmonized in the 1990s. The legal framework consists of three main directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.
The revised MDD 93/42/EC (via 2007/47/EC) took effect in March 2010, marking the onset of more rigorous regulations in the EU. Manufacturers must comply with the new requirements for both new products and products already on the market. This audio conference provides an overview of the latest updates introduced by Directive 2007/47/EC, and what they mean for device manufacturers.
Monday, March 21, 2011
Understanding and Implementing the New EU Annex 11
is being presented by Dr. Ludwig Huber, Director, with LabCompliance and airs on Tuesday, April 26th, 2011. For more details, or to register please visit our site at www.fxconferences.com
After more than 15 years the EU has released a new final version of Annex 11. Together with the updated EU Chapter 4 on documentation, it forms the EU equivalent to FDA's Part 11. Compared to the older version, it has more details and some very specific requirements. It addresses the regulatory needs of modern IT equipment, and when implemented correctly, it also has business benefits through reduced failure rates. The document is a good framework for validation and use of computer systems and handling electronic records in different regulated environments.
This audio conference presentation provides attendees with an overview and a good understanding of the Annex 11 requirements, and also provides recommendations and tools for cost-effective implementation.
After more than 15 years the EU has released a new final version of Annex 11. Together with the updated EU Chapter 4 on documentation, it forms the EU equivalent to FDA's Part 11. Compared to the older version, it has more details and some very specific requirements. It addresses the regulatory needs of modern IT equipment, and when implemented correctly, it also has business benefits through reduced failure rates. The document is a good framework for validation and use of computer systems and handling electronic records in different regulated environments.
This audio conference presentation provides attendees with an overview and a good understanding of the Annex 11 requirements, and also provides recommendations and tools for cost-effective implementation.
Tuesday, February 8, 2011
Safety Reporting for Clinical Trials
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, March 9th, 2011. For more details or to register, please visit our site at www.fxconferences.com
This audio conference provides an overview of the rules for expedited and periodic safety reporting for clinical trials of drugs and medical devices in the EU and USA. It is relatively easy to be compliant in the harmonized world of pharmaceutical clinical trials. However, this contrasts with the disparate requirements for medical device studies.
In this presentation, our speaker reviews the regulations and guidance and explains what needs to be reported to the regulatory authority and ethics committee or IRB, and when. The presentation also explains the procedures that need to be in place to ensure compliance for safety reporting in complex situations such as trials that span different regions, or trials of products that are regulated differently in different territories. Other "hot button" topics are addressed as well. Attendees learn what needs to be reported when, and how to set up procedures that ensure compliance with safety reporting requirements, whether the clinical trial is a simple one or more complicated.
This audio conference provides an overview of the rules for expedited and periodic safety reporting for clinical trials of drugs and medical devices in the EU and USA. It is relatively easy to be compliant in the harmonized world of pharmaceutical clinical trials. However, this contrasts with the disparate requirements for medical device studies.
In this presentation, our speaker reviews the regulations and guidance and explains what needs to be reported to the regulatory authority and ethics committee or IRB, and when. The presentation also explains the procedures that need to be in place to ensure compliance for safety reporting in complex situations such as trials that span different regions, or trials of products that are regulated differently in different territories. Other "hot button" topics are addressed as well. Attendees learn what needs to be reported when, and how to set up procedures that ensure compliance with safety reporting requirements, whether the clinical trial is a simple one or more complicated.
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.
Subscribe to:
Posts (Atom)