Tag Archives: vigilance

MHRA Publishes Draft Guidance on Vigilance Systems for Joint Replacement Implants

Posted on October 2, 2010 by admin| Leave a comment

MHRA Publishes Draft Guidance on Vigilance Systems for Joint Replacement Implants

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This guidance document gives advice to manufacturers on the notification of adverse incidents involving joint replacement implants under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC and Directive 2005/05/EC. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System and the Medicines and Healthcare products Regulatory Agency’s Directives Bulletin  ‘Guidance on the operation of the EU vigilance system in the UK’. This guidance sets out the Medicines and Healthcare products Regulatory Agency’s (MHRA) views on the interpretation of the Medical Devices Regulations. It should not be considered to be an authoritative statement of the law in any particular case as it is intended as guidance only. Manufacturers and others should consult the legislation referred to, making their own decisions on matters affecting them in conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions, misleading or other statements in the guidance whether negligent or otherwise. An authoritative statement could be given only by the courts.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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MHRA, the UK Regulators, Publish Guidance on the Vigilance System for CE-Marked Medical Devices, Cardiac Ablation Catherters

Posted on July 19, 2010 by admin| Leave a comment

MHRA, the UK Regulators, Publish Guidance on the Vigilance System for CE-Marked Medical Devices, Cardiac Ablation Catheters

Full Text Here

This guidance document gives advice to manufacturers on the notification of adverse incidents involving cardiac ablation catheters (CACs) under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC as amended by 2007/47/EC. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System, and MHRA’s Directives Bulletin 3, Guidance on the operation of the EU vigilance system in the UK.
This guidance sets out the Medicines and Healthcare products Regulatory Agency’s (MHRA) views on the interpretation of the Medical Devices Regulations. It should not be considered to be an authoritative statement of the law in any particular case as it is intended as guidance only. Manufacturers and others should consult the legislation referred to, making their own decisions on matters affecting them in conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions, misleading or other statements in the guidance whether negligent or otherwise. An authoritative statement could be given only by the courts.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Device Regulators, MHRA, Publish Draft for Comment on Vigilance Systems for CE-Marked Medical Devices – Cardiac Ablation Catheters

Posted on March 6, 2010 by admin| Leave a comment

Device Regulators, MHRA, Publish Draft for Comment on Vigilance Systems for CE-Marked Medical Devices – Cardiac Ablation Catheters.

Full Text Here

This guidance document gives advice to manufacturers on the notification of adverse incidents involving cardiac ablation catheters (CACs) under the Medical Devices
Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC and amended by 2007/47/EC. It is
supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System, and MHRA Directives Bulletin 3
- Guidance on the operation of the EU vigilance system in the UK . This guidance sets out the Medicines and Healthcare products Regulatory Agency’s
(MHRA) views on the interpretation of the Medical Devices Regulations. It should not be considered to be an authoritative statement of the law in any particular case as it is
intended as guidance only. Manufacturers and others should consult the legislation referred to, making their own decisions on matters affecting them in conjunction with
their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions, misleading or other statements in the guidance whether
negligent or otherwise. An authoritative statement could be given only by the courts.

Development Consultancy

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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ida consultants freestrategyconsultation 515x64 Device Regulators, MHRA, Publish Draft for Comment on Vigilance Systems for CE Marked Medical Devices Cardiac Ablation Catheters

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Medical Device Regulators Publish Guidance on Vigilance Systems Breast Implants

Posted on November 19, 2009 by admin| Leave a comment

Medical Device Regulators Publish Guidance on Vigilance Systems Breast Implants

Full Text Here

This guidance document gives advice to manufacturers on the notification of adverse incidents involving breast implants under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System, and the MHRA’s Directives Bulletin 3 ‘Guidance on the operation of the EU vigilance system in the UK’.
This guidance sets out the Medicines and Healthcare products Regulatory Agency’s (MHRA) views on the interpretation of the Medical Devices Regulations. It should not be considered to be an authoritative statement of the law in any particular case as it is intended as guidance only. Manufacturers and others should consult the legislation referred to, making their own decisions on matters affecting them in conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions, misleading or other statements in the guidance whether negligent or otherwise. An authoritative statement could be given only by the courts.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

ida 100programme 515x64 LowRes Medical Device Regulators Publish Guidance on Vigilance Systems Breast Implants

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ida consultants freestrategyconsultation 515x64 Medical Device Regulators Publish Guidance on Vigilance Systems Breast Implants

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Device Regulators Publish Guidance on Vigilance System for CE marked Breast Implants

Posted on October 12, 2009 by admin| Leave a comment

Device Regulators, MHRA, Publish Draft Guidance on Vigilance Systems for CE marked Breast Implants

This guidance document gives advice to manufacturers on the notification of adverse incidents involving breast implants under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC . It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System, and the MHRA’s Directives Bulletin 3 ‘Guidance on the operation of the EU vigilance system in the UK’.

Full Guidance Here.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

ida 100programme 515x64 LowRes Device Regulators Publish Guidance on Vigilance System for CE marked Breast Implants

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As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Device Regulators Publish Guidance on Vigilance System for CE marked Breast Implants

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Draft Guidance Published by Drug Regulators on CE-marked Medical Devices – Neurostimulators

Posted on August 24, 2009 by admin| Leave a comment

Drug Regulators, MHRA, Publish Draft Guidance on the Vigilance System for CE-marked devices – Neurostimulators.

A full copy is available here.

Introduction

This guidance sets out the Medicines and Healthcare products Regulatory Agency’s (MHRA) views on the interpretation of the Medical Devices Regulations.

Why Report

To obtain information on device related incidents, the Medical Devices Directive requires manufacturers to have procedures in place for systematic review of experience gained from device usage in the post-production phase.

What Should Be Reported

The Medical Devices Directive, through the relevant national regulations [4], requires manufacturers to notify the relevant competent authority (the MHRA in the UK) if:

  • They know of any deterioration or malfunction of a neurostimulator, or any inadequacy in the instructions for use which has led, or might lead, to a serious deterioration in the state of health.
  • The neurostimulator has been subject to a Field Safety Corrective Action

Periodic Summary Reporting

Some adverse incidents are appropriate for periodic summary reporting:

  • lead fracture
  • lead shorts
  • lead migration
  • high lead impedance
  • electromagnetic interference

Adverse event trending

Some adverse incidents are expected and foreseeable, and as a result may be considered not routinely reportable. These must all be clearly identified in the manufacturer’s labelling, clinically well recognised and quantifiably predictable, well documented in the device master record with an appropriate risk assessment, and clinically acceptable in terms of individual patient benefit.

    If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

    Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

    ida 100programme 515x64 LowRes Draft Guidance Published by Drug Regulators on CE marked Medical Devices Neurostimulators

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    As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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    This guideline ap
    recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
    ida consultants freestrategyconsultation 515x64 Draft Guidance Published by Drug Regulators on CE marked Medical Devices Neurostimulators

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