Medical devices industry 5 Forces

Partnership

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT on medical devices

TABLE OF CONTENTS

1. Summary

2. Introduction

3. Medical devices - an area of ​​growing

4. Legal framework

5. Reporting under Article 11, paragraph 4 of Directive 93/42/EC

5.1. Vigilance

5.2. Clinical investigations

5.3. Pharmaceutical consultations

6. Need to improve the overall implementation guidelines

6.1. Conformity assessment

6.1.1. Obligations under of conformity assessment procedures.

6.1.2. Reclassification of medical devices

6.1.3. Improvements for the designation and monitoring of Notified Bodies

6.2. Transparency and trust

6.3. Market surveillance

6.4. Cooperation between the Commission and the Member States

7. Enlargement and the international dimension

7.1. Enlargement

7.2. Mutual Recognition Agreements

7.3. The "Global Harmonization Task Force"

8. Conclusions

Appendix 1 - Summary of information - article 11 section 4 of 93/42/EC - Vigilance

Appendix 2 - Summary of information - article 11 section 4 of 93/42/EC - Clinical Investigations

Appendix 3 - Summary of information - article 11 section 4 of 93/42/EC - Pharmaceutical consultations

Appendix 4 - Programme of work of the working groups and task forces

Annex 5 - Main areas of regulatory changes seem necessary

Appendix 6 - Other Measures

Appendix 1 - Coverage of medical devices

Appendix 2 - The benefits of medical technology and medical devices for EU citizens

Appendix 3 - Main features of regulatory framework

Appendix 4 - Working groups involved in the implementation of directives on medical devices

1. Summary

This Communication sets out the strategic findings of the Commission with regard to the functioning of Directives on medical devices. Elles sont basées sur les questions mises en lumière dans le rapport du groupe d'experts "Dispositifs médicaux" (MDEG) qui a été publié sur le site "Europa" de la Commission en juin 2002 [1].

[1] medical_devices/index.htm

Cette communication répond en premier lieu aux exigences de la directive 93/42/CEE relative aux dispositifs médicaux qui prévoient que la Commission soumet au Conseil un rapport sur la mise en oeuvre des dispositions de la directive concernant la vigilance, les investigations cliniques et la consultation des autorités compétentes en matière de produits pharmaceutiques. Les données transmises par les États membres sur ces questions se sont révélées relativement hétérogènes et il est difficile de tirer des conclusions définitives. La Commission propose donc d'intensifier les efforts en vue de compléter la collecte de données. Dans la mesure où il a été reconnu nécessaire d'adopter une approche plus coordonnée entre les États membres, la communication annonce l'élaboration de nouveaux documents d'orientation.

CreateSpace Independent Publishing Platform Principles of Design controls for Medical Device: A handbook for Professionals in the Medical Device Industry (Volume 1)
Book (CreateSpace Independent Publishing Platform)
2013-06-22 08:11:39 by flaveur

Al Franken: "Obamacare" is a "job killer."

The Senate voted 79 to 20 to repeal Obamacare's medical device tax Thursday evening in a bipartisan budget amendment.
"I want to repeal the medical device tax altogether. But I am concerned that we are running out of time before this job-killing tax goes into effect. So, for now, the best thing to do to ensure that this important industry continues to create jobs and producing life-saving devices is to delay this unwise tax," said Sen

2013-06-04 19:13:13 by flaveur

79-20 Senate voted to repeal "Obamacare" funding

The Senate voted 79 to 20 to repeal Obamacare's medical device tax Thursday evening in a bipartisan budget amendment.
"I want to repeal the medical device tax altogether. But I am concerned that we are running out of time before this job-killing tax goes into effect. So, for now, the best thing to do to ensure that this important industry continues to create jobs and producing life-saving devices is to delay this unwise tax," said Sen

2013-05-16 14:17:48 by flaveur

79-20, Senate voted to defund "Obamacare."

The Senate voted 79 to 20 to repeal Obamacare's medical device tax Thursday evening in a bipartisan budget amendment in a nonbinding resolution.
"I want to repeal the medical device tax altogether. But I am concerned that we are running out of time before this job-killing tax goes into effect. So, for now, the best thing to do to ensure that this important industry continues to create jobs and producing life-saving devices is to delay this unwise tax," said Sen

2013-05-19 18:50:08 by flaveur

79-20 ...... ouch

The Senate voted 79 to 20 to repeal Obamacare's medical device tax Thursday evening in a bipartisan budget amendment.
"I want to repeal the medical device tax altogether. But I am concerned that we are running out of time before this job-killing tax goes into effect. So, for now, the best thing to do to ensure that this important industry continues to create jobs and producing life-saving devices is to delay this unwise tax," said Sen

2013-05-19 18:49:34 by flaveur

79-20

The Senate voted 79 to 20 to repeal Obamacare's medical device tax Thursday evening in a bipartisan budget amendment.
"I want to repeal the medical device tax altogether. But I am concerned that we are running out of time before this job-killing tax goes into effect. So, for now, the best thing to do to ensure that this important industry continues to create jobs and producing life-saving devices is to delay this unwise tax," said Sen

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