MEDICAL DEVICES: Guidance document - …

- 1 - EUROPEAN COMMISSION DG ENTERPRISE Directorate G Unit 4 - Pressure Equipment, Medical Devices, Metrology MEDICAL DEVICES: Guidance document MEDDEV 2.4/1 Rev.8

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of Notified Bodies Medical Devices (NB-MED) on …

Co-ordination of Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC Table of contents Issue Page

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Title: Post-Marketing Surveillance (PMS) post …

Co-ordination of Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC Rationale and history sheet

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MEDICAL DEVICES Guidance document …

4 1. PURPOSE AND PHILOSOPHY OF MEDICAL DEVICE CLASSIFICATION It is not feasible economically nor justifiable in practice to subject all medical devices to the most rigorous conformity assessment procedures available.

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MANUAL ON BORDERLINE AND CLASSIFICATION …

1 manual on borderline and classification in the community regulatory framework for medical devices version 1.12 (04-2012) please note: the views expressed in this manual are not legally

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MANUAL ON BORDERLINE AND CLASSIFICATION …

1 manual on borderline and classification in the community regulatory framework for medical devices version 1.11 (12-2011) please note: the views expressed in this manual are not legally

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GUIDELINES ON MEDICAL DEVICES - Productos …

Page 4 of 6 4. REPORTABLE EVENTS UNDER ANNEX 7 AND ANNEX X OF DIRECTIVES 90/385/EEC AND 93/42/EEC RESPECTIVELY. For the purpose of this guidance and based on the definitions above, the following events

MEDICAL DEVICES Guidance document - …

5 ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic

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GUIDELINES ON MEDICAL DEVICES IVD GUIDANCE …

Page 5 of 4 (b) So called ‘research use’ products being tested against a comparator IVD product that bears the CE mark: In this case the fact that the so-called ‘research use’ product is being assessed

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EUROPEAN COMMISSION DG ENTERPRISE AND …

1 EUROPEAN COMMISSION DG ENTERPRISE AND INDUSTRY Directorate F-Consumer Good Unit F3- Cosmetic and Medical …

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Medical Device White Paper Series Medical device clinical ...

MEDDEV 2.7/4 on the need for, and general principles of, clinical investigations MEDDEV 2.7/2 Rev 2 on clinical investigation validation and assessment by competent authorities MEDDEV 2.7/3 Rev. 3 on serious adverse event (SAE) reporting New requirements under the MDR

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Reporting of design changes and changes of ... - meddev.info

(MedDev 2.5/2, latest revision)) The Notified Body should review during audit the operation of the manufacturers system to classify changes as “substantial“ and to inform the Notified Body. The Notified Body should also review those changes considered by the manufacturer as non-substantial and which therefore have not been reported.

  Meddev

Effective post-market surveillance - BSI Group

Vigilance MEDDEV 2.12-1 Post-market clinical follow-up MEDDEV 2.12-1 Reactive PMS Proactive PMS Proactive Reactive • Customer surveys • Post CE mark clinical trials, including PMCF • Manufacturer sponsored device tracking/implant registries • Expert user groups (focus groups) • Customer complaints • Unsolicited user feedback (other ...

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EN 62304 - Frequently Asked Questions - Team NB

See MEDDEV 2.1/6 (chapter 2). 2.1.3 How does the standard distinguish between open and closed systems? Answer: There is no differentiation in the standard between closed or open systems. 2.1.4 Assuming all software has a medical purpose, does the standard apply to the following? a) SAAS

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MedDev 2.7.1 Rev 4 Medical Devices Regulation Clinical ...

MedDev 2.7.1 –6.2.3 Updating the clinical evaluation • design changes or changes to manufacturing procedures (if any) • risks, uncertainties or unanswered questions, in the medium or long term • innovation, changes in clinical sciences, changes in materials sciences

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Do you know the requirements and your responsibilities for ...

May 05, 2017 · 4 Do you now the requirements and your responsibilities for medical device vigilance reporting Considerations To support compliance to the vigilance requirements listed in Table 1, it is important to consider the aspects of a