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

  Meddev

Technical Documentation - meddev.info

tions’ see MedDev 2.1/3. (iv) device(s) incorporating non-viable materials of animal ori-gin Where the device(s) incorporates non-viable materials of animal origin, the risk analysis within the technical documentation should address the additional risks and benefits associated with in-corporation of such materials, and the measures

  Technical, Meddev

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

  Question, Frequently, Asked, Frequently asked questions, Meddev

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

  Meddev

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