Revision 7 of MEDDEV 2.12-1, the new European Medical Device Vigilance Guidelines, will replace the current version on June 15, 2012. It may lead you to update your vigilance and post-marketing procedures.
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Revision 7 of MEDDEV 2.12-1, the new European Medical Device Vigilance Guidelines, will replace the current version on June 15, 2012. It may lead you to update your vigilance and post-marketing procedures.
In addition to MEDDEV 2.7.1 rev.3, “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies,” that was published in December 2009, a new document (MEDDEV 2.12-2 rev.2) has been published, which describes the sources of data/documentation used in clinical evaluations and the appraisal and analysis of clinical data for CE-marked commercial medical devices.
The 2012 law on financing French social security (the Social Security (...)
A decision, taken by CMC, intended to achieve a common interpretation of the requirement that a manufacturer has in relation to the provision of its address on the label and the instructions for use (IFU)
EU Regulatory Committee on Medical Devices approves regulation on e-instructions for use of medical devices
May 2020 - 17th Notify Body designated by NANDO
MDR 2017/745 postponed till May 2021
March 2020 Update of the list of Notified Bodies accredited by NANDOfor MDR and IVDR
Designation by NANDO of NSAI as MDR NB
DNV GL Presafe (2460), Norway is notified by NANDO to MDR 2017/745
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