(New) Setting the Medical Device Lifetime
The Ombu Library has a new article on setting the lifetime of a medical device. This includes issues related to record retention and to risk management. Look in the Medical Device Regulations section.(New) IMDRF Open Consultations
(New) IMDRF Open Consultations
The International Medical Device Regulators Forum (IMDRF) currently has four open consultations. These are opportunities for people to comment on work underway. The consultations are available at http://www.imdrf.org/consultations/consultations.asp
Each consultation includes documents, a comment sheet, and an e-mail address to send the comments.
The consultations are, with their closing dates:
Regulated product submission (RPS) Table of contents June 21, 2013
Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers June 14, 2013
Recognition and monitoring of organizations undertaking audits of medical device manufacturers June 14, 2013
UDI System for Medical Devices July 31, 2013
On June 4, 2013, Dan O’Leary will join a panel of other experts to discuss the UDI Rule and what it means to device manufacturers. The panel discussion is part of the Tenth Annual Medical Device Quality Congress sponsored by FDA News. http://www.fdanews.com/conference/detail?eventId=3232UDI Final Rule Timing
There is a new article in the Ombu Library, in the Medical Device Regulations Section, on the timing of the UDI final rule. FDA plans to issue it by June 30, 2013, but some members of Congress believe the law requires a publication date before May 7, 2013.Updated List of MDD Harmonized Standards
EU Publishes New List of Standards Harmonized to the MDD
On August 30, 2012, the European Union published an updated list of standards harmonized to the Medical Device Directive (MDD).
On July 27, 2012 Health
a. 16 new editions of currently recognized standards were added to replace previous editions;
b. 13 superseded standards were removed.
These changes are required in order to harmonize the list with the previously published guidance on the transition between second and third edition versions of the IEC 60601 family of standards which took effect June 1, 2012.
The recognition document is available as a PDF at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-im/standards-normes/md_rec_stand_im_norm_lst-eng.pdf