The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The Commission Regulation of electronic instructions for use (IFUs) of Medical Devices 207/2012 was released 10 March 2012. Here’s a general summary: The directive does not cover
NB-MED issues V1.1 FAQ on Implementation of EN60601-1:2006 w.r.t. MDD
6 Feb 2012 – The NB-MED EN60601-1:2006 issues team released their first official version (V1.1) of this important implementation document in regards to EN 60601-1 with respect to the Medical Device Directive 93/42/EEC (primarily written for this directive) and also
Update on DRAFT NB-MED EN60601 3rd ed. Implementation for EU
16 Jan 2012 Just received an e-mail update on the status of the DRAFT NB-MED document on 3rd edition of EN60601 Implementation for the EU. The pertinent points are: 1) Substantial progress has been made over the last couple months
FDA Extends Comment Period on 510(k) Guidance
On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October
FDA Issues Draft Guidance doc on Mobile “App’s”
On July 21, 2011 the FDA released a draft Guidance document on Mobile “App’s”. There is a 90 day period to submit comments for consideration. (See details on web link for draft guidance). The draft guidance document states in section