Question
All Class II devices marketed in the USA must be labeled with UDI bar codes by September 24, 2016--just 19 days away. This announcement summarizes the basic steps for UDI implementation.Step 1: Make a list of all the devices requiring a UDI. A separa...
Even before the FDA’s final rule was published for UDI in 2013, companies were implementing UDI systems. What has not been clear is how the FDA would enforce UDI compliance. The most logical methods of enforcing UDI compliance are:1. require a draft ...
Does anybody have a list of European countries Competent Authorities / Ministry of Health that require further communication/declaration/registration once the CE-mark obtained? Thank you for you help!source: https://www.linkedin.com/groups/2070960/20...
I would appreciate some input as to what other Companies have done in similar situations. An Authority has asked for the ISO 13485 Audit report to be sent in as a part of the Companies Authorization. To start with the Certificate was sent, then confi...
The UK's MHRA has been a leading influence in the European regulation of devices. What does Brexit mean for UK Medtech - and the broader regulation of devices in Europe?Brexit and the CE Mark - implications for European regulation of medical devicesT...
The most common way to answer this question is with a question.How long is a review supposed to take? orHow long does a review actually take?Most people want to know the answer to the second question, and they want real data to back it up. Therefore,...
It's been two years since FDA published its draft “direct to De novo” guidance, on August 14, 2014. Although many of the classification requests that have been submitted since that date are still under review, this seems like a good time to take a pr...
In addition to the qualification requirements for clinical evaluators (prescribed in section 6.4 of MEDDEV 2.7.1 rev 4 which was published June 29, 2016), each of the evaluators must provide a detailed “Declaration of Interest” detailing all relevant...
At the beginning of 2015 I wrote a blog about 510(k) project management (http://medicaldeviceacademy.com/510k-project-management-an-inside-look-at-our-process/) and I recorded a webinar on the topic (http://medicaldeviceacademy.com/510k-project-manag...
Hello all,Maybe this is a basic question for many of you, but I have a doubt regarding the Standards that should be declared on the Declaration of Conformity according with the MDD 93/42/EEC.The Situation is, the harmonized standard EN 60601-1:2006/A...
