Do you know how to use EN62304 (med dvc s/w life-cycle) as implemented under the EU MDD & AIMDD?
Recently it was concluded jointly by industry and European Notified Bodies that there is less clarity in the use of EN 62304 than is desirable. As a consequence, it was decided to start a project to develop a paper with Frequently Asked Questions (FAQ) and answers on the use of EN 62304, especially in the context of CE-marking. This project is a joint undertaking with COCIR (EU Medical Device Industry Trade association) and the EU Notified Bodies for medical devices.
A request for practical questions and issues has just been launched and the invitation letter for FAQ on EN62304 (a short 2 page document) and publication of the FAQ is expected by end of September 2012. The request document is asking for your questions and any proposed answers (if you have those too) to be submitted by the end of May 2012 so you better hop on the bandwagon and get those off to the e-mail address of FAQ62304@VDE.com. I think some of these dates may slip a little but that is not confirmed yet. If I get confirmation of any changes in dates I will advise as soon as I can.
This may sound familiar as this is a similar process to the FAQ document that was issued in Jan/Feb of this year for the EN 60601-1, 3rd ed. Implementation FAQ document.