The European Council has reached a political agreement on the proposed/draft Medical Devices and IVD Regulations. The press release, issued May 25th, 2016 marks the end of the wait of the question of when the restructuring that began in 2012 would be put into place. However, although agreement has been met, there are still some further actions that must take place before the regulations are finalized.
There is still translation work that needs to be completed before it can go into its official first reading, which is expected to be done over the summer. That would put at the earliest, a first reading in the October time frame and the second reading by the end of the year. According to Sue Spencer, Head of UL’s Notified Body, “Notified Bodies cannot apply to be designated for six months whilst the implementing acts are prepared and then Notified Bodies will need additional designation audits.”
So while we now know that the regulations will be put into place, there are still open questions about the specific timing and the final details of the text; however, the time has come to accept that this is finally happening and start preparing.
Read UL’s white paper on the changes to the EU regulatory system at: https://library.ul.com/?document=the-changing-landscape-of-medical-and-in-vitro-diagnostic-device-regulations-in-the-european-union