After over 8 years of intense negotiation, the text of the IVD and medical device regulations have been published in the Official Journal of the European Union. UL's Notified Body comments, "Now the real work begins."
Competent Authorities have 80 implementing and delegated acts to write, 14 of which are mandatory. This adds further detailed requirement to the published text so it is important to track these documents as they are published. Notified Bodies can apply for designation 6 months after publication. UL Notified Body estimates that it may take two years to conduct the necessary joint audits of Notified Bodies to enable the designation process to be completed. Manufacturers will need to update all technical files before the end of the transition period and work with Notified Bodies to complete the conformity assessment.
At UL we are looking forward to rising to the challenge and working with our customers to ensure continued market access. If you are interested in receiving more information from UL on Notified Body CE mark certification under either/or the existing EU Directives and/or new medical device and/or IVD Regulations please contact us at [email protected].
Text of the regulations can be found at: