February 24, 2017
On February 22nd, 2017, the texts of the EU Medical Device Regulation and IVD Regulations were published. With the publication, the process for transition is now moving forward. The European Council will meet on March 7th and then the EU Parliament (ENVI) will meet March 20th . Following that the Parliament meets in April and Final Publication in the Official Journal (OJ) is expected in April and May. Notified bodies can only apply to be designated 6 months after adoption and then there are several reviews that are required. Therefore, the timing for Notified Body Designation is approximately 15 months from OJ Publication.
Existing certificates to the MDD or IVDD can be renewed during the transition period valid for up to 5-years, but all Directive certificates will be voided after four years from the full application of the new Regulations.
The new published regulations can be accessed at:
UL is currently a Notified Body under the IVD Directive and Medical Devices Directive and is preparing for designation as a Notified Body under the IVDR and MDR. Please contact us at [email protected] to inquire about our Notified Body services and transfer program.