January 17, 2019

FDA Proposes to End Temporary Extension of GUDID’s Grace Period to Improve UDI Data Quality

December 18th, 2018, the U.S. Food and Drug Administration (FDA) issued the public notice: Unique Device Identification System: Grace Period Change and Proposed Modifications to the Global Unique Device Identification Database (GUDID), and opened a docket for comments on its proposal to end the temporary extension of the GUDID grace period, which is due January 18th, 2019.

December 13, 2018

Medical Devices and clinical consumables: no-deal Brexit preparation plans update

The Secretary of State for Health and Social Care, Matt Hancock, has recently written to suppliers of Medical Devices and clinical consumables to update them on preparations for a potential no-deal Brexit. This letter explains what the health and care sector needs to consider in the period leading up to March 2019.

November 2, 2018

The new Medical Device and In Vitro Diagnostic Medical Device Regulations (MDR and IVDR, respectively) are coming, is anyone ready?

The new European Medical Device and IVD Regulations adopted in May 2017 replace the existing Medical Devices Directive (MDD), In Vitro Diagnostic Directive and Active Implantable Medical Devices Directive (AIMDD). The new regulatory framework will apply after a transitional period, which ends May 26th, 2020 (May 26th, 2022 for IVDs), and from that date on the new Regulations will fully apply.

October 18, 2018

Did you already start the transition to Medical Device Single Audit Program (MDSAP)? The clock is ticking!

As of January 1st, 2019, Health Canada will terminate the Canadian Medical Devices Conformity Assessment System (CMDCAS) program and Canadian Medical Devices Conformity Assessment System certificates will no longer be issued or accepted.