his transition page will be updated regularly with the latest facts. BSI will run a series of webinars and white papers to ensure we share valuable information with you regarding these significant changes.
The official non-BSI websites can also provide additional background and detailed information:
Competent authority, MHRA
Read the final EU Commission text.
If you have questions regarding the changes please contact your BSI Scheme Manager for initial questions.
The original proposal documents can be found via the following pages.
MDD-IVDD communication 2012-540
IVDD Regulation proposal 2012-541
MDD Regulation proposal 2012-542