13 / 03 / 2019 Corrigenda to the Regulations The Council of the European Union released two corrigenda as part of an effort to fix the mistakes, inconsistencies and slightly correct the EU’s Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR). Read more »
04 / 03 / 2019 Medical Device Nomenclature The Italian CND nomenclature is selected to support the IVDR and MDR implementation. Read more »
01 / 02 / 2019 New version of the Borderline Classification Manual (v21) Published The European Commission published a new revision (1.21) of the “Manual on borderline and classification in the community regulatory framework for medical devices.” Read more »
01 / 02 / 2019 No-deal Brexit Impact. The European Commission has posted on their website a Questions and Answers related to the UK’s withdrawal from the EU, in case of a no-deal scenario. While in the UK, new regulations that amend their 2002 Medical Device Regulations were laid down in parliament. Read more »
19 / 12 / 2018 EU Commission publishes new MIR template The new template for a Manufacturer Incident Report (for MDD/AIMDD/IVDD incidents or MDR/IVDR serious incidents) was published, along with a help text on how to complete the new form. Read more »
15 / 11 / 2018 EU Commission publishes new FSN template The European Commission has posted new templates for a Field Safety Notice (FSN), for customer and distributor/importer reply forms as well as a Frequently Asked Questions (FAQ) on how to fill in the FSN on their website. Read more »
25 / 10 / 2018 EU Parliament debates questions regarding MDR/IVDR implementation. The Commission responded to the oral question of the Parliament on how it sees the IVDR/MDR implementation. Read more »