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 »
17 / 10 / 2018 MDR / IVDR Implementation Rolling Plan The European Commission has published a "rolling plan" which provides deadlines and a state-of-play for implementing acts, and other initiatives required in the transitional period. Read more »
10 / 10 / 2018 New MDCG UDI Guidance Documents The MDCG published guidance documents to address various UDI related topics 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 »
30 / 10 / 2018 The new version of the Borderline Classification Manual (v20) was Published Information about the most recent update of the Borderline Classification Manual Read more »