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.

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.

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.

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.

New MDCG UDI Guidance Documents

The MDCG published guidance documents to address various UDI related topics

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.

The new version of the Borderline Classification Manual (v20) was Published

Information about the most recent update of the Borderline Classification Manual


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