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).

Medical Device Nomenclature

The Italian CND nomenclature is selected to support the IVDR and MDR implementation.

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.”

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.

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.

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