Final MDCG Guidance on Borderline Published Under Regulation (EU) 2017/745 on Medical Devices Final MDCG Guidance on Borderline Published Under Regulation (EU) 2017/745 on Medical Devices The European Commission (EC) has published the... Final MDCG Guidance on Borderline Published Under Regulation (EU) 2017/745 on Medical Devices
PAGB Briefing Paper on Titanium Dioxide PAGB Briefing Paper on Titanium Dioxide PAGB has released a briefing paper in response to the ban of titanium dioxide... PAGB Briefing Paper on Titanium Dioxide
EUDAMED – European Medical Device Nomenclature Q&A Infographic EUDAMED – European Medical Device Nomenclature Q&A Infographic The Commission has released a European Medical Device Nomenclature (EMDN) infographic outlining... EUDAMED – European Medical Device Nomenclature Q&A Infographic
MDCG International Matters Working Group – EU-Turkey Customs Union Agreement MDCG International Matters Working Group – EU-Turkey Customs Union Agreement in the Field of Medical Devices The European Commission has... MDCG International Matters Working Group – EU-Turkey Customs Union Agreement
Plastic Packaging Tax – Updates Plastic Packaging Tax – Updates In light of the new Plastic Packaging Tax (PPT), which took effect from 1 April... Plastic Packaging Tax – Updates
EUDAMED – Technical Documentation Updates EUDAMED – Technical Documentation Updates EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745... EUDAMED – Technical Documentation Updates
EUDAMED – UDI Devices User Guide (V2.7) EUDAMED – UDI-Devices User Guide (V2.7) The UDI (Unique Device Identification) system is a new feature introduced by the MDR... EUDAMED – UDI Devices User Guide (V2.7)
EUDAMED – Commission Website Dedicated to Actor Registration Module Available – Updated FAQs Published (V8) EUDAMED – Commission Website Dedicated to Actor Registration Module Available – Updated FAQs Published (V8) The Commission has updated the... EUDAMED – Commission Website Dedicated to Actor Registration Module Available – Updated FAQs Published (V8)
MHRA Consultation on a New Code of Practice for the Expert Advisory Committees MHRA Consultation on a New Code of Practice for the Expert Advisory Committees MHRA is inviting a range of stakeholders... MHRA Consultation on a New Code of Practice for the Expert Advisory Committees
EU MDR/IVDR Implementation – MDCG Groups Update EU MDR/IVDR Implementation – MDCG Groups Update The EU Commission has updated the document ‘Ongoing guidance development and deliverables of... EU MDR/IVDR Implementation – MDCG Groups Update
EU Commission Updates the Rolling Plan Containing List of Essential Implementing Acts for the EU MDR European Commission Updates Rolling Plan The European Commission has updated the Rolling Plan (as of April 2022)... EU Commission Updates the Rolling Plan Containing List of Essential Implementing Acts for the EU MDR
IVDR Implementation – Joint Implementation and Preparedness Plan for IVDR Updated IVDR Implementation – Joint Implementation and Preparedness Plan for IVDR Updated The Commission has published an updated version of the... IVDR Implementation – Joint Implementation and Preparedness Plan for IVDR Updated