EUDAMED – Production Release 2.10 EUDAMED – Production Release 2.10 EUDAMED is the IT system developed by the European Commission to implement... EUDAMED – Production Release 2.10
MHRA – Impact of Extension of Medical Device Regulations Transitional Period and the Validity of Certificates in the EU MHRA – Impact of Extension of Medical Device Regulations Transitional Period and the Validity of Certificates in the EU The... MHRA – Impact of Extension of Medical Device Regulations Transitional Period and the Validity of Certificates in the EU
EU – Overview on Applications for Designation as a Notified Body EU – Overview on Applications for Designation as a Notified Body An overview on the applications for designation as a... EU – Overview on Applications for Designation as a Notified Body
Tenth Notified Body Designated Under EU IVDR Tenth Notified Body Designated Under EU IVDR Slovakia-based Notified Body ‘3EC International` has been notified as the 10th Notified Body... Tenth Notified Body Designated Under EU IVDR
MDR/IVDR Implementation – European Parliament In Favour of Commission Proposal to Amend the Transitional Provisions MDR/IVDR Implementation – European Parliament In Favour of Commission Proposal to Amend the Transitional Provisions Following the Commission adopting a... MDR/IVDR Implementation – European Parliament In Favour of Commission Proposal to Amend the Transitional Provisions
Ninth Notified Body Designated Under EU IVDR Ninth Notified Body Designated Under EU IVDR Germany-based notified body ‘MDC MEDICAL DEVICE CERTIFICATION` has been notified as the 9th... Ninth Notified Body Designated Under EU IVDR
MHRA Webinar Recording- Medical Devices Regulations – Tuesday 24 January 2023 MHRA Webinar Recording – Medical Devices Regulations – Tuesday 24 January 2023 On 24 January MHRA hosted a Medical Devices... MHRA Webinar Recording- Medical Devices Regulations – Tuesday 24 January 2023
EU MDCG 2023-3 Questions and Answers on Vigilance Terms and Concepts EU MDCG 2023-3 Questions and Answers on Vigilance Terms and Concepts The Commission has published a new document:... EU MDCG 2023-3 Questions and Answers on Vigilance Terms and Concepts
EU Commission – CLP Revision – Public Consultation Deadline Extended EU Commission – CLP Revision – Public Consultation Deadline Extended In December 2022 the European Commission published its proposal for... EU Commission – CLP Revision – Public Consultation Deadline Extended
MHRA Consultation on Proposals to Increase Statutory Fees – Government Response MHRA Consultation on Proposals to Increase Statutory Fees – Government Response The government response to consultation on proposals for changes... MHRA Consultation on Proposals to Increase Statutory Fees – Government Response
Government Response to Regulatory Horizons Council Medical Device Report Government Response to Regulatory Horizons Council Medical Device Report The Regulatory Horizons Council (RHC) published a report containing recommendations on... Government Response to Regulatory Horizons Council Medical Device Report
MDR Implementation – Coverage of Designation Codes by NBs MDR Implementation – Coverage of Designation Codes by NBs The European Commission has published an updated summary on coverage of... MDR Implementation – Coverage of Designation Codes by NBs
