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EC Decision on Standardization for Medical Devices

The European Commission (EC), the medical device regulating authority of the European Union, issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation...

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EC Amends Notified Bodies Designation Procedure

The European Commission (EC), the EU body responsible for medical devices regulatory framework, announces amendments to the designation procedures related to the Notified Bodies (NBs), and also to the rules on the EU-wide derogations. EC New Regulations in Brief Both...

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EU Council Proposal on Regulation Implementation Dates

The Council of the European propose to amend the dates of application of certain provisions of the Medical Devices Regulation 2017/745 (MDR) superseding the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Regulation 90/385/EEC in...

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