Clinical Performance Studies with Companion Diagnostic (CDx) Devices
Special considerations for conducting clinical performance studies for companion diagnostics under the European IVDD and IVDR
Australia Will Develop UDI System for Medical Devices Following New Regulatory Amendment
An amendment to Australia's therapeutic goods act 1989 calls for the creation of a unique device identification (UDI) system for medical devices.
US FDA Readies Transition Plans for COVID-19 Medical Device Enforcement Policies
New guidance from the US Food and Drug Administration explains a phased transition plan for medical devices currently covered by agency enforcement policies devised to address the COVID-19 public health emergency.
Norwegian Language Requirement Will Apply Following MDR Implementation
The Norwegian medicines agency (NoMA) has confirmed that, in order to be marketed in Norway, medical devices must include labeling and instructions for use (IFUs) in the Norwegian language.
Annex XIV of the European MDR and Clinical Development Plans for Medical Devices
The European medical devices regulation (MDR) requires manufacturers to establish clinical development plans (CDP). Learn more about EU MDR requirements at Emergo by UL.
New Brazil INMETRO Ordinance Eases Inspection and Documentation Requirements
In Brazil, a new ordinance was published by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO), providing updated conformity assessment standards and documentation requirements.
Eudamed Actor Module FAQ Now Live
The main reason for an economic operator to register in Eudamed has to do with the Single Registration Number (SRN).
MDSAP Council Updates Guidance on Conformity Assessments and Related Requirements
The participating regulators in the medical device single audit program (MDSAP) issued a new guidance documents that is consolidated from two existing documents and expanded with additional annexes.
US FDA 2020 Agenda Includes ISO 13485 Harmonization, De Novo Classification Scheme
The US Food and Drug Administration plans a final rule for De Novo medical device classification as well as a proposed rule for closer harmonization to ISO 13485:2016 quality management system requirements for later in 2020.
Japanese Regulators Extend Medical Device Single Audit Program (MDSAP) Pilot
Updated Japan MHLW requirements for MDSAP report submissions take effect in April 2022