Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices
A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR)...
USA – FDA issues long-awaited device remanufacturing guidance
The US Food and Drug Administration (FDA) has published its final guidance on the remanufacturing of medical devices, adding a new section on regulatory...
UK – MHRA’s AI Airlock to address challenges for regulating AI medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, a new regulatory sandbox, to address the challenges of regulating medical devices...
International – Assessment and Decision Process for the Recognition of a Conformity Assessment Body...
This document defines:
• the process and lifecycle for recognizing, maintaining, or ceasing recognition of a
CAB;
• the process of managing, grading, and closure of assessment...
International – Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies...
This document defines the content of the Regulatory Assessment Program and
provides guidance on the process-based assessment method. The Assessment
Program defines how Regulatory Authorities will...
International – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device...
Standards perform a key role in the conformity assessment process; however, utilizing
existing standards for recognition of medical device CABs performing regulatory
reviews presents challenges. Regulatory...
International – Essential Principles of Safety and Performance of Medical Devices and IVD Medical...
This document applies to all medical devices and IVD medical devices and is intended
to identify and describe essential principles of safety and performance which...
International – Medical Device Regulatory Review Report: Guidance Regarding Information to be Included
The scope of this guidance document is limited to the information participating IMDRF
Regulatory Authorities require in medical device regulatory review reports, the format of
reports,...
International – Final Document- Principles of Labelling for Medical Devices and IVD Medical Devices
The purpose of this IMDRF guidance is to provide globally harmonized labeling
principles for medical devices, including in vitro diagnostic (IVD) medical devices, and
support IMDRF/GRRP...
Europe – Commission welcomes adoption by European Parliament of measures to improve the availability...
The Commission welcomes the adoption by the European Parliament today of measures, proposed by the Commission in January 2024, to improve the availability of in vitro diagnostics...
