February 9, 2022 Regulatory Updates
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Medical Devices – USA/Europe Regulatory Updates round up Jan-2022

EUROPE

MDCG 2022-2 – Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)

This document outlines the general principles of clinical evidence and provides guidance on the continuous process of performance evaluation for in vitro diagnostic medical devices, as set out in Regulation (EU) 2017/746.

This guidance describes the approach by which collection, generation and documentation of supporting data for an IVD may be conducted prior to the placing on the market or putting into service.

The target audience of this document is IVD manufacturers, investigators and study sponsors. This document is also intended to inform regulators, notified bodies and other stakeholders when considering clinical evidence provided by manufacturers.

UK (MHRA)

New proposals for the future of UK clinical trial legislation

The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation (until 14 March 2022) into the future of clinical trial legislation in the UK. MHRA is seeking feedback on tens of proposals intended to streamline processes and remove unnecessary burdens to clinical trial sponsors.

Clinical trials are vitally important for achieving advances in medical treatment. Clinical trials may be conducted for a range of purposes, for example to test whether a new treatment or combination of treatments is safe and effective, or to explore new ways to use existing medicines – as has been seen with the rapid introduction of new vaccines and therapeutics for COVID-19

USA (USFDA)

Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA is pursuing various efforts of encouraging voluntary patient engagement in clinical studies, including guidance. FDA believes medical device clinical studies designed with patient input may help to address common challenges faced in medical device clinical studies. While FDA acknowledges that patient engagement may be beneficial across the total product lifecycle, this guidance focuses on the applications of patient engagement in the design and conduct of medical device clinical studies.

This guidance does not address study/research participant or patient advisor reimbursement or compensation, promotion of investigational devices (see 21CFR 812.7), or dissemination of clinical study results.

Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation

FDA is issuing this guidance to describe principles that should be considered when using Patient-Reported Outcome (PRO) instruments in the evaluation of medical devices and provide recommendations about the importance of ensuring the measures are fit-for-purpose.

This guidance is intended to supplement the aforementioned resources by outlining recommended best practices for developing relevant, reliable, and sufficiently robust PRO instruments using the least burdensome approach. This guidance document does not detail the methods and steps of developing, modifying, or adapting a PRO instrument.

Principles of Premarket Pathways for Combination Products

FDA is publishing this guidance as part of its efforts to implement Cures Act section 3038 and in keeping with the Agency’s long-standing commitment to transparency, efficiency, and regulatory consistency, to facilitate development of safe and effective combination products.
T
his guidance offers general, high-level information regarding what combination products are, coordination within FDA and interaction between FDA and sponsors regarding combination product regulation, and how combination products are reviewed by FDA before they are marketed. The remainder of this guidance focuses on how to determine which type of premarket submissions may be appropriate for combination products.

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