2017/745 - EN - Medical Device Regulation - EUR-Lex
May 5, 2017 · However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices …
Overview of Device Regulation | FDA
Jan 31, 2024 · Overview of regulations for medical devices: premarket notifications (510 (k)), establishment registration, device listing, quality systems, labeling and reporting requirements.
The U.S. FDA Regulatory Landscape for Medical Devices
Nov 24, 2025 · Medical devices are governed by diverse regulatory systems worldwide. Europe’s Medical Device Regulation (MDR) has elevated requirements around clinical evidence, post …
Medical Device Regulation
The objective of the conformity assessment based on product conformity verification is to ensure that devices conform to the type for which an EU type-examination certificate has been issued, …
Jan 4, 2023 · Medical device manufacturers are subject to a range of regulatory controls (i.e., requirements) to ensure that devices are not adulterated or misbranded and to otherwise …
Facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer …
eCFR :: 21 CFR Chapter I Subchapter H -- Medical Devices
Learn more about the eCFR, its status, and the editorial process.
Navigating U.S.-EU Medical Device Regulation: Innovative …
Nov 18, 2025 · The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation (MDR) and the FDA’s Quality …
Is Your Product Regulated? | FDA
Most of FDA's medical device and radiation-emitting product regulations are in Title 21 CFR Parts 800-1299. These final regulations codified in the CFR cover various aspects of design,...
Guide to Medical Device Regulation | Thompson FDA
Thompson's Guide to Medical Device Regulation contains the highest quality analyses on the regulation of medical devices — including how the courts and the FDA interpret and enforce …