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Get the latest global medical device regulatory news from our experts.

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  • Regulatory Update
Jul 28, 2021

The Future of SOP Compliance for Life Science Companies

SOP and learning management system (LMS) strategies for pharmaceutical, medical device and biotechnology manufacturers. Learn more at Emergo by UL and ComplianceWire.
US FDA readies transition plans for COVID-19 medical device enforcement policies
  • Regulatory Update
Jul 6, 2021

US FDA Revokes Emergency Use Authorizations (EUA) for Some Personal Protective Equipment (PPE)

US regulators have revoked emergency use authorizations for some non-NIOSH-approved personal protective equipment (PPE) as the country's COVID-19 public health emergency situation evolves. Learn more at Emergo by UL.
Singapore Skyline
  • Regulatory Update
Jul 1, 2021

Singapore HSA Explains New Developments for COVID-19 Test Kit Authorizations

The Singapore health sciences authority (HSA) announced that it is no longer accepting provisional authorization (PA) applications for COVID-19 test kits.
US FDA Cybersecurity Alert: Risks found in medical device software components
  • Regulatory Update
Jul 1, 2021

US FDA Aims to Improve Cybersecurity Related to Servicing and Maintenance of Medical Devices

FDA seeks feedback from stakeholders on four key cybersecurity issues associated with servicing of medical devices. Learn more about US FDA medical device cybersecurity regulations at Emergo by UL.
European Union
  • Regulatory Update
Jun 30, 2021

EC MDCG Explains Eudamed Requirements for Actors Under MDR, IVDR

New MDCG Q&A explains Eudamed registration requirements and obligations for actors that do not fall under MDR Article 31 or IVDR Article 28. Learn more at Emergo by UL.
Cycotron
  • Regulatory Update
Jun 28, 2021

US FDA Publishes Draft Guidance on Distinguishing Between Servicing and Remanufacturing Devices

The document addresses maintenance activities performed on products that have the potential to impact their regulatory status.
Clinical performance studies with companion diagnostic (CDx) devices
  • Regulatory Update
Jun 23, 2021

Clinical Performance Studies with Companion Diagnostic (CDx) Devices

Special considerations for conducting clinical performance studies for companion diagnostics under the European IVDD and IVDR
Flag of China
  • Regulatory Update
Jun 16, 2021

Chinese Regulatory Bodies Provide Updates on Revised Medical Device Regulations

China's national medical products administration (NMPA) and center for medical device evaluation (CMDE) published announcements and supporting documents relating to State Council Order No. 739, which revised the country's medical device regulations
Flag of Europe
  • Regulatory Update
Jun 16, 2021

European Commission Publishes IVDR Joint Implementation Plan

EC maintains May 2022 date of application for IVDR despite calls for delay
ISO 20916: IVD medical device clinical performance studies at a glance
  • Regulatory Update
Jun 16, 2021

ISO 20916: IVD Medical Device Clinical Performance Studies at a Glance

ISO 20916 provides appropriate IVD medical device definitions and insights on the roles and responsibilities of all involved parties and differentiates interventional CP studies.
IVD devices: From performance evaluation studies to clinical performance studies, what has changed?
  • Regulatory Update
Jun 7, 2021

IVD Devices: From Performance Evaluation Studies to Clinical Performance Studies, What has Changed?

For the marketing of in vitro diagnostic (IVD) medical devices manufacturers need to demonstrate that their products perform as claimed, which typically requires performance data obtained from appropriate studies or from available state-of-the-art literat
Singapore HSA releases draft guidance on medical device UDI system
  • Regulatory Update
Jun 2, 2021

Singapore HSA Releases Draft Guidance on Medical Device UDI System

Singapore's Health Sciences Authority (HSA) published a draft guidance providing a comprehensive view of the upcoming Unique Device Identifier (UDI) system for medical device manufacturers and importers.
European Union
  • Regulatory Update
May 26, 2021

EU MDR Date of Application Roundup: EMDN, eIFUs, UDI Helpdesk, Clinical Investigation

May 26, 2021 has arrived and the European union’s medical devices regulation (MDR) now governs medical devices (including active implantable medical devices or AIMDs).
Placing medical devices on the Swiss market
  • Regulatory Update
May 25, 2021

Placing Medical Devices on the Swiss Market After the EU MDR Date of Application

Under the European Union's Medical Devices Regulation (MDR), Switzerland is currently considered a third country for medical devices. Find out what that means for manufacturers and importers, and how to safeguard obtain the proper clearance to place Europe
Document with an Australian flag
  • Regulatory Update
May 24, 2021

TGA Publishes Guidance Documents for Reclassified Medical Devices

Australia's Therapeutic Goods Administration (TGA) provided information on deadlines and transitional arrangements for three of the six medical device categories slated for reclassification on November 25, 2021.
Map of Switzerland
  • Regulatory Update
May 23, 2021

Consultation Open for Swiss Ordinance Governing IVD Products

The Swiss federal office of public health (FOPH) announced the opening of a public consultation on the draft in vitro diagnostics ordinance (IvDO) and amendments to the ordinance on clinical trials for medical devices (ClinO-MD).
European Commission issues MDR factsheet for Class I medical device manufacturers
  • Regulatory Update
May 19, 2021

European Commission Issues MDR Factsheet for Class I Medical Device Manufacturers

The European Commission has published a new factsheet explaining how the upcoming Medical Devices Regulation (EU) 2017/745 (MDR) will affect manufacturers of low-risk Class I medical devices.
New Saudi medical device regulation
  • Regulatory Update
May 17, 2021

KSA Update: New Saudi Medical Device Regulation, GHTF Applications, AI Requirements, and More

The new regulation retains most of the provisions of the interim regulation and serves as the fundamental basis of the SFDA’s authority to regulate medical devices.
20th Notified Body designated under EU MDR while IVDR designations lag
  • Regulatory Update
May 12, 2021

20th Notified Body Designated Under EU MDR While IVDR Designations Lag

Progress on Notified Body designation continues to raise IVDR capacity concerns
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  • Regulatory Update
Apr 30, 2021

European Commission Issues MDR Q&A Document on Medical Device Clinical Investigations

The European MDCG has issued new guidelines for compliance to clinical investigation requirements under the medical devices regulation (MDR). Learn more at Emergo by UL.