September 28, 2018

UL Signs Memorandum of Understanding with Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Jiangsu, China – Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (Yuwell) has signed memorandum of understanding (MoU) with UL to develop the multi-dimensional cooperation between two sides, aiming to establishing the long-term strategic partnership in the future development. Signed by Mr. Upayan Sengupta, Vice President and General Manager, UL’s Life and Health Sciences business,… read more

September 27, 2018

Medicare and Medicaid Electronic Health Record Software Requirements for 2019

The Centers for Medicare and Medicaid Services (CMS) has declared that a 2015 Edition certified Electronic Health Record (EHR) technology will be required next year (2019 Reporting period). In August 2018 CMS proposed a final rule that would require hospitals and Accountable Care Organizations (ACO*) to upgrade their software solutions to an electronic health record technology that… read more

August 2, 2018

The impact of CMS Updates eCQMs for 2019 Reporting adoption and Interoperability

Summary of key points: Programs affected by the eCQMs updates eCQMs impact on certified Health IT Resources for the updated measures Electronic clinical quality measures (eCQMs) are updated annually by the Centers for Medicare & Medicaid Services (CMS). CMS requires that eligible professionals and hospitals use the most current versions of the eCQMs to be… read more

July 17, 2018

Contract Design Partner Program

Integrating compliance/product certification into the design process – overview In order to provide the shortest design cycles and first-to-market launches, contract designers must process the same amount of work in less time. One possible solution is to redirect the regulatory submission work from the transfer phase to the design and development phase. For example, Medical… read more

June 20, 2018

First UL Cybersecurity Assurance Program (CAP) Certification Issued To ICU Medical’s Plum 360 Infusion System

The UL Cybersecurity Assurance Program (UL CAP) has issued its first certification to ICU Medical, a San Clemente, Calif.-based company specializing in IV therapy products and services. ICU Medical earned UL CAP certification for its Plum 360 drug infusion system, which features closed-system air management intended to minimize patient therapy interruptions, contamination risk, and exposure… read more

June 19, 2018

U.S. FDA Recognizes UL 2900-2-1 for Use in Premarket Reviews

Device submissions to the FDA may now leverage testing and declarations of conformity to UL 2900-2-1 to streamline product review. The announcement follows the FDA’s 2017 recognition of UL 2900-1 and provides manufacturers and developers with tools to meet the FDA’s evolving expectations for medical device cybersecurity risk mitigation. To complete the regulatory approval process,… read more

June 12, 2018

The US FDA has officially recognized the UL 2900 Cybersecurity standard for medical devices

Directly benefitting connected device manufacturers and developers The standard’s adoption will allow US medical device registrants, including manufacturers and developers, to demonstrate proper cybersecurity features within their products. Developed as part of UL’s Cybersecurity Assurance Program (UL CAP), UL 2900 provides registrants with repeatable tests that can provide evidence to support any device cybersecurity claims…. read more

January 24, 2018

What does the European Commission announcement on the withdrawal of the UK from the European Union mean for the MedTech industry?

The European Commission issued the following communication on 10th January: “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products.” This document is not written specifically for the medtech industry but for all sectors, outlining the principles for the withdrawal of the UK from the European Union. The medtech sector has… read more

January 22, 2018

PRESS RELEASE: UL issues first marketing claim verification for Optical Field of View to Visunex Medical System Co., Ltd.

UL, a global safety science organization, has issued the first UL Marketing Claim Verification and UL Verified Mark in the field of medical devices to the Ophthalmic Imaging System, manufactured by Visunex Medical System Co., Ltd. out of Suzhou China. Read the press release here.

August 30, 2017

MHRA launches an introductory guide to the MDR and IVDR regulations

Manufacturers need to demonstrate that their medical device meets the requirements in the MDR or IVDR by carrying out a conformity assessment. The assessment route depends on the classification of the device. Read the full document here

August 30, 2017

PRESS RELEASE: UL Announces GREENGUARD Certification for Medical Devices in Breathing Gas Pathways

UL Environment, a division of UL (Underwriters Laboratories Inc.), a global safety science leader, announced today it has launched GREENGUARD Certification for Medical Devices in Breathing Gas Pathways. Read the press release here.

August 28, 2017

PRESS RELEASE: UL Becomes Recognized Auditing Organization Under Medical Device Single Audit Program

The program allows medical device manufacturers to meet quality management system requirements for multiple geographies in one audit. Read the press release here

August 28, 2017

PRESS RELEASE: U.S. FDA Recognizes UL 2900 for Use in Premarket Reviews

U.S. FDA recognized UL 2900 as a standard for use to test for medical cybersecurity. Read the press release here

June 9, 2017

FDA Reveals list of Devices Requiring Reprocessing Validation

The U.S. FDA, has released a list of reusable devices that must provide validation data for the device’s instructions for use (IFUs) and validation data in their 510(k) premarket notifications submissions.  Dated Friday June 9, 2017, this list includes devices that have a risk of spreading infection if not cleaned properly and design features on those devices that make… read more

May 9, 2017

MHRA issues OBL Guidance as “Virtual Manufacturers” under EU Regulations

MHRA have now issued their guidance explaining how Own Brand Labelers (OBL) are now considered Virtual Manufacturers, adding additional requirements in order to receive certification. Under the new guidance and EU Medical and IVD Regulations, in addition to the contractual review required under the current OBL process, manufacturers must have on hand the product’s full… read more

May 5, 2017

EU IVDR and MDR Published!

After over 8 years of intense negotiation, the text of the IVD and medical device regulations have been published in the Official Journal of the European Union. UL’s Notified Body comments, “Now the real work begins.” Competent Authorities have 80 implementing and delegated acts to write, 14 of which are mandatory. This adds further detailed… read more

March 31, 2017

FDA issues FAQs on MDSAP

In late March, US FDA released a 36-page document containing frequently asked questions (FAQ) on the Medical Device Single Audit Program (MDSAP). The 96 FAQs are organized around three major areas, General, Assessment related and Audits and contain multiple links back to other documents, including the IMDRF documents. Relationships to WHO, ISO 13485, NRTL and… read more

March 31, 2017

UL Achieves Transition Accreditation for the 2016 Version of ISO 13485

Medical device customers can now receive audits and certificates to ISO 13485:2016 to align with global regulatory requirements. >> Click here to view the press release version.

February 24, 2017

EU Medical Regulations Published

On February 22nd, 2017, the texts of the EU Medical Device Regulation and IVD Regulations were published. With the publication, the process for transition is now moving forward. The European Council will meet on March 7th and then the EU Parliament (ENVI) will meet March 20th . Following that the Parliament meets in April and… read more

February 24, 2017

Latest updates from the TC 62 JWG 14 meeting in Berlin

UL Principal Engineer, Pamela Gwynn recently attended the IEC Technical Committee 62 Joint Working Group 22 meetings recently which covered several topics related to IEC 60601. The meeting took place at a technical college in Berlin. The meeting attendees had several opportunities to review technology such as MRI, laser and light, and brain wave measurements… read more

November 15, 2016

UL signs MoU with Seoul National University Hospital

On November 10, 2016, UL and the Seoul National University Hospital (SNUH) signed a Memorandum of Understanding to cooperate on mutually beneficial activities promoting the safe and effective use of medical devices in Korea. SNUH in 2015 set up a “Medical Device Innovation Center” with the Mission “to contribute to advances in human healthcare by… read more

September 7, 2016

INMETRO Ordinance 54 postponed

INMETRO postponed the implementation of the Ordinance 54 that replaces the Ordinance 350. The implementation date is expected to be in 2017. The contents of this new legislation were already made public when it was published months ago. This new Ordinance will introduce new requirements and will inevitably make requirements more demanding. Here are some… read more

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July 19, 2016

CRN Names UL to Develop and Administer Dietary Supplement Product Registry

The Council for Responsible Nutrition (CRN) announced it has retained UL to develop and administer the dietary supplement product registry. Read more   

July 11, 2016

UL office in Warsaw, Poland achieves CBTL status in MED and MEAS

The UL Poland team successfully completed the IECEE audit in June with no findings and is now a CB Test Laboratory (CBTL) under the Medical (MED) and Laboratory (MEAS) categories under the IECEE CB Scheme. The expansion of UL Poland’s CBTL scope includes the 2nd and 3rd editions of IEC 60601-1 and IEC 61010-1 with… read more

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July 8, 2016

FDA extends 60601-1-2 ed. 4 implementation again

In July 2014, FDA added the IEC 60601-1-2:2014 (4th edition) “Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests” to the list of standards that can be used to show EMC compliance for medical electrical devices and systems. The transition at… read more

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