Blog

Get the latest global medical device regulatory news, insights from our experts, and more.

Jun 3, 2020

Health Canada adds private labels to scope of REP pilot program

The regulator intends to streamline regulatory submissions with the Regulatory Enrolment Program, using an online platform that utilizes extensible markup language (XML) for automated metadata generation.

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Apr 22, 2020

European Parliament officially supports postponing MDR date of application

European Parliament overwhelmingly approves one-year MDR delay
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Apr 22, 2020

European Commission issues new guidance on COVID-19 IVD test performance and validation

European regulators developing EU-wide strategy for use of IVD tests for COVID-19
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Apr 20, 2020

The European MDR and human factors engineering: Use-related risks

Part Three in our series examining human factors engineering (HFE) requirements under the European MDR
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Apr 15, 2020

Exploring the business benefits of inclusive design

Designing medical devices to be accessible to users with special needs has an ethical appeal, but it also can be good for your company's bottom line.
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Apr 15, 2020

Health Canada responds to COVID-19 emergency

The government body has published two Interim Orders along with a series of notices and guidance documents aimed at promoting the supply of necessary medical devices.
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Apr 14, 2020

COVID-19 in Europe: Postponed and remote Notified Body audits for medical device manufacturers

European regulators establish remote, delayed Notified Body audit options with conditions
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Apr 8, 2020

COVID-19 in Europe: Emergency market access for PPE, medical device and IVD manufacturers

Emergency device and PPE access to European markets related to the COVID-19 pandemic
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Apr 8, 2020

India’s CDSCO responds to COVID-19 with new approval, import, and safety measures

A series of notices outline policies designed to promote efficient outbreak response and safeguard employee lives.
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Apr 6, 2020

Has FDA relaxed its human factors expectations in response to the COVID-19 pandemic?

Meeting FDA requirements for human factors engineering and usability during the COVID-19 emergency
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Apr 6, 2020

European Commission officially proposes one-year MDR delay

European regulators officially propose delaying Medical Devices Regulation date of application in order to deal with COVID-19 challenges
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Mar 31, 2020

BARDA opens research portal to combat COVID-19 pandemic

The US government body is seeking input from stakeholders about products and technologies that could play a role in limiting the coronavirus outbreak.
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Mar 26, 2020

Continuing to make progress on human factors work during the COVID-19 pandemic

How to conduct remote usability testing and other HFE activities during the coronavirus pandemic
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Mar 26, 2020

European Commission proposes one-year delay for Medical Devices Regulation

Potential MDR delay reflects shifting EU priorities regarding COVID-19 pandemic
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Mar 25, 2020

COVID-19 Response: What manufacturers should know about US FDA Emergency Use Authorizations (EUA) for medical devices and IVDs

US FDA's Emergency Use Authorization (EUA) pathway allows rapid market entry for medical devices in short supply
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Mar 25, 2020

UK announces COVID-19 regulatory response measures

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new documents and announcements relating to the pandemic.
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