MDR & IVDR - A Rising Tide of Content

Content Requirements Under MDR…And What You Can Do About It

Learn what content changes are coming under MDR for your Labeling, Marketing, and Post-Market Surveillance materials, as well as technology and process recommendations for what you can do about it...right now!
 

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Content Requirements under MDR

MDR Requirements and What You Can Do

Labeling: Volume & Velocity

"Based on expert opinion from noted regulatory resource Qserve, the MDR/IVDR are expected to increase both the volume and velocity of device-related content, while also increasing the amount of regulatory scrutiny applied. The expected result will be an industry-wide drive to deliver expanded throughput, flexibility, quality, and control via content centralization and automation."

— Medical Device Content & Communications Under MDR/IVDR

Marketing: Controlled

"Article 20(5) of the MDR mandates that the CE Mark be included in promotional material that mentions that the device fulfills CE Marking requirements. This change illustrates the “regulatory drift” toward considering promotional material more as product labeling...As such, promotional materials are subject to controls, such as regulatory affairs review and approval."

— Medical Device Content & Communications Under MDR/IVDR

Training: E-Learning

"The extent and volume of regulatory changes due to MDR/IVDR is expected to drive an increase in training requirements in key areas, such as sales, clinical, and corporate compliance. In order to automate record-keeping and ensure training compliance, many manufacturers have implemented computer-based learning management systems (LMS). It is expected that translated/localized e-learning courses will be extensively utilized to demonstrate conformity with new regulatory requirements."

— Medical Device Content & Communications Under MDR/IVDR

Translations: Clear, Comprehensible

"Under prior regulation (MDD), content language requirements were vaguely assigned to the member states. Now, the MDR itself contains 25 explicit references to language requirements, including labeling and product information...Note: new requirement for "clear comprehensibility"—raising the quality threshold for translated content."

— Medical Device Content & Communications Under MDR/IVDR

MDR & IVDR

MDR & IVDR are driving industry change at a scale and scope not seen since medical devices were first widely regulated in the early 1970s. The cost of compliance for these new regulatory requirements has been estimated at 3–5% of global industry revenue. In other words, up to $20 billion.

A significant portion of MDR & IVDR compliance cost is due to new content requirements—including requirements for additional types of labeling and public-facing risk reporting—and all subject to stricter translation requirements.

Compliance with the new regulations is not a “one and done” effort. Due to expanded post-market requirements, experts project a 320% increase in annual updates to technical files and related documents, including labeling.

Labeling: Volume & Velocity

"Based on expert opinion from noted regulatory resource Qserve, the MDR/IVDR are expected to increase both the volume and velocity of device-related content, while also increasing the amount of regulatory scrutiny applied. The expected result will be an industry-wide drive to deliver expanded throughput, flexibility, quality, and control via content centralization and automation."

— Medical Device Content & Communications Under MDR/IVDR

Marketing: Controlled

"Article 20(5) of the MDR mandates that the CE Mark be included in promotional material that mentions that the device fulfills CE Marking requirements. This change illustrates the “regulatory drift” toward considering promotional material more as product labeling...As such, promotional materials are subject to controls, such as regulatory affairs review and approval."

— Medical Device Content & Communications Under MDR/IVDR

Training: E-Learning

"The extent and volume of regulatory changes due to MDR/IVDR is expected to drive an increase in training requirements in key areas, such as sales, clinical, and corporate compliance. In order to automate record-keeping and ensure training compliance, many manufacturers have implemented computer-based learning management systems (LMS). It is expected that translated/localized e-learning courses will be extensively utilized to demonstrate conformity with new regulatory requirements."

— Medical Device Content & Communications Under MDR/IVDR

Translations: Clear, Comprehensible

"Under prior regulation (MDD), content language requirements were vaguely assigned to the member states. Now, the MDR itself contains 25 explicit references to language requirements, including labeling and product information...Note: new requirement for "clear comprehensibility"—raising the quality threshold for translated content."

— Medical Device Content & Communications Under MDR/IVDR

You Can’t Meet a 21st-Century Requirement with a 16th-Century Process

Unfortunately, your content creation and management systems are still stuck in the dark ages—traditional systems like Word, InDesign, or even FrameMaker create documents. The content in each document is siloed from every other document, leading to fragmented, inconsistent information that must be changed and managed document-by-document using manual processes.

A cure for the Mdr & ivdr headache

Fortunately, technology now exists to help you deal with the pain of MDR & IVDR content requirements: XML structured content, automated publishing, and translation process automation (including advanced AI). Our new EnCompass System combines them all into a modular solution, specifically designed to reduce content cost, risk, and turnaround by over 50%.

Let's get in touch

A cure for the Mdr & ivdr headache

Fortunately, technology now exists to help you deal with the pain of MDR & IVDR content requirements: XML structured content, automated publishing, and translation process automation (including advanced AI) – our new EnCompass System combines them all into a modular solution, specifically designed to reduce content cost, risk, and turnaround by over 50%.

Let's get in touch

A cure for the Mdr & ivdr headache

Fortunately, technology now exists to help you deal with the pain of MDR & IVDR content requirements: XML structured content, automated publishing, and translation process automation (including advanced AI) – our new EnCompass System combines them all into a modular solution, specifically designed to reduce content cost, risk, and turnaround by over 50%.

Let's get in touch

EnCompass System for MDR & IVDR Compliance

EnCompass is a modular solution that combines XML content management and automated translation processing (including GlobalLink AI™ and business intelligence reporting). EnCompass is built with open APIs and is easily integrated with downstream labeling and e-IFU systems.

A manufacturer of professional audio equipment had their audio guru listen to the Sheersound codec and his opinion was:
‘The audio quality is
definitely at a high
professional level‘

Let's get in touch

Learn how EnCompass supports digital transformation for your content

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