Archana Nagajaran, Kolabtree
MEDdesign

EU MDR 101: Preparing Technical Documentation

By Archana Nagajaran, Ph.D.

…Under EU MDR September 9: Postmarket Surveillance and Postmarket Clinical Follow-Up September 16: Software and Digital Health Under EU MDRExamples of relevant documents include a device description and specification section…

…Under EU MDR September 9: Postmarket Surveillance and Postmarket Clinical Follow-Up September 16: Software and Digital Health Under EU MDRExamples of relevant documents include a device description and specification section…

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Xavier Duburcq, ProductLife Group
Soapbox

Playing by the Rules: A Lever for Doing Better Business?

By Xavier Duburcq, Ph.D.

…The European Commission’s new MDR, and the equivalent IVDR due to come into force in about two years time, places the onus on device manufacturers to monitor the safety of…

…The European Commission’s new MDR, and the equivalent IVDR due to come into force in about two years time, places the onus on device manufacturers to monitor the safety of…

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Mo Madinejad, Irdeto
MEDdesign

Medical Device Cybersecurity in the Age of IoMT

By Mo Madinejad

…and request companies to share a Cybersecurity Bill of Materials (CBOM) with customers. Figure 3. Evolution of medical device cybersecurity regulations. The EU MDR cybersecurity requirement, which has been postponed…

…and request companies to share a Cybersecurity Bill of Materials (CBOM) with customers. Figure 3. Evolution of medical device cybersecurity regulations. The EU MDR cybersecurity requirement, which has been postponed…

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Carl Ning, Veeva
Soapbox

Postmarket Surveillance: The Urgent Need for a Holistic Approach

…quality, handling complaints and monitoring patient safety. Evolving regulatory requirements such as EU MDR and IVDR, as well as compounding downstream effects of the FDA’s Medical Device Single Audit Program,…

…quality, handling complaints and monitoring patient safety. Evolving regulatory requirements such as EU MDR and IVDR, as well as compounding downstream effects of the FDA’s Medical Device Single Audit Program,…

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Beth Crandall, Maetrics
Soapbox

Economic Operators: New Responsibilities Shake Up MedTech

By Beth Crandall

…under this Regulation.” Under the EU MDR, the authorized representative (AR) must be registered in EUDAMED, or via whatever method of EO registration is required until EUDAMED is available, and…

…under this Regulation.” Under the EU MDR, the authorized representative (AR) must be registered in EUDAMED, or via whatever method of EO registration is required until EUDAMED is available, and…

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GS1, barcode

GS1 Updates Global Model Number Identifier For Use as a Basic UDI-DI to Meet EU MDR Requirements

By Terry Burton, George Wright IV

…is described by the EU MDR as “the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.” It is printed…

…is described by the EU MDR as “the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.” It is printed…

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Clay Moore, Jama Software
MEDdesign

How Effective Collaboration Can Expedite Medical Device Design

By Clay Moore

…issued changes to its 510(k) program, and the European Parliament voted to delay the EU Medical Device Regulation.2,3 Companies who have a centralized approach and real-time access to requirements and…

…issued changes to its 510(k) program, and the European Parliament voted to delay the EU Medical Device Regulation.2,3 Companies who have a centralized approach and real-time access to requirements and…

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Charlie Kim, Soom
Soapbox

How to Get More Mileage Out of Your Electronic IFU

By Charlie Kim

European Medical Device Regulation (EU MDR) will require medical device manufacturers to create electronic instructions for use (eIFUs). To meet this requirement, it’s common for manufacturers to convert their IFU…

European Medical Device Regulation (EU MDR) will require medical device manufacturers to create electronic instructions for use (eIFUs). To meet this requirement, it’s common for manufacturers to convert their IFU…

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Remco Munnik, Iperion
Soapbox

Capitalizing on Standardized International Product Data

By Remco Munnik

…the two resources could make it easier to spot relative product shortages versus availability between different EU markets. Traceability of products is also the major thrust of the new MDR

…the two resources could make it easier to spot relative product shortages versus availability between different EU markets. Traceability of products is also the major thrust of the new MDR

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Adrienne Lovink, Decision Resources Group
Soapbox

2020 Business Outlook: Five Macrotrends Changing the Way Medtech Does Business

By Adrienne Lovink, Lexie Code, Zaid Al-Nassir

…these drivers will be saliently evident, whether through the implementation of the MDR in Europe, the expected ratification of the USMCA in North America, the continued execution of Ayushman Bharat…

…these drivers will be saliently evident, whether through the implementation of the MDR in Europe, the expected ratification of the USMCA in North America, the continued execution of Ayushman Bharat…

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