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Almost a third of medical device companies not confident on meeting EU deadlines

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New research has revealed that a significant number of European medical device companies are not certain that they will meet two key upcoming deadlines.

The data from RWS shows that 70% of surveyed companies are confident of meeting this month’s medical device regulation update on 26 May 2021.

Meanwhile, a similar 69% feel sure they will meet next year’s in vitro diagnostic regulation deadline on May 26 2022.

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The finding is part of a wider research project looking at the effects the pandemic has had on companies looking to meet these deadlines.

Elsewhere, 44% of surveyed organisations admit the MDR and IVDR regulations are their top priority, and over half (53%) say they will be impacted by both requirements.

Meanwhile, 56% of organisations felt that COVID-19 had a “significant” impact on supply chain management, with 45% of respondents saying COVID-19 had the most impact on their strategic planning for 2021.

Jon Hart, president of RWS Regulated Industries, explained: “While it’s a positive sign that organisations feel optimistic about meeting their MDR and IVDR commitments, there’s clearly a lot of work to do post-pandemic.

“The decisions that medical manufacturing organisations make now won’t just affect their ability to comply with these two regulations, they will also play a continuing role in how quickly and effectively they can meet compliance standards in years to come.

“Introducing automation into the content management and translation process is a good first step, but a more visionary end-to-end solution that spans the manufacturing organisation and the supply chain will better prepare organizations for the inevitable introduction of future regulations.”

RWS published a number of tips for companies looking to meet the deadlines. These read as follows:

  • Automation will be necessary to quickly meet compliance standards during and beyond EU MDR and EU IVDR implementation;
  • Implement new technologies that will give you more visibility into the supply chain. It will also help with compliance and vendor management;
  • Audit the current software and data environment to ensure it enables compliance with these regulations. If not, investments in new solutions or new partnerships may be necessary;
  • Accelerate multilingual content creation with secure automation and technology to support a more streamlined process for internal and external authors, reviewers and approvers of translated content.

Tags : eueuropean unionRWS
Sam Lewis

The author Sam Lewis

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