A research report from RWS, the world’s leading provider of technology-enabled language, content management and intellectual property services, highlights the impact of COVID-19 on medical device manufacturers, and their readiness to meet the European Union’s (EU) Medical Device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) deadline.
The research, involving leading medical device organizations operating in Europe, looks at how the pandemic has affected their preparations to meet the 26 May 2021 deadline for the EU MDR, and EU IVDR deadline of 26 May 2022. The research paints an optimistic picture: almost three-quarters (70%) of organizations are positive about meeting the MDR deadline, while 69% remain positive about meeting the IVDR deadline in 2022.
- 44% of organizations admit the MDR and IVDR regulations are their top priority, and over half (53%) say they will be impacted by both requirements.
- 42% say their technology stack evolution is the most important transformation initiative they have put in place to complete EU MDR/EU IVDR compliance.
- 56% of organizations felt that COVID-19 had a “significant” impact on supply chain management. Meanwhile 45% of respondents said COVID-19 had the most impact on their strategic planning for 2021.
- When asked what specific challenges the respondents faced during the COVID-19 crisis, 50% said increased or decreased product manufacturing demand had the most impact on their business.
“While it’s a positive sign that organizations feel optimistic about meeting their MDR and IVDR commitments, there’s clearly a lot of work to do post-pandemic,” explains Jon Hart, President of RWS Regulated Industries. “The decisions that medical manufacturing organizations 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 organization and the supply chain will better prepare organizations for the inevitable introduction of future regulations.”
Meeting the May deadline
Based on the survey results, organizations are advised to explore the following approaches to meet short and long-term commitments:
- 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.
Notes to editors
What is the EU’s Medical Device and In Vitro Diagnostic Regulation?
First published by the EU Parliament in 2017, the European Union’s (EU) Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746) set standards and oversight requirements for manufacturers of medical devices and in vitro diagnostic solutions that intend to distribute their products in the EU. Full details of the EU MDR and IVDR can be found at https://ec.europa.eu/health/md_sector/overview_en
Research report details
This research was conducted by WBR Insights and draws insights directly from members of the medical device and in vitro diagnostics industry who operate in the EU. Respondents were asked how they expect to be impacted by these new regulations and what other companies like theirs can do to move forward.