Almost three-quarters of medical device companies ready to meet the European Union’s MDR and IVDR regulations
Despite optimism, almost half admit COVID-19 will have long-term impact on strategic planning
Chalfont Saint Peter, UK
10 May 2021
- 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.
- 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.