The UK’s innovation agency Innovate UK has warned that Britain is not ready for implementation of the Medical Device Regulation (MDR), despite COVID-19 pushing this key date back.
The MDR (Regulation (EU) 2017/745) designed to improve the systems underpinning the regulation of medical devices around Europe, including creating unique device identifiers for tracking purposes and boosting the data required for registration.
Crucially, the MDR is such a departure from the previous legislation that new responsible organisations, known as notified bodies, need to be registered or converted, in order to manage the new system.
Innovate UK conducted a survey to understand companies’ readiness for the new system. Innovate UK said:
“The survey found that the majority of the UK SME medical devices sector was severely underprepared with many lacking an understanding of the extensive changes required for MDR compliance.
“Case studies give real insights into the business impact, which inevitably ends up as patient impact. The assessment found that revenues are likely to fall as a result of the significant financial cost of compliance with MDR. The cost of compliance will likely result in companies discontinuing products and the financial impact may fundamentally threaten the viability of SMEs beyond May 2020 [sic].”
Recommendations to resolve the under-preparedness include:
- Education: Beyond awareness to product and business specifics
- Funding: Supporting compliance activities and program design and delivery
- Acceleration: Guided implementation and access to specialist expertise
- Mitigation: Urgent action planning with the MHRA, BEIS, OLS, DHSC & NHS organisations
Read the Innovate UK report for more information