Grant Thornton LLP has launched SmartMDR™ and SmartIVDR™, cloud-based
assessment and project management tools, for use by medical device and
diagnostics companies for compliance with the heightened requirements of
the European Union Medical Device Regulation (MDR) and In Vitro
Diagnostic Regulation (IVDR).
Enacted in 2017, the regulations reclassify certain medical devices and
increase the amount of safety and performance evidence that medical
device and diagnostics companies need to demonstrate in order to be
marketed in the European Union.
Companies that cannot meet the new compliance standards will see their
products lose their CE marking – a certification mark that indicates
conformity with health, safety and environmental protection standards
for products sold within the European Economic Area (EEA).
Marty Zuzulo, Compliance Risk director at Grant Thornton, explains, “A
number of factors are combining to create a perfect storm. The
regulations themselves are sweeping – almost a doctrinal shift in
certain areas from previous directives. On top of that, the regulations
diminish the number of notified bodies, or third-party agents, certified
to conduct compliance assessments and audits. The more stringent
regulatory environment and the throttling of the review and approval
‘supply chain’ is creating significant challenges for affected
To achieve or maintain CE marking, companies must assess their technical
files and quality documents against the EU’s MDR and IVDR in a
consistent, structured way. Many business units, and even functions
within the same organization, tend to perform disparate assessments.
“Our SmartMDR and SmartIVDR tools allow for rigor and consistency in
what is a program management challenge within many organizations,” adds
Zuzulo. “They establish a structured, repeatable way for companies to
conduct and capture technical and quality document assessment data – and
to estimate costs and levels of effort to remediate gaps identified in
product compliance assessments.”
Grant Thornton’s solutions also offer the ability for companies to
prioritize the remediation effort by focusing on their most important
products and documents – a critical exercise given the revenue at risk
if companies fail to preserve their product footprint in the EU. The
solutions also provide near real-time project tracking of all critical
remediation efforts and a flexible dashboard with holistic progress
reports toward identified target dates.
Grant Thornton’s SmartMDR and SmartIVDR tools enable companies to
conduct more consistent assessments, which yield higher confidence in
the results, reduce redundant work and optimize resourcing. More
structured estimates and prioritization reduce risk of losing patient
access to products – and improved project tracking capabilities guard
against missed milestones and lapsed CE marking obligations.
“The bottom line is that without overhauling ad-hoc approaches to
product compliance assessments, companies’ revenue is at risk, and they
need a robust way to protect it. These tools can help companies stay
compliant and preserve revenue,” concludes Zuzulo.
For more information about Grant Thornton’s SmartMDR and SmartIVDR
offerings, visit www.grantthornton.com/industries/health-care.aspx.
About Grant Thornton LLP
Founded in Chicago in 1924, Grant
Thornton LLP (Grant Thornton) is the U.S. member firm of Grant
Thornton International Ltd, one of the world’s leading organizations of
independent audit, tax and advisory firms. Grant Thornton, which has
revenues in excess of $1.8 billion and operates 58 offices, works with a
broad range of dynamic publicly and privately held companies, government
agencies, financial institutions, and civic and religious organizations.
“Grant Thornton” refers to Grant Thornton LLP, the U.S. member firm
of Grant Thornton International Ltd (GTIL). GTIL and the member firms
are not a worldwide partnership. Services are delivered by the member
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