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 companies.”
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.
“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 firms. GTIL and its member firms are not agents of, and do not obligate, one another and are not liable for one another’s acts or omissions. Please see grantthornton.com for further details.
