EU MDR: Increasing Expectations for Clinical Evidence

While the global medical devices industry is closely watching how the European Union (EU) Medical Device Regulation (MDR) is taking shape, Cactus Life Sciences brings you an informative whitepaper that will help you put all the increasing expectations into context.

The history of what led to creating the EU MDR and the EU In Vitro Diagnostic Regulation (IVDR) is a fascinating, intriguing, and preventable story. It is a story replete with high-profile medical device cases and scandals, often involving implants (e.g., silicone breast, metal on metal orthopedic, and mesh) that proved unsafe in the long-term. Additionally, some manufacturers did not follow through to implement agreed-upon post-market surveillance (PMS) plans. Consequently, these regulations will lead to improvements in the medical device sector. They give manufacturers a final chance to make positive changes before it is too late, and some medical devices have been removed from the market.

Once people finish reading the regulations, standards, and guidance documents, which point out issues and problems, and set expectations, and they put down their red pens and highlighter, they want solutions at a low cost. Then, they need help in creating and implementing their plans.

This whitepaper identifies risk-based solutions that can lead to approvals. Fill out the form below to download the whitepaper.

Why download this whitepaper?

• Identify critical risk-based solutions to ensure sufficient clinical evidence in submissions
• See a visual representation of the most common clinical evidence deficiencies in recent MDR submissions
• Understand how clinical evidence can meet higher standards under EU MDR
• Learn why the traditional equivalence pathway is more difficult to justify
• Compare alternatives to the equivalence pathway across device classes
• Discover key author & reviewer competencies that regulators, notified bodies, and auditors/inspectors look for