EU-MDR’s Growing Pains: Are You Current with the Latest Developments? – Webinar Recording/Transcript
Feel bogged down by countless EU-MDR guidances, standards and notified body (NB) interpretations? Get a handle on it all — and stay compliant — with this presentation.
Any new regulation can give rise to references devicemakers must stay on top of, and one of this magnitude has prompted a seemingly endless amount.
This presentation by James Pink, senior director, medical at Element Materials Technology, will provide you with the information and strategies to stay compliant in the EU now … and going forward as the regulation evolves.
Consider this: if you’re behind in applying for a CE Mark, NB figures show that such a delay may put your device squarely in the thick of an enormous backlog that will impede its review. And there are countless other considerations you must think through.
Mr. Pink will put all of this into context. He’ll share how you can stay on top of the EU-MDR requirements through a carefully designed strategy for regulatory compliance. He’ll explain the constantly evolving guidances and references. And he’ll disclose how the requirements will likely continue to develop so you can stay compliant.
- The regulatory framework around the EU-MDR, including common specifications, guidances, harmonized standards and interacting EU laws
- How to develop an effective and value-added strategy for regulatory compliance, including developing tools and systems to track regulatory updates, setting equivalence requirements managing changes to standards and medical state of the art good practices
- How to plug into those aspects of EU regulations you may not have known exist but are essential, including the forthcoming Artificial Intelligence Act, cybersecurity frameworks, data protection law and hazardous substance requirements
- The value — and pitfalls — of notified body, competent authority and the Medical Device Coordination Group (MDCG) guidances, including the diverging opinions on sufficient clinical evidence, substantial changes and the influence of national competent authorities
- The regulatory technologies now available to you to support your strategy for regulatory compliance, including regulatory intelligence systems, standards updates and regulatory affairs software
Compliance is possible only when you’re on top of all the EU-MDR developments. Here’s how to get — and stay — there.
Meet Your Presenter
James Pink is senior director, medical at Element Materials Technology. He has more than 25 years of experience in medical technology product safety, quality and regulation. He is an active participant in future medical technology regulation and standards, with significant experience of European regulation, the operation of notified bodies and product liability in the field of medical devices.
Who Will Benefit
- Development directors/engineers
- Quality assurance personnel
- Regulatory affairs personnel
- Clinical associates
- Research and development personnel
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July 28, 2022