With the COVID-19 crisis, the implementation of the Medical Device Regulations (MDR) was delayed by one year. This postponement has provided a crucial respite for companies that were not yet prepared for the increased regulatory requirements. However, this delay coincided with the impact of Brexit, creating a unique set of challenges and opportunities for the medical device industry. This webinar will address the current status of the industry regarding MDR and Brexit, and share insights on how companies are preparing for these significant changes.
During the presentation, attendees will gain valuable insights into:
- Additional Requirements in the MDR: Learn about the new and enhanced requirements introduced by the MDR and how they differ from previous regulations. This includes increased scrutiny on clinical evidence, stricter post-market surveillance, and more rigorous requirements for documentation and labeling.
- Brexit’s Impact on UK Submissions: Understand how Brexit is affecting medical device submissions to the UK. The presentation will cover the new regulatory landscape in the UK, including the divergence from EU regulations and the specific requirements for gaining market access in the UK post-Brexit.
- Current Industry Readiness: Discover where the industry stands in terms of MDR readiness. Gain insights into how many companies feel prepared for their first submission under the new regulations and the common challenges they are facing.
- Lessons from Initial MDR Submissions: Hear about the experiences and lessons learned from the first submissions under MDR. This segment will provide practical examples and highlight the key takeaways that can help other companies navigate their own submission processes more effectively.
- Strategies for Saving Time and Money: Explore what other companies are doing now to save time and money in light of the MDR and Brexit. This includes best practices for efficient regulatory compliance, cost-saving measures, and strategic planning to ensure timely market access.
By the end of this webinar, participants will be equipped with a comprehensive understanding of the MDR and Brexit’s impact on the medical device industry. They will learn actionable strategies to enhance their readiness, streamline their submission processes, and ensure compliance with the new regulations. This session is essential for regulatory affairs professionals, quality assurance specialists, and anyone involved in the development and submission of medical devices in the EU and UK markets.