Across the EU, UK and China, significant changes to the existing medical device regulatory landscape are underway or fast approaching.
In the wake of the COVID-19 pandemic, with new regulation in the EU and Asia, and Brexit in the UK, many manufacturers have questions about the implications of recent and forthcoming changes, such as:
- What is required to comply with the EU MDR?
- How can I prepare for the EU IVD Regulation coming into force in May 2022?
- What are the continuing implications of Brexit?
- Does the EU’s new Directive on Representative Actions increase the risks for my business?
- How does China State Council Order 739 affect medical device registration and approval?
Join our webinar to hear more about these developments, or submit your questions in advance for discussion by our expert panel.
Presenter: Elisabethann Wright, Partner, Cooley
Elisabethann Wright specializes in EU law and regulation of pharmaceuticals and medical devices and is regularly sought-after and praised for her knowledge of the legislation, technical competence and commercial acumen. She has been practicing in the life sciences sector for over 35 years in private practice and international institutions.
Elisabethann helps clients navigate the process and regulations to place and keep their products on the European Union market through strategic advice, advocacy before institutions and agencies and litigation before EU courts.
Presenter: Edward Turtle, Associate, Cooleyha
Edward Turtle is a products lawyer, regulatory advisor and litigator with particular experience in the technology, healthcare and consumer product sectors.
Edward helps clients with compliance and safety issues, including in the development, launch and marketing of new products. He undertakes European policy work, advising stakeholders on submissions in the context of forthcoming legislation and guidance. Edward is experienced at dealing with regulatory authorities and handling product crises, including global recalls and mass consumer claims.
Presenter: Amy Chen (Pei Yu Chen), Regulatory Consultant, Compliance & Risks
Amy is a Regulatory Consultant with Compliance & Risks, specializing in consumer products compliance, focusing on China, Taiwan, and other Asian countries.
She helps product manufacturers to identify and understand the regulations in place in the markets to which they sell by helping them to map their obligations with regard to product safety (chemicals, EMC, radio frequency), labeling, energy efficiency, waste and packaging. Amy is a native Chinese speaker and has a Master of International Commercial Laws from the University of Limerick, and a Bachelor of Law degree from University College Cork.