MD2: Global development strategy – Which market should you go to first?
Leader and Chair: Natasha Bankowski, Head of Global Regulatory Affairs and Pharmacovigilance, Kora Healthcare, Ireland
For medical device manufacturers, gaining access to multiple major markets is important for the success of the company. Global differences in regulations and requirements typically result in a long and costly path to global regulatory approval.
Taking a strategic approach in achieving regulatory approval can be an effective tool in reducing the compliance burden facing medical device manufacturers.
Manufacturers may find that first obtaining FDA or EU approval for access to the US or European market can result in leveraging documentation required for the prompt and efficient review of new device applications in other markets.
The decision where to start (whether EU first, US first, or simultaneously) has different advantages that need to be considered and must be assessed on a case-by-case basis, depending on the characteristics and features of your device, your company setup, and the corresponding regulatory control.
For the last number of years, many companies would have obtained EU approval first before approaching the FDA/ROW markets. However, with the introduction of the EU MDR and the United Kingdom leaving the European Union, more and more companies are now choosing the US as the preferred initial market due to the additional restrictions and complexities that the EU MDR and Brexit have brought.
16:05 US as first choice for your new medical device rather than EU! Is this a good or bad choice? – Michelle Lott, Regulatory Strategist, Principal and Founder, Lean RAQA, US
- Need for a market analysis to make a business case for the EU/UK market compared to US with regulatory AND reimbursement considerations
- Considerations of companies holding valid MDD certs vs. companies new to the EU market
- Compare and contrast bringing a product to market with the FDA vs Notified Body
16:25 How does the MDR impact your overall global development strategy? – Bassil Akra, Chief Executive Officer, AKRA TEAM, Germany
- Specific and evidence-based claims
- Higher Clinical and PMS Requirements
- Long certification timelines impacting registration and non-EU market access
16:45 As the UK has now left the United Kingdom with NI still following EU rules? Where does UK now fit into your global development strategy? – Monisha Phillips, Head of MHS Certification Body, TUV SUD, UK
17:05 Panel discussion
- What are the UKCA requirements for medical devices?
- When do manufacturers need to act?
- What next?