Medical device approval in Europe, US and Japan: similarities and differences

Medical device approval in Europe, US and Japan: similarities and differences - Myriam Stieler

9:45 AM - 10:30 AM


Under the current market restrictions and price decline, a fast and efficient way to get market approval for medical devices is more important than ever. Thus many companies aim for parallel approvals in as many markets as possible.
Previously, Europe was the preferred place to conduct the first clinical studies and get the first market approval, but EU regulatory requirements have now become stricter. After the recent medical device scandals, more stringent guidelines and regulations were released such as MEDDEV 2.7/1 revision 4 and the new Medical Device Regulation (MDR 2017/745). At the same time, the US FDA slightly lowered the requirements for clinical studies and market approval.
Furthermore, through the US and Japan Medical Device Harmonization by Doing (HBD) program, the FDA, Japanese regulators, academia, and industry developed internationally agreed standards for global clinical trials, and addressed regulatory barriers that may delay timely medical device approvals in both countries. HBD has a working group focusing on moving Japanese and US clinical study sponsors and regulatory agencies towards the use of a single global clinical trial protocol for evaluating medical devices rather than parallel country-specific protocols. This means that the FDA may accept data from Japan when using the joint protocols (of note, some data from Europe is also accepted in case the European and US-protocols are identical and aligned with US regulations). This will certainly facilitate device approval in both the US and Japan, and will foster the time- and cost-effective generation of clinical datasets relevant for device approvals.
In a nutshell, the medical device landscape is changing. While Europe was the predominant geography for clinical studies and early device approvals in the past, we will likely see a shift towards more clinical studies conducted in the US and Japan. Therefore, familiarity with European, as well as US and Japanese regulations is more important than ever, especially for medical writers.
This ESS will discuss the differences and similarities of the approval processes in all three markets, the essential requirements, and the processes that can be combined to target a fast and efficient market authorisation in all three regions.