ARTICLE SUMMARY:
As the first two devices enter the new EU-wide health technology assessment pathway, experts say they want to know more about how devices are selected, what data will be demanded, and how national authorities will leverage the output. JCAs could help streamline market access but they may also require an earlier focus by firms on collecting comparative data. (Photo: European Union 2013 - European Parliament)
A CE mark allows your company to sell its device across all of Europe, but there is no comparable EU-wide path to ensure adoption and reimbursement of the product. That takes work on a country-by-country basis, where firms face a wide range of procedures and expectations on technology assessment and evidence.
Europe’s many-sided market access landscape presents the steepest challenge for novel devices with higher risk and higher cost, but also higher potential upsides for healthcare. A new mechanism for EU-wide health technology assessments (HTAs) could help align expectations for these products. On the other hand, expert observers suggest the new Joint Clinical Assessments (JCAs) could also end up complicating matters further. The jury is still out as Europe prepares to launch the first JCAs for medtech.
“It’s going to be a ‘learning by doing’ situation where we are going to see how the first JCAs go, how they’re evaluated … to understand the process overall.”
“One of the problems that we have right now is the EU is a very fragmented market and we're hoping that JCAs will help alleviate that to some degree,” Jesús Rueda Rodríguez, MedTech Europe’s director general of industrial affairs and strategies, said in an interview. However, he notes, “We are not quite sure how it's going to play out because it has the possibility of companies being asked for a lot more data, a lot more information that's perhaps not readily available and that doesn't really match up with what we already have developed during the CE marking process.”
