One concern we’re hearing is that it may take up to a year and a half for regulatory bodies to become certified to the MDR standards. If the regulatory bodies can’t accept submissions until then, that reduces the submission time for manufacturers with new products down to a year. Keep in mind, the new MDR does provide up to a 5-year transition period for current certificates.
Companies need to start preparing for the changes now, carefully monitoring the status of the NB they select to avoid any costly delays. Basically, you want to be ready to submit to a certified NB for a new application license or retention of license as soon as possible.
There’s also a concern that with fewer total regulatory bodies, high demand could possibly constrain NB resources. The timing and availability of those organizations could impact the product lifecycle process, potentially making the US market more attractive since MDR and FDA requirements are now harmonized.
And while the changes are sweeping for Europe, most of the MDR changes are not new to manufacturing and selling medical devices in the US market. The good news is there’s a good number of industry resources to help with shifting to the US market.
