The EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) may cause a “cliff-edge scenario,” meaning a disruption in the supply of certain medical devices and IVDs, industry groups and the European Commission (EC) recently cautioned.
Experts see the potential for such disruptions because of roadblocks in transitioning to the new regulatory framework, including notified body (NB) designation delays. And although these issues have come under the spotlight, amid what the industry calls a “clearly untenable” transition, early work on MDR/IVDR may make submissions in other countries more appealing for manufacturers.
“Once a company is early in getting MDR, their standing in some countries where registration relies on CE marking might go up,” executive director and partner at Qserve consultancy and RAPS board member Gert Bos told Focus. At least some of the countries that permit CE-marked devices to be used on their market in lieu of regulatory reviews or conformity assessments include India and Jordan.
Bos added that “if competitors are slow in getting to MDR, an advantage in gaining market share is a possibility worth thinking about.” The other side of the story is that once a few competitors show MDR compliance, others that do not “might start losing market share.”
As seen from the EC’s recent factsheet to health care providers and health institutions and the European Association of Notified Bodies’ (Team-NB) member survey results, manufacturers and NBs alike face difficult decisions with the new regulations…