While the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) is now in effect, stakeholders are concerned that the road forward is not going to be easy, especially due to the lack of notified body capacity to handle the influx of conformity assessments necessitated by the new regulation.
On 26 May, medtech manufacturers, notified bodies and regulators woke up to a brave new world where IVDR is the law of the land. Under the regulation, new diagnostic devices, legacy devices and existing devices will be regulated under a framework that EU regulators assert is fairer, more streamlined and better for patients.
“The rules will better protect public health and patient safety in respect to these devices, bringing EU law in line with technological advances and progress in medical science,” said the European Commission. “By aligning market access requirements in the different EU Member States, it also safeguards fair market access for manufacturers.”
But that’s easier said than done, according to industry experts who have been tracking the issue for years…
