One year after the EU finalized its new medical device and in vitro diagnostics regulations there has been little progress in helping industry transition to the new regulations, according to MedTech Europe.
Although IVDs have until May 2022 to transition from being CE marked under current regulations to being CE marked under the new regulations, the transition is likely to be further drawn out for IVDs that need to be certified by a notified body, the industry association noted.
“Regulatory documentation — such as Declarations of Conformity, certificates, labels and instruction for use — issued under the current Directive, may remain valid until up to approximately May 2024, and can both continue to be used and will lawfully remain in circulation,” Medtech Europe said in a new paper on the transition process.
IVDs that are not supervised by notified bodies will need to comply from May 26, 2022 onward to be marketed in the EU. The association stressed that the new regulations for devices and IVDs add complexity and secondary legislation is needed to address how some key provisions will work.