The European Parliament on Thursday voted overwhelmingly in favor of a proposal by the European Commission to extend the transition period of the In Vitro Diagnostic Medical Devices Regulation (IVDR) and hasten the application of EUDAMED requirements.
Members of parliament voted 511-1 with 21 abstentions in favor of the Commission’s proposal, giving test makers additional time to transition to the new regulation. With the Parliament’s adoption of the proposal, the European Council is expected to adopt the measure; it will take effect upon publication in the Official Journal of the European Union.
“I warmly welcome today’s adoption by the European Parliament of this amending Regulation. In a strong European Health Union, essential medical devices and diagnostics must be available for patients at all times. Today’s adoption will help to ensure patient safety, grant more time to manufacturers to adapt to new rules on medical devices, and give more time for healthcare systems to take appropriate actions when devices are discontinued. I call on the Council to adopt the proposal as soon as possible so that the provisions can enter into force without delay,” said Stella Kyriakides, Commissioner for Health and Food Safety.
Under the transition measures, high-risk class D diagnostics would get until December 2027 to undergo a conformity assessment under IVDR; class C, or high individual and/or moderate public health risk tests, will have until December 2028, and low risk class A sterile and class B tests would have the deadline extended to December 2029.
“The measures give more time to consider possible actions to safeguard patient care in instances where certain devices are discontinued and increase transparency regarding medical devices on the market,” the Commission wrote, welcoming the Parliament’s vote.
The proposal also includes a requirement for manufacturers to provide regulators with 6 months advanced notice when they anticipate a supply disruption of certain medical devices and IVDs.
The measures will also speed the rollout of EUDAMED, making several of its modules mandatory beginning in 2026. Prior to the amendment, EUDAMED compliance would only become mandatory once all six of its modules are in place; however, once the amended regulations take effect,
“This will increase transparency in the EU and provide an overview of medical devices available on the European market,” the Commission said.
To continue reading this article please go to RAPS .