MDCG has published Revision 4 of MDCG 2020-16, updating the classification of in vitro diagnostic medical devices (IVDs) in accordance with IVDR Regulation (EU) 2017/746. Among the main changes is the reclassification of SARS-CoV-2 tests. In addition, adjustments have been made to the classification of blood, tissue and organ screening tests, as well as clarifications for complementary diagnostics and self-tests.

The MHRA has confirmed that four key EU regulations for the regulation of medical devices and in vitro diagnostic medical devices (IVDs) will be retained in the UK after May 26, 2025. The decision covers rules on common technical specifications, electronic instructions for medical devices, the use of tissues of animal origin and the supervision of approved bodies. In addition, the MHRA plans to update the legislation, replacing the reference to Regulation (EU) 207/2012 with the more recent Implementing Regulation (EU) 2021/2226. Meanwhile, further changes are expected with the upcoming "Pre-Market" legislation, which could impact the requirements for high-risk IVDs and remove temporary approvals for COVID-19 testing. Manufacturers and companies in the sector should follow these updates to ensure regulatory compliance in the UK market.

MDCG 2024-8 Revision 1 brings crucial updates for IVDR compliance, including streamlined processes for conformity assessment and updated guidelines for notified bodies. Stay informed about regulatory changes in in vitro diagnostic devices under Regulation (EU) 2017/746. Learn how Smart MDR can support your business with expert guidance on IVDR conformity, ensuring compliance with EU medical device regulations. From quality management systems to technical documentation, we help you navigate the complexities of regulatory frameworks with confidence.