MDR and IVDR corrigenda set for approval
The European Parliament’s (EP’s) Committee on the Environment, Public Health and Food Safety (ENVI) voted in favor of the second corrigenda amending the Medical Devices Regulation (MDR) and the In Vitro Medical Devices Regulation (IVDR) on 3 December 2019. The texts are likely to become effective by the end of the year, after they are approved by the EP’s plenary and published in the EU Official Journal.
The MDR corrigendum notably introduces a new measure that grants four more years to manufacturers to ensure compliance with the MDR for up-classified medical devices. This extends the deadline until May 2024 for class I reprocessable devices that must be certified by a Notified Body under MDR, but not under the Medical Devices Directive (MDD).
The IVDR corrigendum introduces, among other changes, a clarification that tests designed to determine feto-maternal blood group incompatibility are not automatically classed as high risk or class D when intended to determine any of the markers defined in Annex VIII rule 2, but could also be classed as moderate-risk class C products. While both class C and D products require conformity assessment by a Notified Body, higher compliance requirements are imposed on manufacturers for class D devices, including testing by an EU Reference Laboratory or assessment by an independent expert panel if no applicable Common Specifications exist.
SFL has extensive experience in all aspects of medical devices and IVDs, and has a dedicated Combination Products team. We would be happy to discuss your projects and how SFL can support you with your products and MDR-implementation activities from strategic advice on development, manufacturing, clinical evaluation and quality management system, to CE-marking and post-marketing maintenance.