Signify Premium Insight: MDR Postponement: Impact on EHR and Drug CDS Product Roadmap

It was the news that medical device manufacturers were expecting, but the EU Commission has published a draft amending act (‘Proposal’) pushing back the Medical Devices Regulation (MDR) deadline for re-certifying medical devices. The deadline for recertifying Class IIa and Class I devices would shift from May 2024 to May 2028, a change which would have consequences for drug clinical decision support (CDS) and EHR vendors in the bloc. 

The EU’s rationale for the extension is simple. With increasingly rigorous MDR safety standards imposed on devices, there is a huge backlog of re-certifications of products originally certified under the Medical Devices Directive (MDD) regime. This delay is causing a shortage of MDR-compliant devices on the market, including drug CDSs, with clear implications for patient safety.