What are the MDR and IVDR regulations, and why do they matter?

The MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are the EU’s rulebooks for making sure medical devices — like hip replacements, pacemakers, and blood test kits — are safe and effective before they reach patients. Think of them as the EU version of food safety standards, but for medical devices, instruments and tests. They define what manufacturers must prove, and provide requirements for the organisations that confirm their work. These organisations are called Notified Bodies.