EU Medical Device Regulation (MDR)

What is the EU MDR?

Regulation (EU) 2017/745 replaced the Medical Device Directive and the Active Implantable Medical Devices Directive with a directly applicable EU regulation. It governs classification, conformity assessment through notified bodies, clinical evaluation, UDI, EUDAMED registration, economic-operator duties, post-market surveillance and vigilance across the device lifecycle. National law still matters for areas the regulation leaves to Member States, including penalties and some language requirements.

What changed compared with the MDD?

The MDR strengthened clinical-evidence and post-market clinical follow-up expectations, introduced new classification rules for technologies including software, added UDI and database obligations, defined duties for importers and distributors, required a Person Responsible for Regulatory Compliance, formalized post-market surveillance outputs and brought specified Annex XVI products without an intended medical purpose into its framework. The effect on a particular device depends on classification, intended purpose and transition eligibility rather than on one universal uplift.

What are the MDR transition deadlines?

The MDR has applied since 26 May 2021. Eligible legacy devices may use the extended transition in Article 120 until 31 December 2027 for Class III and most Class IIb implantable devices, or 31 December 2028 for other covered device groups. These dates are conditional, not blanket extensions. Among other requirements, the device must continue to comply with prior law, have no significant design or intended-purpose change, present no unacceptable risk, and have met the 2024 QMS, notified-body application and written-agreement deadlines. The applicable risk class for the transition is determined under MDR rules.

Does the MDR apply to non-EU manufacturers?

Yes, when they place covered devices on the EU market. A manufacturer without an establishment in a Member State must designate a sole EU authorized representative for at least all devices of the same generic device group, and its economic-operator, labeling and registration arrangements must meet the MDR. The European Union market page covers that sequence; EU case studies show how the mandate, registration and language work differ across real product families.