The Medical Device Regulation, Regulation (EU) 2017/745, is the primary law governing medical devices in the European Union. It applied from 26 May 2021, replacing the earlier Medical Device Directive and Active Implantable Medical Device Directive. The MDR tightened requirements across the board: stricter clinical evidence, reclassification of many devices into higher risk classes, expanded roles for notified bodies, unique device identification, and a central database called EUDAMED. Manufacturers must demonstrate conformity through clinical evaluation and post-market surveillance, and appoint a person responsible for regulatory compliance. Software with a medical purpose falls within scope and is classified according to the harm its information can cause. Transitional provisions have been extended several times to ease notified body capacity constraints, so the effective dates for legacy devices depend on their risk class and certificate status.
What is the EU MDR?
The EU Medical Device Regulation (EU) 2017/745, the framework governing the safety and market access of medical devices in the European Union.
When did the MDR come into force?
The MDR entered into application on 26 May 2021, after a transition from the previous Medical Device Directive. Extended transitional deadlines apply to certain legacy devices depending on their risk class.
What is the difference between the MDR and IVDR?
The MDR covers general medical devices, while the IVDR, Regulation (EU) 2017/746, covers in vitro diagnostic devices such as tests and assays. They are parallel regulations with similar structures but different classification rules.
New European regulations updating rules for medical devices enter into force
New European regulations updating medical device rules enter into force on 19 July 2026.
Portugal INFARMED · Portugalswissdamed: Mandatory registration of medical devices and in vitro diagnostic medical devices as of 1 July 2026
Mandatory registration of medical devices and in vitro diagnostic medical devices in the Swiss registry (swissdamed) enters into force.
Swissmedic · SwitzerlandPublished amendments to the regulation on medical devices
Commission Delegated Regulation (EU) 2026/1451 amending Regulation (EU) 2017/745 on medical devices enters into force on 19 July 2026, expanding requirements for implantable and Class III devices.
Latvia ZVA (State Agency of Medicines) · LatviaMDCG Opinion 2026-5 on UDI assignment between manufacturers and distributors
Publication of MDCG guidance on the allocation of unique device identification (UDI) responsibilities between manufacturers and distributors.
Czechia SUKL · Czech RepublicBulletin on Medical Devices. April–June 2026
Bulletin implementing EU Regulation 2026/977 establishing uniform quality management and conformity assessment procedure requirements for medical devices.
AEMPS (Spanish Medicine Agency) · SpainGuidance: Ambient voice technology-enabled products
Guidance on device qualification and classification of ambient voice technology-enabled products as medical devices in Great Britain.
UK MHRA · UKMHRA clarifies regulatory status of ambient voice technologies used in the NHS
MHRA guidance clarifies how medical device law applies to ambient voice technology products in UK health and care settings.
UK MHRA · UKRegulatory Alignment for Predictable and Immediate Device Coverage Pathway (CMS-3487-NC) Procedural Notice Inviting Comment
CMS proposes a faster pathway for manufacturers to obtain Medicare coverage of new medical devices.
US CMS Newsroom · United States