CE marking indicates that a product, including a medical device, conforms to the applicable EU legislation and can be placed on the European market. For medical devices this means meeting the general safety and performance requirements of the MDR or IVDR. For all but the lowest risk devices, a manufacturer cannot self-certify. Instead an independent conformity assessment body, called a notified body, reviews the technical documentation, quality management system, and clinical or performance evidence before the device may carry the CE mark. Notified bodies are designated and monitored by national authorities under EU oversight. The number of designated notified bodies and their available capacity has been a central constraint in implementing the MDR and IVDR, directly affecting how quickly devices can be certified and reach patients.
What is CE marking?
CE marking is the conformity marking that shows a medical device meets EU legal requirements; notified bodies are the independent organisations that assess conformity.
Can manufacturers self-certify medical devices?
Only the lowest risk devices can be self-certified. Most devices require assessment by a notified body before they can carry the CE mark and be placed on the EU market.
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