European Union| Regulatory Market Profile
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Updated January 6, 2023
EU Medical Device Regulations & Guidance
EU Medical Device Classifications
Medical Devices
The EU uses a series of 22 rules that are to be evaluated in order to determine the classification of a medical device.
There are seven medical device classifications:
Note that the three sub-classifications within Class I have a slightly higher perceived risk than Class I and do require the involvement of a notified body before the manufacturer can affix the CE marking.
Class I - Lowest risk classification
Examples: Wheelchairs, reading glasses
Class IIa - Medium risk device
Examples: surgical clamp, dental fillings
Class Is - Device which much be presented sterile
Class IIb - Medium-to-high risk device
Examples: ventilators, bone fixation plate
Class Im - Device with a measuring feature
Class III - Highest risk device
Examples: heart valve, defibrillator
Class Ir - Device which is a reusable surgical instrument
In Vitro Diagnostic Devices
The EU uses a series of 7 classification rules for IVDs.
There are four IVD classifications:
Class A - Lowest risk classification
Examples: specimen receptacles and buffer solutions
Class C - IVDs used for detecting an infectious agent that does not have a high risk of propagation
Class B - IVDs for self-testing with lower risk to patients
Examples: pregnancy tests and cholesterol tests
Class D - IVDs that detect or are exposed to life-threatening transmissible agents or transmissible agents and infectious diseases with a high risk of propagation
Medical Device Market Requirements in the EU
CE Mark
The CE mark is the manufacturer’s claim that a device meets the General Safety and Performance Requirements (GSPR) of all relevant regulations in the MDR or IVDR. Items below are required to receive a CE mark.
Required to receive CE Mark:
Independent assessment by a notified body (NB) - most Class II, Class III, and In Vitro diagnostic devices require a conformity assessment by an NB.
Ensure conformance with applicable standards.
Compile required technical documentation.
Draft and sign an EU declaration of conformity.
EU Post-Market Requirements for Medical Devices
Post-Market Surveillance
All medical devices marketed in the EU require some level of post-market surveillance to monitor the performance of the device and to collect and analyze use-data.
The specific requirements of post-market surveillance (PMS) systems vary based on the risk level of the device, but it is always integrated with the quality management system.
Post-market surveillance systems are primarily proactive and designed to identify potential areas of improvement and concerning trends affecting the quality, performance, and safety of the device.
European Union UDI Requirements
UDI Compliance
UDI compliance deadlines have been delayed in the European Union. Compliance dates for labeling are spread out from May, 2022 (Class III devices) through May, 2027 (Class I reusable and Class A IVDs).
EUDAMED (European database on medical devices) registration is not being mandated until all 6 database modules are fully functional. Mandatory compliance for UDI data entry into the EUDAMED UDI module is estimated to be Q2, 2029.
Standards and Essential Requirements in the EU
The European Commission has published a list of harmonized standards which should be used to meet the general safety and performance requirements detailed in Annex 1 of both the MDR and IVDR. We list major standards here, but you should refer to the current list for complete and updated information.
EN ISO 13485: 2016: Quality Management Systems
EN ISO 14971: 2019: Risk Management
EN IEC 60601-2-83: 2020: Medical electrical equipment - basic safety and essential performance
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