European Union| Regulatory Market Profile

European Union medical device regulatory profile

Updated January 6, 2023

EU Medical Device Regulatory Agencies

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

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Annex VIII, Chapter III of MDR

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MDCG 2021-24 - Guidance on classification of medical devices

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

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Annex VIII of the IVDR - Classification rules

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MDCG 2020-16 Rev.1 - Guidance on classification rules for IVDs

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.

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768/2008/EC - Common framework for the marketing of products

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EU CE marking overview

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.

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Conformity Assessment

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Nando database of notified bodies

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Medical Devices

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In Vitro Diagnostic Devices

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Implantable Medical Devices

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Technical documentation and 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.

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EU MDR Chapter VII - Section 2

Post-Market Vigilance

Post-market vigilance requirements call for manufacturers to report any serious incident involving a marketed device, along with all field safety corrective actions that are made.

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EU MDR Article 87 - Reporting of serious incidents and field safety corrective actions

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.

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EC Unique Device Identifier (UDI) information

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MDCG 2021 1 Rev 1
Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional.

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MDCG 2022-12
Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional - for In Vitro diagnostic devices.

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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Summary of harmonized standards in EU 2017/745