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EU Standards

 

About European Union Standards

European Union Standards are critical regulations that ensure the safety, quality, and interoperability of products and services within the EU. These Standards are developed through a collaborative process involving representatives from EU member states and are designed to facilitate the smooth operation of the single market. By harmonizing requirements across different sectors such as electronics, health care, environmental protection, and consumer goods, EU Standards help eliminate trade barriers and promote innovation and competitiveness within and outside the EU.


Intertek Inform: Your Gateway to European Union Standards

Intertek Inform is your essential resource for navigating and adhering to European Union Standards. Our platform provides direct access to these Standards, enabling businesses to easily integrate them into their operations. Whether you need the latest Standards in digital or print format, Intertek Inform ensures that your business remains compliant and competitive in the European market. Our services help simplify the complexities of EU regulations, providing a clear path to certification and market access.

EU MDCG 2022-9 Rev.1:2024
Summary of safety and performance Template
EU MDCG 2024-5:2024
Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
EU MDCG 2024-4:2024
Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
EU MDCG 2024-3:2024
Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices
EU MDCG 2024-1:2024
Device Specific Vigilance Guidance (DSVG) Template
EU MDCG 2024-2:2024
Procedures for the updates of the European Medical Device Nomenclature
EU MDCG 2024-1-2:2024
Guidance on the vigilance system for CE-marked devices DSVG 02 Coronary Stents and associated delivery systems
EU MDCG 2024-1-1:2024
Guidance on the vigilance system for CE-marked devices DSVG 01 Devices for Cardiac Ablation
EU MDCG 2019-7:2023
Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)
EU MDCG 2023-6:2023
Guidance on demonstration of equivalence for Annex XVI products A guide for manufacturers and notified bodies
EU MDCG 2022-11:2023
MDCG Position Paper Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements
Regulation (EU) 2017/745:2023
Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices
EU MDCG 2022-9 Rev.1:2024
Summary of safety and performance Template
EU MDCG 2024-5:2024
guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
EU MDCG 2024-4:2024
Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
EU MDCG 2024-3:2024
Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices
EU MDCG 2024-1:2024
Device Specific Vigilance Guidance (DSVG) Template
EU MDCG 2024-1-2:2024
Guidance on the vigilance system for CE-marked devices DSVG 02 Coronary Stents and associated delivery systems
EU MDCG 2024-1-3:2024
Guidance on the vigilance system for CE-marked devices DSVG 03 Cardiac Implantable Electronic Devices (CIEDs)
EU MDCG 2019-7:2023
Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)
EU MDCG 2023-6:2023
Guidance on demonstration of equivalence for Annex XVI products A guide for manufacturers and notified bodies
EU MDCG 2023-5:2023
Guidance on qualification and classification of Annex XVI products A guide for manufacturers and notified bodies
EU MDCG 2022-11:2023
MDCG Position Paper Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements
EU MDCG 2023-4:2023
Medical Device Software (MDSW) - Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components

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Frequently Asked Questions

Read on to find out more on European Union Standards

European Union Standards are a set of harmonized regulations and guidelines established by the European Union to ensure product safety, quality, and compatibility across its member states. These standards are developed to facilitate free trade within the single market, promote high levels of consumer protection, and foster environmental sustainability.  

European Union Standards are used to ensure that products and services meet stringent requirements for safety, quality, and environmental impact before they are sold in the EU market. They are crucial for manufacturers, importers, and service providers who aim to trade within the EU, as compliance is often a prerequisite for market entry. Additionally, these standards serve as a benchmark for industries to innovate and improve their offerings while adhering to high regulatory standards.

European Union Standards are owned and maintained by the European Union itself, through its various bodies such as the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI). These organizations operate from Brussels, Belgium, and coordinate with national standards bodies from each EU member state to develop and uphold standards applicable throughout the EU.  

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