CE Mark Definition
CE marking involves awarding a firm/organization a certification mark to indicate that there is conformity with environmental protection, health, and safety standards for traded products within the European Economic Area (EEA). CE marking is also applicable to other countries outside the EEA which are manufactured, designed, or sold in the EEA. As a result, CE marketing has been recognized across the globe even among people who are not familiar with EEA. The regulation is used in similar sense as the FCC Declaration of Conformity in the US which restricts certain electronic devices.
A Little More on What is a CE Mark
CE marking is the declaration of a manufacturer that the products manufactured or sold are meeting the EC directives requirements. A CE logo characterizes the mark with four-digit identification number of the Notified Body that conducted the conformity assessment.
Originated in 1985, “CE” is the abbreviation of Conformité Européenne, which means European Conformity. However, CE has not been defined as the abbreviated teem in the relevant legislation. The mark is the free marketability symbol in the European Economic Area.
Countries that require CE marking
CE marking is a mandatory process for all product manufacturers or sellers within the EAA, which includes 28 member states of the European Union and EFTA countries such as Iceland, Liechtenstein, and Norway as well as Switzerland and Turkey. Other groups to comply with CE marking include importers of goods from other countries.
As of 2013, CE marking was not a mandatory requirement for member states of the Central European Free Trade Agreement (CEFTA). The members included were Serbia, the Republic of Macedonia, and Montenegro which has applied for the EU membership and were adopting several standards within the CEFTA legislations.
Rules underlying CE marking
The role of CE marking lies with the parties or companies that put products in the EU market, i.e., manufacturers based in the EU, importers, and distributors of products outside the EU, and non-EU manufacturers whose offices are based in the EU.
Although product manufacturers affix the CE marking on products, there are certain obligatory steps that must be taken. The manufacturer must go through a conformity assessment which entails setting up a technical file and signing a Declaration that is stipulated by the leading product legislation. The documentation is made available to CE marking authorities upon request.
Product imports must also verify that the non-EU manufacturer has undertaken the necessary steps and that documentation will be available upon request. The law also requires importers to ensure that contact with the manufacturer can easily be established.
Also, distributors should be able to demonstrate that they have taken the necessary steps in line with CE marking regulations and must have affirmation from the importer or manufacturer that all the legal requirements have been met.
In case importers and distributors are marketing products under their name, it means that they have undertaken the responsibility of the manufacturer. In such a situation, they need to have sufficient information on the production and design of the product since they are taking legal responsibility when affixing CE marking.
The key rules that underlie the procedure of affixing CE marking include:
- Products that are subject to EU regulations or directives have to be affixed with CE marking before taken to the market.
- It is mandatory for manufacturers to check which EU legislation is needed to apply for a particular product.
- A product may be placed in the market only when it complies with the applicable regulations and only after undertaking the conformity assessment procedure.
- It is the responsibility of the manufacturer to draw up EU conformity declaration or performance declaration and affixes the CE marking on the promoted products.
- EU directives and regulations stipulate that any authorized third party must be involved in the procedure of conformity assessment or in setting up a production quality system.
- If a product has been affixed with CE marking, it can bear additional markings if they have different significance. It is required that the markings do overlap with the CE marking so as not to impair the visibility and legibility of the CE marking.
The first guide intended to provide a clear CE marking directive based on the Global Approach was published in 2000 by the EU. The version was updated on 2014 February and 2016 July.
References for CE Mark
Academic Research for CE Mark
- Europeans are left to their own devices, Cohen, D., & Billingsley, M. (2011). Bmj, 342, d2748. This paper discusses the regulatory framework in the EU that is used to approve goods before they are accepted in the market. The authors highlight that there are currently 76 notified regulatory bodies in Europe and 6 in the UK including Intertek, SGS, and BSI. Manufacturers are expected to report to these bodies to ensure that their product comply with CE marking directives. In particular, CE making has been discussed extensively including its definition and all the processes to be followed to suffix the marking on a particular product. In addition, the paper discusses the European standards that are specific to medical devices including the EN 13485 and the UKAS (United Kingdom Accreditation Service).
- Health technology assessment of medical devices: what is different? An overview of three European projects, Schnell-Inderst, P., Mayer, J., Lauterberg, J., Hunger, T., Arvandi, M., Conrads-Frank, A., … & Siebert, U. (2015). Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen, 109(4-5), 309-318. This article provides a health technology assessment of medical devices in Europe. The authors assert that there is a growing significance of health technology assessment (HTA) in decision making. However, shareholders and decision makers face challenges because of the specific characteristics of health technologies such as diagnostic screening, pharmaceuticals, and screening programs, regulation processes, and their developmental environment. Understanding the need of HTA as a legislative instrument for sustainable health care system in a decentralized CE marking system is very crucial. Using such regulations has enabled the EU to support the development of medical devices assessment methods at different levels.
- Patient access to medical devices—a comparison of US and European review processes, Basu, S., & Hassenplug, J. C. (2012). New England Journal of Medicine, 367(6), 485-488. This paper reviews the difference in the patient access to medical devices in the US and Europe. The author provides an overview of the approval process of innovative, risk medical devices in both countries. It is argued that the Food and Drug Administration (FDA) should lower its approval standards as this is delaying the country’s access to lifesaving innovative technology. Studies suggest that the country should take similar period to allow patients to gain access to innovative, and high-risk medical devices just like it is observed in European countries like Germany, Italy, France, and Britain. Criteria considered to make the comparisons include the level of device innovation, start and end points, and patient access at the time of reimbursement.
- Medical device development: US and EU differences, Sorrel, S. (2006). Applied Clinical Trials, 15(8), 54. This article discusses the difference in the medical device development in both the US and the EU, highlighting the existing differences. It is highlighted that the way in which devices are regulated in the EU is different form the way they are regulated in the US. This difference, according to the author, has resulted in huge differences in time-to-market approval in the two countries, particularly in regard to high-risk Class III and Class IIb. As such, the US always experience a delay of between one to three years in accessing specific technical innovations like drug eluting stents compared to their European counterparts.
- What is CE marking? How technologies are classified, and how to navigate the system, Grimes, R. T., Bennett, K., & Henman, M. (2015). Value in Health, 18, A335-A766. This study attempts to understand the concept CE marking as well as its influence in the classification of technologies. The main objective is to clarify the process of affixing a CE mark understanding of how product manufacturers affix a CE mark and meet all the necessary legal requirements and conforming to relevant product safety directives in the European Union. According to the authors, CE marking is a mandatory process, but applies only to products which are covered by the New Approach Directives. The authors have used published reviews to clarify the process through which a CE mark can be obtained. The findings have revealed that medical devices are categorized into 3 groups depending on the different EU directives: Medical Device Directive, Active Implantable Medical Devices Directive, and in Vitro Diagnostic Medical Devices Directive.
- Strategy for adopting European norms and CE marking for export of Indian products, Das, S. K. (1997, December). In Electromagnetic Interference and Compatibility’97. Proceedings of the International Conference on (pp. 181-187). IEEE. This paper describes how EN standards and CE marking procedures are applied in the real world. The authors provide a brief idea of the costs associated with EMC measurement facility in the Indian market. Further they provide an analysis of the role of SAMEER-Centre for Electromagnetics in regard to Indian products export.
- The impact of CE marking on the competitiveness of enterprises, KANJEvAC, K., Arrsovski, S., Kokić Arsić, A., Pavlović, A., & Ćurčić, S. (2011). Strojarstvo, 53(6), 445-453. This article provides an overview of the impact of CE marking on the competitiveness of enterprises. The authors assert that majority of products promoted or sold in Europe must comply to CE marking. Every manufacturer is expected to mark his/her product as a declaration of complying with the European technical regulations related to the region’s health, safety, and environment protection legislation. As such, the authors reveal the current level of safety, quality, and competitiveness of products that have obtained CE markings. Thus, simulation solutions have been presented with dominant impact on competitiveness.
- CE Marking–the Essential Requirements, Playle, M. (2011). In Advances in systems safety (pp. 251-271). Springer, London. This paper discusses the role of CE marking on product quality and safety as well as the essential requirements of CE marking. According to the authors, the European Union harmonization project introduced the concept of CE marking to allow for free shipment and sales of products across the European market. CE marking replaced the mid-1990s EC mark and its fundamental New Approach Directives. The marking directive requires that products comply with certain goal setting essential requirement. Manufacturers may satisfy such requirements through the application of European harmonized standards, although it is not mandatory.
- Meeting the product safety requirements for CE marking in the European Union, Clements, V. C. (1997, August). In Electromagnetic Compatibility, 1997. IEEE 1997 International Symposium on (pp. 8-13). IEEE. This paper discusses the product safety requirements for CE marking in the European Union. According to the author, the implementation of the Machinery and Low Voltage product safety directives which has caused confusion in regard to how compliance is demonstrated. This paper, thus, aims to address the confusion issue and provide clarification.
- Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts, Heneghan, C., Thompson, M., Billingsley, M., & Cohen, D. (2011). BMJ open, bmjopen-2011. This study provides an overview of the safety notices and alerts associated with medical-device recalls and the device-regulation process in the UK. The authors elaborate that medical devices are widely subjected to regulations yet their clinical requirements, impact on patient safety, and number of recalls are poorly understood. They have utilized publicly available information on the Medicines and Health Regulatory Authority website and European directives to review existing Medical Device alerts.