CE stands for "Conformité Européenne," which translates to "European Conformity" in English. It is a mandatory conformity marking required for products sold within the European Economic Area (EEA), which includes the member states of the European Union (EU), as well as Iceland, Liechtenstein, and Norway.
The obligation of CE marking arises from EU legislation, which mandates that certain products meet specific health, safety, and environmental protection requirements before they can be placed on the market within the EEA. These requirements vary depending on the type of product and are outlined in relevant EU directives and regulations.
Manufacturers: Manufacturers play a pivotal role in ensuring product safety within the EEA market. Their responsibilities include conducting thorough assessments to ensure compliance, preparing technical documentation, issuing the EU declaration of conformity, and affixing the CE marking onto the product.
For manufacturers, the obligation of CE marking involves conducting a conformity assessment to demonstrate that their products comply with the applicable EU requirements. This typically includes:
- Identifying the relevant EU directives or regulations that apply to the product.
- Ensuring that the product meets the essential requirements set out in those directives or regulations.
- Carrying out conformity assessment procedures, which may involve testing, documentation, and quality control measures.
- Compiling a technical file containing all relevant information about the product's design, manufacturing process, and compliance with EU requirements.
- Issuing a declaration of conformity stating that the product meets the applicable EU standards.
- Affixing the CE marking to the product, packaging, or accompanying documentation to indicate compliance with EU regulations.
Importers and Distributors: Importers and distributors also have obligations related to CE marking. They must ensure that the products they place on the market comply with EU requirements and bear the CE marking where necessary. This includes verifying that manufacturers have fulfilled their obligations regarding conformity assessment and documentation.
EU Consumers: Consumers in the EU have diverse preferences when choosing products like laptops or toys for their children. However, regardless of their preferences, they expect all products on the market to prioritize safety. The presence of the CE marking provides assurance that the products meet the necessary safety standards. The obligation of CE marking is essential for ensuring the safety, health, and environmental protection of products sold within the EEA. It helps facilitate the free movement of goods within the internal market while maintaining high standards of quality and consumer protection. Compliance with CE marking requirements is therefore a fundamental aspect of accessing the European market for manufacturers, importers, and distributors alike.
EU Consumers: Consumers in the EU have diverse preferences when choosing products like laptops or toys for their children. However, regardless of their preferences, they expect all products on the market to prioritize safety. The presence of the CE marking provides assurance that the products meet the necessary safety standards. The obligation of CE marking is essential for ensuring the safety, health, and environmental protection of products sold within the EEA. It helps facilitate the free movement of goods within the internal market while maintaining high standards of quality and consumer protection. Compliance with CE marking requirements is therefore a fundamental aspect of accessing the European market for manufacturers, importers, and distributors alike.
Objective of CE Marking
- CE marking serves several crucial purposes. Firstly, it ensures that medical devices meet the rigorous safety and performance standards established by EU regulations. This is vital for safeguarding the health and well-being of patients and healthcare professionals who rely on these devices for diagnosis, treatment, and monitoring.
- CE marking facilitates the free movement of medical devices across the EEA market. By harmonizing regulatory requirements and standards, it eliminates barriers to trade within the region, allowing manufacturers to access a larger customer base and promoting market competitiveness.
- CE marking enhances transparency and accountability in the medical device industry. It signifies that manufacturers have conducted thorough conformity assessments, complied with applicable regulations, and documented their adherence to regulatory requirements. This transparency builds trust among consumers, healthcare providers, and regulatory authorities, fostering confidence in the safety and reliability of medical devices bearing the CE mark.
- European Union Institutions
- European Commission: The European Commission is the executive body of the EU responsible for proposing legislation, implementing decisions, and upholding EU treaties. It oversees various policy areas, including trade, industry, and consumer protection. European Parliament: The directly elected parliamentary institution of the EU, representing the citizens of the EU member states. It participates in the legislative process, including amending and adopting legislation proposed by the European Commission.
- Council of the European Union: Represents the governments of the EU member states and, together with the European Parliament, adopts EU laws and coordinates policies. It comprises ministers from each member state, with the composition varying depending on the policy area under discussion.
- European Council: Comprises the heads of state or government of the EU member states, along with the President of the European Council and the President of the European Commission. It sets the EU's overall political direction and priorities.
Legislative Process
- Proposal: The European Commission proposes legislation based on identified needs or policy objectives.
- Negotiation: The proposed legislation is reviewed and amended by the European Parliament and the Council of the European Union through a process of negotiation and compromise.
- Adoption: Once agreement is reached between the European Parliament and the Council, the legislation is adopted and becomes EU law.
- Transposition: EU directives require member states to transpose the legislation into their national laws within a specified timeframe.
Regulatory Agencies and Bodies
- European Medicines Agency (EMA): Responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU.
- European Chemicals Agency (ECHA): Manages the technical, scientific, and administrative aspects of the EU's chemicals legislation, including the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.
- European Aviation Safety Agency (EASA): Ensures the highest common level of aviation safety and environmental protection in the EU.
CE Marking Process
- Identification of Applicable Directives/Regulations: Manufacturers identify the relevant EU directives or regulations applicable to their products.
- Conformity Assessment: Manufacturers conduct a conformity assessment to demonstrate compliance with the essential requirements set out in the applicable directives or regulations.
- Technical Documentation: Manufacturers compile technical documentation containing all necessary information to demonstrate conformity.
- Declaration of Conformity: Manufacturers issue a declaration of conformity declaring that the product meets the applicable requirements.
- Affixing CE Marking: Upon successful completion of the conformity assessment, manufacturers affix the CE marking to the product, indicating compliance with EU regulations.
The Applicability of Directive and Regulation For CE Marking
| Aspect | Directives | Regulations |
|---|---|---|
| Legal Nature | Requires transposition into national law by member states. | Automatically applicable and enforceable in member states without the need for transposition. |
| Binding Force | Binding as to the result, but leaves member states the choice of form and methods. | Binding in its entirety and directly applicable in member states. |
| Flexibility | Allows member states flexibility in implementation, which may lead to variations in national laws. | Imposes uniform rules across all member states, ensuring harmonization. |
| Scope | Sets out general objectives and principles to be achieved by member states. | Specifies detailed rules and requirements applicable across all member states. |
| Timeframe for Adoption | Typically provides member states with a deadline for transposition into national law. | Becomes immediately applicable on the specified date without the need for transposition. |
| Examples | Medical Devices Directive (MDD), Machinery Directive, Low Voltage Directive. | General Data Protection Regulation (GDPR), REACH Regulation, Medical Devices Regulation (MDR). |
Table 1.: Difference Between Directive and Regulation
| Aspect | Directives | Regulations |
|---|---|---|
| Harmonization | Allows for some flexibility in interpretation and implementation by member states, leading to potential variations in enforcement. | Provides a more uniform and consistent framework across all member states, reducing discrepancies in interpretation and implementation. |
| Updates and Amendments | Amendments to directives may require a lengthy process of negotiation and transposition into national laws, leading to delays in addressing emerging issues. | Regulations can be updated and amended more efficiently by the European Commission, allowing for quicker adaptation to technological advancements and changing needs. |
| Legal Certainty | Directives may introduce legal uncertainties due to differences in interpretation and transposition among member states, potentially leading to compliance challenges. | Regulations offer greater legal certainty as they are directly applicable in member states without the need for transposition, providing clearer and more consistent rules. |
| Enforcement | Enforcement of directive requirements may vary among member states, leading to inconsistencies in market surveillance and product compliance. | Regulations facilitate more consistent enforcement across member states, ensuring a level playing field for businesses and greater protection for consumers. |
| Market Access | Compliance with directives may require separate conformity assessments and certifications for each member state, resulting in administrative burdens and barriers to market access. | Compliance with regulations allows for easier market access across all member states, as products meeting regulatory requirements can be sold throughout the EU without additional national certifications. |
Table 2.: Obligation Under Directive and Regulation
A Typical Procedure to Obtain CE Marking under Medical Device Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746)
In order to place medical devices and in vitro diagnostic medical devices on the European market, manufacturers must adhere to stringent regulatory requirements outlined in the Medical Device Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746). Obtaining CE marking is a crucial step in this process, as it signifies compliance with the essential safety and performance requirements set forth by these regulations. The journey to achieve CE marking involves a series of steps, including conformity assessment, compilation of technical documentation, and issuance of the Declaration of Conformity.Regulatory Agencies and Bodies Responsible
European Medicines Agency (EMA): The European Medicines Agency (EMA) serves as the prime authority responsible for implementing and introducing regulations governing medical devices and in vitro diagnostic medical devices within the European Union (EU). Under the EMA umbrella, each EU member country designates a Competent Authority tasked with overseeing regulatory compliance and enforcement at the national level. These Competent Authorities play a crucial role in evaluating and monitoring the safety, efficacy, and quality of medical devices placed on the market within their respective jurisdictions. They collaborate closely with the EMA to ensure harmonized regulatory practices and adherence to EU regulations across all member states.| Notified Bodies | Organizations designated by EU Member States to assess conformity of certain products with EU legislation |
| Authorized Representative (AR) | Appointed by manufacturers located outside the EU to act as their legal representative within the EU |
| Manufacturer | Entity responsible for designing, producing, and placing medical devices or IVDs on the market in the EU |
| Importer/Distributor | Responsible for ensuring that only compliant products bearing CE marking are placed on the market in the EU |
| Economic Operator | Roles and Responsibility | Reporting To |
|---|---|---|
| Notified Bodies | Conduct conformity assessments and issue CE certificates for medical devices and in vitro diagnostic medical devices. They evaluate product compliance with relevant regulations and standards. | Competent Authorities (CA) and European Database on Medical Devices (EUDAMED) |
| Authorized Representative | Acts on behalf of the manufacturer based outside the EU, ensuring compliance with regulatory requirements and representing the manufacturer in communication with authorities. | Manufacturer |
| Manufacturer | Responsible for designing, manufacturing, and placing medical devices or in vitro diagnostic medical devices on the market in compliance with applicable regulations. Must conduct conformity assessment, compile technical documentation, and issue Declaration of Conformity. | Competent Authorities (CA), Notified Bodies, and Authorized Representative (if applicable) |
| Importer/Distributor | Responsible for ensuring that medical devices or in vitro diagnostic medical devices they place on the market comply with relevant regulations. Must verify CE marking, maintain records, and cooperate with authorities if issues arise. | Competent Authorities (CA) and Manufacturer |
Table 3.: Economic operators and their obligations
CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.
How to obtain CE marking?
- Ensure Conformity with EU-wide Requirements: As the manufacturer, it's your responsibility to ensure that your product meets all relevant requirements set forth by EU regulations. These requirements typically cover aspects such as safety, performance, and environmental protection.
- Determine the Need for Involving a Notified Body: Depending on the classification of your product and the applicable regulations, you may need to involve a notified body for conformity assessment. Notified bodies are independent organizations designated by EU Member States to assess whether products meet specific requirements.
- Compile Technical Documentation: You'll need to prepare a technical dossier that documents how your product conforms to the applicable requirements. This documentation should include details about the design, manufacturing process, performance testing, and any risk assessments conducted.
- Draft and Sign an EU Declaration of Conformity: The EU Declaration of Conformity is a formal document in which you declare that your product complies with all relevant EU regulations. This document must be signed by a responsible individual within your organization and should accompany the product when it is placed on the market.
- Provide Information to Competent Authorities: If requested by the competent national authority, you must be prepared to provide them with all relevant information and documentation related to the CE marking of your product. This may include the technical dossier, test reports, and the EU Declaration of Conformity.
Select the Notified Body here;
Mandatory Obligation under Medical Device Regulation and In-Vitro Diagnostic Regulation
- Implementation of EN ISO 13485: Manufacturers must implement and adhere to the requirements of the EN ISO 13485 standard, which specifies the quality management system (QMS) for medical device manufacturers. Compliance with ISO 13485 ensures the establishment and maintenance of an effective QMS to meet regulatory requirements and maintain product quality and safety.
- Test Reports Against Applicable Standards: Manufacturers must conduct and provide test reports demonstrating compliance with applicable standards for their medical devices or in-vitro diagnostic devices. These test reports serve as evidence of conformity and ensure that the products meet the required safety, performance, and quality standards specified by regulatory authorities. The test reports must be from NABL accredited laboratory and having ILAC agreement in place to be accepted in EU union without any question.
- Appointment of Authorized Representative: Manufacturers located outside the EU must appoint an Authorized Representative within the EU. The Authorized Representative acts on behalf of the manufacturer and ensures compliance with regulatory requirements within the EU market.
- EUDAMED Registration: Manufacturers are required to register certain information and data related to their medical devices or in-vitro diagnostic devices in the European Databank on Medical Devices (EUDAMED). This includes details about the device, manufacturer, Authorized Representative, conformity assessment, and post-market surveillance.
- UDI (Unique Device Identification) Requirements: Medical devices and in-vitro diagnostic devices must bear a Unique Device Identifier (UDI) as per the regulations. The UDI includes a Device Identifier (DI) and, in some cases, a Production Identifier (PI). Manufacturers are responsible for assigning and labeling their products with the appropriate UDIs.
Conformity Assessment Procedures
Conformity Assessment Procedures under the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) are crucial steps to ensure that medical devices and in-vitro diagnostic devices comply with the regulatory requirements before they can be placed on the market. These procedures determine whether the products meet the essential safety and performance requirements as outlined in the regulations.
What conformity assessment is
- A product undergoes a conformity assessment before it is placed on the market
- It needs to demonstrate that it meets all legislative requirements
- It includes testing, inspection and certification
- The applicable product legislation specifies the procedure for each product
Objectives of the conformity assessment procedure
- To demonstrate that a product being placed on the market complies with all legislative requirements.
- The procedure should ensure confidence of consumers, public authorities and manufacturers regarding the conformity of products.
How does it work in practice?
- Product legislation describes the conformity assessment procedures for each product.
- Manufacturers may choose between different conformity assessment procedures, if applicable.
- The manufacturer carries out the assessment. The conformity assessment process involves a conformity assessment body if required by the applicable legislation – see notified bodies
Annex IX - MDR & IVDR
Annex IX of the Medical Device Regulation (MDR) 2017/745 and the In-Vitro Diagnostic Regulation (IVDR) 2017/746: outlines the conformity assessment procedure based on a quality management system (QMS) and assessment of the technical documentation. This annex specifies the requirements for manufacturers to demonstrate conformity with the essential requirements of the regulations by establishing and maintaining a robust QMS.Key aspects of this conformity assessment procedure include:
Quality Management System (QMS):
- Manufacturers must establish, implement, and maintain a QMS that conforms to the relevant harmonized standards, such as EN ISO 13485.
- The QMS should cover all aspects of device design, development, manufacturing, distribution, and post-market surveillance to ensure compliance with regulatory requirements and the safety and performance of the devices.
- Manufacturers are required to prepare comprehensive technical documentation that demonstrates conformity with the essential requirements of the regulations.
- Technical documentation should include information on device design, specifications, manufacturing processes, risk management, clinical evaluation, and post-market surveillance activities.
- The documentation should be regularly updated and maintained throughout the device lifecycle to reflect any changes or updates.
- Conformity assessment under Annex IX is based on the evaluation of the manufacturer's QMS and technical documentation by a Notified Body (NB) or, for certain low-risk devices, by the manufacturer themselves.
- The NB assesses the manufacturer's QMS to ensure it meets the requirements of the regulations and verifies the completeness and adequacy of the technical documentation.
- Manufacturers must demonstrate that their QMS effectively controls all aspects of device manufacturing and ensures consistent compliance with regulatory requirements.
- Upon successful assessment, the NB issues a certificate of conformity, indicating that the manufacturer's QMS and technical documentation meet the requirements of the regulations.
- Manufacturers use the certificate of conformity to support their Declaration of Conformity, affirming that their devices comply with the essential requirements of the MDR or IVDR.
- The Declaration of Conformity allows manufacturers to affix the CE marking to their devices, demonstrating compliance with EU regulatory requirements and enabling market access within the European Economic Area (EEA).
Annex X - MDR & IVDR
Annex X of the Medical Device Regulation (MDR) 2017/745 and the In-Vitro Diagnostic Regulation (IVDR) 2017/746 outlines the conformity assessment procedure based on type examination. This annex specifies the requirements for manufacturers to demonstrate conformity with the essential requirements of the regulations by submitting their devices to a Notified Body (NB) for examination of the device type.Key aspects of this conformity assessment procedure include:
Type Examination:
- Manufacturers submit their devices to a Notified Body (NB) for examination to verify conformity with the essential requirements of the regulations.
- The NB assesses the technical design and specifications of the device, as well as any relevant documentation provided by the manufacturer.
- The type examination focuses on verifying compliance with specific requirements, such as safety, performance, and intended purpose, as outlined in the regulations.
- The NB evaluates the device against predefined criteria established in the regulations and relevant harmonized standards.
- The examination may include testing of device samples, review of technical documentation, and assessment of the manufacturing process to ensure consistency and compliance.
- Manufacturers must provide comprehensive technical documentation to support the type examination process.
- The documentation should include detailed information on device design, specifications, manufacturing processes, risk management, and performance testing results.
- Upon successful completion of the type examination, the NB issues a certificate of conformity, confirming that the device type meets the requirements of the regulations.
- Manufacturers use the certificate of conformity to support their Declaration of Conformity, affirming that all devices of the same type comply with the essential requirements of the MDR or IVDR.
- The Declaration of Conformity enables manufacturers to affix the CE marking to their devices, indicating compliance with EU regulatory requirements and facilitating market access within the European Economic Area (EEA).
Annex XI - MDR
Product Conformity Verification:
- Manufacturers are responsible for conducting conformity assessment activities to verify the conformity of their devices with the essential requirements of the MDR.
- This may involve testing, inspection, and evaluation of the device to ensure compliance with applicable regulatory requirements, including safety, performance, and quality standards.
- Manufacturers must compile and maintain comprehensive technical documentation that demonstrates conformity with the essential requirements.
- The technical documentation should include detailed information on device design, specifications, manufacturing processes, risk management, and performance testing results.
- Manufacturers must ensure that the conformity assessment activities are conducted in accordance with relevant harmonized standards, guidelines, and regulatory requirements.
- The assessment criteria may include specific test methods, acceptance criteria, and performance specifications established in the regulations or applicable standards.
- Based on the results of the product conformity verification process, manufacturers issue a Declaration of Conformity affirming that the device meets the essential requirements of the MDR.
- The Declaration of Conformity enables manufacturers to affix the CE marking to their devices, indicating compliance with EU regulatory requirements and facilitating market access within the European Economic Area (EEA).
Annex XI - IVDR
Key aspects of this conformity assessment procedure include:
Production Quality Assurance (PQA):
- Manufacturers are required to establish and maintain a comprehensive quality management system (QMS) that covers all aspects of device design, development, manufacturing, and post-market surveillance.
- The QMS should be designed to ensure consistent compliance with the essential requirements of the IVDR and to facilitate continuous improvement of product quality and safety.
- Manufacturers must develop and maintain technical documentation that provides evidence of conformity with the essential requirements of the IVDR.
- The technical documentation should include detailed information on device design, specifications, manufacturing processes, risk management, and performance evaluation studies.
- Manufacturers are responsible for implementing effective production controls to ensure that devices are manufactured in accordance with approved specifications and quality standards.
- This may involve establishing procedures for equipment calibration, process validation, product testing, and quality assurance inspections throughout the manufacturing process.
- Competent authorities may conduct audits of manufacturers' quality management systems to verify compliance with regulatory requirements.
- Manufacturers should be prepared to demonstrate the effectiveness of their QMS and provide evidence of ongoing compliance with the IVDR.
- Based on the successful implementation of production quality assurance measures, manufacturers issue a Declaration of Conformity affirming that the devices meet the essential requirements of the IVDR.
- The Declaration of Conformity enables manufacturers to affix the CE marking to their devices, indicating compliance with EU regulatory requirements and facilitating market access within the European Economic Area (EEA).
| Aspect | Annex IX | Annex X | Annex XI |
|---|---|---|---|
| Description | - Conformity assessment based on a quality management system (QMS) and assessment of the technical documentation | - Conformity assessment based on type examination | - Conformity assessment based on production quality assurance |
| Purpose | To demonstrate conformity with the essential requirements of the Regulation through implementation of a robust QMS and thorough technical documentation review | To verify conformity with specific design features and essential requirements through type examination and testing | To ensure ongoing compliance with regulatory requirements through implementation of production quality assurance measures |
| Applicability Criteria | - High and moderate-risk devices | - High and moderate-risk devices | - Low and moderate-risk devices |
| Requirements | - Implementation of a comprehensive QMS covering all aspects of device design, development, and manufacturing - Technical documentation review by notified body | - Type examination of representative samples - Verification of conformity with design and performance requirements | - Establishment and maintenance of a QMS ensuring consistent compliance with Regulation - Technical documentation to demonstrate conformity - Ongoing surveillance of production processes |
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