CE Marking

CE Compliance Certification

CE Compliance Certification is essential for manufacturers aiming to enter and thrive in the European market. To begin with, CE Certification demonstrates that a product meets the necessary EU safety, health, and environmental protection standards. Moreover, it ensures legal access to the European Economic Area (EEA), boosting market credibility. In addition, by obtaining CE Compliance Certification, businesses can reduce liability risks and enhance consumer trust. Furthermore, the certification process involves risk assessment, technical documentation, and conformity declarations. Ultimately, CE Certification not only facilitates smoother market entry but also reinforces product reliability and brand reputation across international markets.

  • CE MARKING;
  • CE TECHNICAL FILE PREPARATION SUPPORT
  • MDD TO MDR TRANSITION

Introduction to CE Marking

Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements. CE Certification is the documented process that verifies this compliance and allows the manufacturer to affix the CE mark. It is required for products manufactured anywhere in the world that are then marketed in the EU. CE Certification ensures that the product meets the essential requirements of relevant European directives and standards, enabling smooth entry and legal distribution within the European Economic Area.

What is CE Marking?

CE Marking shows that a product meets the essential safety, health, and environmental standards set by the European Union. The letters “CE” stand for Conformité Européenne, meaning European Conformity. To begin with, manufacturers must go through the CE Certification process, which involves testing, documentation, and a declaration of conformity. After completing these steps, they apply the CE Marking to their products. As a result, the product becomes eligible for sale across the European Economic Area (EEA). Through CE Certification, businesses ensure legal compliance, build customer trust, and gain access to one of the world’s largest markets.

Why CE Marking:

CE Marking plays a crucial role in accessing the European market. To start with, it proves that a product meets EU safety, health, and environmental standards. Next, through the CE Certification process, manufacturers demonstrate compliance with relevant directives. This not only ensures legal entry into the European Economic Area (EEA) but also builds trust with consumers and distributors. Moreover, CE Marking simplifies trade within EU member states by removing technical barriers. In the end, businesses that obtain CE Certification gain a competitive edge, reduce liability risks, and show their commitment to quality and regulatory compliance.

What benefits does it bring to the business?

 It is a mandatory requirement for the products exported to European countries.

  • Compliance with CE marking increases customer safety and low product liability risks.
  • Marking enhances product design.
  • Marking helps in creating a product and brand image.

CE Marking applies to the following products:

  1. Appliances Burning Gaseous Fuels
  2. Cableway Installations to Carry Persons
  3. Low Voltage Electrical Equipment
  4. Construction Products
  5. Equipment and Protective Systems for Use in Potentially Explosive Atmospheres
  6. Explosives for Civil Uses
  7. Hot Water Boilers
  8. Lift
  9. Machinery
  10. Measuring Instruments
  11. Medical Devices
  12. Active Implantable Medical Devices
  13. In Vitro Diagnostic Medical Devices
  14. Non-automatic Weighing Instruments
  15. Radio Equipment & Telecommunications Terminal Equipment
  16. Personal Protective Equipment
  17. Simple Pressure Vessels
  18. Pressure Equipment
  19. Recreational Craft
  20. Toys

Steps to achieve CE marking:

To achieve CE Marking, first identify applicable EU directives. Then, assess product conformity and perform required testing. Next, compile technical documentation and create a Declaration of Conformity. Finally, affix the CE mark to the product. Throughout the process, ensure compliance through CE Certification to meet EU regulatory requirements.

Step 1: Identify the applicable Directive(s)

The first step is to identify whether your product can be CE marked or not. Not all products are required to be CE Marked; only the products that fall within the scope of at least one of the CE Marking Directives. There are more than 20 product Directives & Regulations covering a range of products. Such products include (but are not limited to) electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices, and construction products.

Identifying which Legislation may be applicable involves a simple exercise of reading the scope of each Directive/Regulation. You then need to apply the scope to your product to establish which one applies.  (An example of the scope of the Low Voltage Directive below). Don’t forget that there may be more than one Directive/Regulation that applies to your product! Remember, if your product does not fall within the scope of any of the CE marking Directives, then your product does not need to be CE marked, but is likely to fall within the scope of other product Directives.

Step 2: Identify the applicable requirements of the Directive(s)

Each Directive has slightly different methods of demonstrating conformity. This usually depends on the classification of the product and its intended use. Every Directive has many ‘essential requirements’ which the product has to meet. The best way to demonstrate that these essential requirements have been met is by meeting the requirements of applicable ‘harmonised European Norms’ (Standard) known as hENs. Standards may offer a presumption of conformity to the essential requirements of the applicable Legislation. However, do not forget that the use of standards usually remains voluntary. HENS can be identified by searching the ‘official journal’ on the European Commission’s website.

Step 3: Identify an appropriate route to conformity

The CE Marking process is always a self-declaration process; however, you may need to involve a third party. This is set out in the ‘system of attestation’ and will vary between Directives. Some products (such as invasive medical devices or fire alarm systems) may, to some extent, have a mandatory requirement for some involvement of an authorised third party.

There are various attestation routes, which include:

  • An assessment of the product by the manufacturer.
  • An assessment of the product by the manufacturer, with additional requirements for mandatory factory production control audits to be carried out by a third party.
  • An assessment by a third party (e.g., EC type test), with the requirement for mandatory factory production control audits to be carried out by a third party.

Step 4: Assessment of the product’s conformity

When all of the requirements have been established, you need evidence that the product meets the essential requirements of the Directive(s). This usually involves some assessment and/or testing. It will often involve ensuring that the requirements of the applicable harmonised standard(s), which were identified in step 2, have been met.

Step 5: Compile the technical documentation

Technical documentation relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development, and manufacture of the product. Technical documentation may also be known as the Technical File or Technical Construction File.

Technical documentation will usually include:

  • Technical description.
  • Drawings, circuit diagrams, and photos.
  • Bill of materials.
  • Specification and, where applicable, Declarations of Conformity for the critical components and materials used.
  • Details of any design calculations.
  • Test reports and/or assessments.
  • Instructions.
  • Copy of the Declaration.

Documentation can be made available in any format (i.e., paper or electronic) and must be held for a period of up to 10 years after the manufacture of the last unit, and in most cases, reside in the European Economic Area (EEA).

Step 6: Make a Declaration and affix the CE Mark

When the manufacturer, importer, or authorised representative is satisfied that their product conforms to the applicable CE Marking Directives, they must complete a Declaration. Under most Directives, it is known as the EU Declaration of Conformity, but other terms exist. Such as the Declaration of Incorporation for partly completed machinery and the Declaration of Performance for construction products.

The requirements for the Declaration vary slightly, but will at least include:

  • Name and address of the manufacturer.
  • Details of the product (model, description, and the serial number, where applicable).
  • List of CE Marking Directives and standards that have been applied.
  • A statement declaring that the product complies with all of the relevant requirements.
  • Signature, name, and position of the responsible person.
  • The date that the Declaration was signed.
  • Details of the authorised representative within the EEA (where applicable).
  • Additional Directive/standard specific requirements.

In all cases, except for the PPE Directive, all of the Directives can be declared on one Declaration. Once a Declaration has been completed, the final step is to affix the CE mark to the product. When this has been done and all of the other CE Marking requirements have been met, the product can then be legally placed on the EU market.

Technical Documentation

A significant stage of the CE marking process is to produce technical documentation for the product to provide evidence of conformity with the relevant legislation. The technical documentation can play a vital role in protecting a company, as it will retain information on how the product was developed and how it has evolved during the production run, along with providing evidence of the efforts undertaken to ensure the product remains compliant. The name of this documentation, as well as its contents, can vary with Directives and Regulations.

‘Technical documentation’, ‘Technical Construction File’, ‘TCF’, and ‘Technical File’ are all references to the same documentation, but regardless of its official title, it is required in one form or another by all of the CE marking legislation to perform the same task. The specific contents of the Technical File can be found in the relevant annex of the specific legislation. Some of the requirements can be common across the Directives and Regulations, but to give you a good idea of what is required, we have used the technical documentation requirements given in Annex VII of the Machinery Directive.

Example
  • A general description of the product,
  • An overall drawing of the product, as well as other drawings to cover specific aspects of the product, such as circuit diagrams. Drawings shall, where appropriate, be accompanied by descriptions and explanations to understand the product.
  • Full detailed drawings, with any calculations, test results, etc., providing proof of the product’s conformity with the essential health and safety requirements of the applicable Directive/Regulation.
  • Copy of the risk assessment, which has documented the identification and mitigation of applicable risks and hazards
  • A list of standards and other technical documentation that have been applied as part of the conformity process.
  • Copies of conformity documentation for critical components of the product
  • Copies of technical reports detailing any assessments carried out.
  • A copy of the instructions and other information is supplied for the safe use of the product.
  • A copy of the manufacturer’s Declaration.

The above list is not exhaustive of what can be kept in the technical file; other relevant information may also be added. Such as information deemed to contribute to the proof of the conformity of the product that is not listed in the directive. Some information is also not required under some other Directives, such as a risk assessment. It is also worth noting that some requirements are also irrelevant if a notified body is not involved due to the nature of the product. The file must be made available to the competent authorities of the member states for at least ten years after the date that the product was last manufactured. The file does not have to be located in the European Community, but it must be made available to either the manufacturer’s authorised representative or the importer of the product as appropriate upon request.

How can we help

The CE Marking Association assists manufacturers, importers, and distributors on a regular basis with the technical documentation requirements, and we have a range of services to meet your needs. Here are some of the services on offer:

  • Technical Documentation Compilation
  • Technical Documentation Audits & Advice
  • Declaration of Conformity Checks

1. What is the Medical Device Regulation (MDR)?

The Medical Device Regulation (MDR) sets the framework for placing medical devices on the European market. To begin with, it replaces the earlier Medical Device Directive (MDD) and introduces stricter safety and performance requirements. Through this regulation, manufacturers must improve clinical evaluations, risk management, and traceability. Moreover, MDR requires a more rigorous CE Certification process to ensure that devices meet updated EU standards. By following MDR, companies strengthen product reliability and patient safety. In the end, compliance with MDR and CE Certification allows medical devices to legally enter and remain in the European Economic Area (EEA).

2. When was the MDR implemented?

The Medical Device Regulation (MDR) officially came into effect on May 26, 2017. However, to allow a smooth transition, the European Union provided a grace period. As a result, full implementation and enforcement began on May 26, 2021. From this date onward, all new medical devices must comply with MDR requirements and undergo the updated CE Certification process. This regulation replaces the previous Medical Device Directive (MDD) and ensures higher standards of safety, transparency, and performance for medical devices in the EU market.

3. WHEN DO MEDICAL DEVICE MANUFACTURERS NEED TO COMPLY WITH THE NEW MDR?

From 26 May 2020, new devices will have to meet the requirements of the MDR in order to be placed in the European market. Devices holding a certificate from a European Notified Body under either the Medical Device Directive (93/42/EEC) or the Active Implantable Medical Devices Directive (90/385/EEC) have an additional grace period and may continue to be placed on the market until 26 May 2024 if the manufacturer fulfil the specific prerequisite requirements drawn in the MDR.

4. What Are The Key Changes in the New MDR?

Some of the key changes include:

  • Product scope expansion. The definition of medical devices and active implantable medical devices will be significantly expanded to include devices that do not have a medical intended purpose.
  • Reclassification of devices according to risk, contact duration, and invasiveness. The MDR will require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.
  • More rigorous clinical evidence for class III and implantable medical devices. Manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical data to support the claims made on both the safety and performance of a dedicated device.
  • Systematic clinical evaluation of Class IIa and Class IIb medical devices. The manufacturer will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.
  • More stringent documentation.
  • Identification of ‘person responsible for regulatory compliance’
  • Implementation of unique device identification for better traceability and recall
  •  More rigorous surveillance by Notified Bodies to reduce risks from unsafe devices
  • Greater Scrutiny of Notified Bodies
  • No “grandfathering” provisions. All currently certified medical devices and active implantable medical devices must be recertified under the new requirements.

5. WHAT ARE THE IMPLICATIONS OF THE NEW MDR FOR MEDICAL DEVICE MANUFACTURERS?

The complex development process for medical devices, combined with the changes, makes the transition a complicated and time-consuming process for most device manufacturers. Because of these complexities, medical device manufacturers are well-advised to stay current on the progress of the MDR. Since a large number of medical devices are expected to require Notified Body review and delays in the review and certification process by the Notified Body should be expected. Manufacturers of currently certified devices are therefore advised to consult with their respective Notified Body to evaluate potential compliance issues and to develop a plan to address them promptly. Advanced preparation and early action will be the key to ensuring a smooth transition to the new requirements.

6. DO I NEED TO RECALL CLASS I REUSABLE DEVICES TO RE-LABEL THEM?

No, you do not need to recall devices placed on the market before May 26, 2020, under the MDD regime. To clarify, this also covers reusable Class I devices. If you placed medical devices on the market lawfully under the MDD/AIMDD before May 25, 2020, you may continue making them available and putting them into service until May 25, 2025. During this transition period, ensure you maintain proper documentation and CE Certification. By doing so, you demonstrate continued compliance while preparing for full MDR alignment.

Why Smartedge?

At Smartedge, we offer expert guidance to help your business achieve CE Certification smoothly and efficiently. To begin with, our experienced consultants understand the complexities of EU regulations and tailor solutions to meet your specific product and industry requirements. Furthermore, we provide end-to-end support—from gap analysis and documentation to testing and final CE Marking. With Smartedge, you not only ensure regulatory compliance but also accelerate your market entry. We focus on quality, accuracy, and timely delivery. Ready to get started? Contact us today and let our team guide you through the CE Certification journey with confidence and clarity.