Are you looking to sell your medical device in the European Economic Area (EEA) or other new markets? If so, you need a CE mark.
A CE mark for medical devices is a label with the letters, ‘CE,’ which means Conformité Européenne, or European conformity in French. Medical devices with CE markings have been proven that they comply with European requirements that ensure safety, health, and environmental protection standards.
To ensure products meet quality and safety standards, CE marks are required for companies to distribute and sell medical devices across the EEA. The CE mark guarantees that devices meet all safety and performance standards and have been thoroughly tested to ensure they won’t cause harm to the user.
Once a device meets the EU Regulation 2017/745, also known as the Medical Device Regulation (MDR), manufacturers can market and sell their devices legally across the European Union (EU). However, the CE mark is not recognized in the United States.
The following EU member states require a CE mark to sell medical devices:
- United Kingdom
- Republic of Cyprus
- Czech Republic
To obtain a CE mark, medical device manufacturers must complete necessary steps to ensure their device meets compliance standards before applying the CE mark to their product or packaging, including:
- Ensuring the product conforms to relevant technical requirements
- Identifying if a notified body is necessary
- Performing any necessary lab testing
- Preparing technical documentation
- Preparing a EU declaration of conformity
- Ensuring the device and packaging includes the correct marks, labeling information, and warnings
- Drafting user instructions
The main difference between CE marking and FDA certification is that a CE mark is only required for devices being sold in the 33 member states of the EU, while receiving FDA certification means that the device can only be sold in the U.S.
The European Union Medical Devices Regulation (MDR) of 2017 replaced the prior Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMD). Originally, the requirements for placing medical devices on the European market took effect on May 26, 2021. However, with the European Commission proposing a deadline extension for the MDR, the deadline has been postponed to 2027 for Class III and IIb devices, and 2028 for Class IIa and I devices. With this extension, you’re granted more time to abide by MDR regulations to ensure your products are up to date with the latest safety standards.
The Directive 2001/83/EC is related to the placing of medicinal products for human use on the market. In such cases, you must identify which part of the combined product is responsible for its main activity. If the drug helps improve the medical device’s activity and can’t be used alone, it becomes an integral part of the device. In this situation, the combined product is considered a medical device and must be in accordance with EU 2017/745.
Regulation EC 276/2004 establishes the requirements for authorization, classification, labeling, packaging, and advertising of medicinal products. It also sets out criteria for quality assessment of medicinal products, including good manufacturing practices. When it comes to medical devices, Regulation EC 276/2004 works in much the same way as Directive 2001/83/EC.
The EU also requires that medical devices containing non-viable tissues or cells must comply with the requirements of the MDR, meaning that even if the main purpose of the device isn’t related to these tissues or cells, the general safety and performance requirements of the MDR must still be applied to the part of the device containing those elements.
For manufacturers of medical devices, adhering to the ISO 13485:2016 standard is a necessary step in order to ensure compliance with the Quality Management System (QMS) requirements presented in the MDR. This standard outlines the requirements of a QMS for medical devices and provides a framework to follow.
The ISO 13485:2016 standard covers a wide range of topics, including:
- Quality manual
- Document and record control
- Quality management system
- Human resources
- Manufacturers infrastructure
- Contamination control
- Design and development planning, verification, validation, transfer, changes, and files of medical devices
- Evaluation and selection of suppliers
- Complaint handling
- Control of nonconforming products and post-market surveillance
- Servicing activities
- Requirements for sterile medical devices
- Identification and traceability of medical devices
ISO 14971:2019 was specifically developed for medical device manufacturers based on established risk management principles. While compliance with ISO 14971:2019 isn’t required to obtain a CE mark, it provides you with the guidance needed to understand and implement the principles of risk management in your processes and ensures you meet MDR requirements.
If you’re targeting the US market, you must be QMS compliant with FDA 21 CFR Part 820 and FDA clearance. If you want to enter the European market, this FDA regulation isn’t mandatory, but it can still serve as a guideline for meeting QMS requirements set out by MDR. While many companies opt to follow the ISO 13485:2016 standard since it’s certifiable, understanding the FDA’s requirements can be beneficial in creating a robust, comprehensive QMS.
The MDR changes have had a significant impact on the CE marking process. For example, manufacturers must now provide detailed information about the product’s design and performance and demonstrate how they intend to comply with the MDR’s requirements. Manufacturers may also experience changes in how they classify their device and prove that their products are compliant with EU standards and that they have conducted the necessary tests.
If you want to continue to supply approved medical devices to the EU market beyond May 2021, complying with the EU MDR changes will require a lot of additional work. Read our blog for more information on how to begin complying with the new EU MDR changes.
CE marking is an essential requirement when selling products within the EEA, but it’s also a great way to prove to customers that your device meets safety and quality regulations and standards. Since a CE mark allows commercialization in all 33 member countries of the EEA, you can easily expand your business to Europe. Some countries outside the EEA also accept CE marking, which is an advantage if you’re looking to expand into new markets.
CE marking indicates that your device complies with essential EU legal requirements, giving patients peace of mind that they’re using a safe, quality product designed and tested to meet safety and performance standards.
With more than 30 years of experience in medical device manufacturing, Remington Medical knows a thing or two about MDR and FDA regulations. Contact us today, and one of our experienced professionals can walk you through the CE marking process.
- FAQs About CE Marking for Medical Devices September 4, 2023
- How Are Medical Devices Classified Under EU MDR? August 31, 2023
- How to Get a CE Certification for Your Medical Device August 3, 2023