What Is a CE Mark for Medical Devices?

In this blog, we’ll cover the following topics related to CE marking for medical devices:

What Is a CE Mark for Medical Devices?
Why Is a CE Mark Required for Medical Devices?
What Countries Require the CE Mark?
What’s Required for a CE Mark on Medical Devices?
What’s the Difference Between a CE Mark and FDA Certification?
How Are MDR Changes Impacting CE Marking?
The Benefits of CE Marking

What Is a CE Mark for Medical Devices?

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.

Why Is a CE Mark Required for Medical Devices?

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.

What Countries Require the CE Mark?

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:

Switzerland
Australia
Austria
Belgium
United Kingdom
Israel
Turkey
Norway
Iceland
Serbia
Canada
Singapore
Iceland
Bulgaria
Croatia
Republic of Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal

What’s Required to Obtain a CE Mark for Medical Devices?

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

What’s the Difference Between a CE Mark and FDA Certification?

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.

Let’s break down the following standards and regulations to give you a better understanding of how the CE marking process works:

Regulation (EU) 2017/745
Directive 2001/83/EC
Regulation (EC) 276/2004
Directive 2004/23/EC
ISO 13485:2016
ISO 14971:2019
FDA 21 CFR Part 820

Regulation (EU) 2017/745

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.

Directive 2001/83/EC

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

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.

Directive 2004/23/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.

ISO 13485:2016

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

Medical device traceability ensures that devices and the materials they’re manufactured with can be tracked. Check out our blog about medical device traceability here for more info.

ISO 14971:2019

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.

FDA 21 CFR Part 820

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.

How Are MDR Changes Impacting CE Marking?

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.

The Benefits of CE Marking

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.

Key Takeaways

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.