Understanding the CE marking process can be daunting.
A CE mark for medical devices is a label with the letters CE printed directly on the device, which means Conformité Européenne, or European conformity in French. Medical devices with CE markings have proven they comply with European requirements for safety, health, and environmental protection. The CE mark is not just about the letters. EU MDR 2017/745, Annex V depicts a specific font and spacing that must be used.
The CE mark is mandatory for medical devices to be sold in the following 29 member states of the European Union (EU):
- Republic of Cyprus
- Czech Republic
CE marking is mandatory, even if the medical device was manufactured outside of the EU.
A notified body is an essential part of the CE conformity process for certain products in the EU. Notified body organizations have the important task of assessing the conformity of products, reviewing technical files and test reports, and inspecting production facilities. Notified Bodies are designated by the EU. As such, they’re authorized to grant manufacturers certificates under the EU MDR 2017/745 which allow the manufacturers to apply the CE-mark to their products and gain access to the EU market.
The validity period of CE certificates for medical devices is generally three years. However, for high-risk devices, this period may be as short as one year. The status of your CE certification also depends on your ability to maintain your quality system certification.
A 510(k) is the regulatory pathway that medical device manufacturers must follow to gain clearance from the FDA to market devices in the U.S. On the other hand, a CE mark indicates that a medical device meets the safety, health, and environmental protection requirements set by the EU to commercialize devices in all 33 member states.
If you’re a medical device manufacturer based in the U.S., you’ll need to appoint an authorized representative in one of the member states to address documentation in the EU. To help you obtain a CE certification, the representative will verify your technical documentation, keep you informed throughout the process, and register a physical place for your notified body to receive device samples for inspections.
The Declaration of Conformity is a crucial document signed by manufacturers or authorized representatives to ensure that medical devices sold in the EU meet the directives and regulations. However, the manufacturer mentioned in the document isn’t always the one who physically made the device. It could be their authorized representative or notified body who assumes this responsibility.
Illegally affixing the CE marking to a medical device or selling products that don’t meet EU regulations and harmonized standards can lead to serious consequences, such as products being removed from the market.
The time it takes to obtain CE certification depends on a variety of factors, such as risk class of device, type of device, backlog of submissions at the notified body, etc. The actual time may range from a few months to a few years.
Yes. As the owner of the CE mark, you need to carefully select a new contract manufacturer based on the criteria outlined in your quality system. This system should outline how to qualify and continually assess suppliers. You also need to notify your local notified body about this change and request an updated CE certificate. It’s important to note that the notified body might even require an onsite audit of the new contract manufacturer before approving the change and issuing a new CE certificate. This all must be completed BEFORE placing products manufactured by the new CM on the EU market.
The EU passed 2023/607 in February 2023, which extended the implementation of EU MDR 2017/745 to December 31, 2027 for high risk devices and December 31, 2028 for lower risk devices. It also granted Notified Bodies the authority to provide extension letters for devices CE-marked under MDD 93/42/EEC and AIMDD 90/385/EEC all the way to the dates above.
For reusable medical devices, the CE marking can be affixed on the back or underside of the device, as long as it’s visible and legible. To ensure readability, it must be at least 5 mm in height. However, for small devices or components, the minimum dimension requirement for the CE marking can be waived. However, when it comes to disposable medical devices, the CE mark isn’t required to be printed directly on the device. For single-use, disposable devices, the CE mark only has to be on the labeling.
Remington Medical’s laser marking solutions are non-intrusive, cause no corrosion, and stand up to the tests of time.
CE marking indicates that your device complies with essential EU legal requirements, giving patients peace of mind that they’re using a safe device 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 answer any other questions you may have about the CE marking process.
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