Six Steps To CE Mark Your Medical Product24 October 2018
From the laptop you use at work to the pint glass down the pub, most of the products we surround ourselves with are marked with a “CE”. Look at your mobile phone; the casing, battery, and charger should all be CE marked. What does this marking mean and how can those with a new product secure one?
Contrary to the popular opinion that CE means Conformity Europe, it doesn’t actually stand for anything. What it represents, however, is a different matter altogether. Any item that bears the CE mark meets the requirements of an appropriate European Directive and therefore has the right to freedom of movement within the EU. Simply put, a CE mark could be described as the “passport” for a product within the EU.
How do I CE mark a product?
Manufacturers play a crucial role in ensuring that products placed on the Single Market are safe. They are responsible for checking that their products meet EU requirements and ultimately affixing the CE marking to a product. Only then can it be traded on the EEA market. Here are the six steps required to gain a CE marking:
1. Identify the appropriate directive(s) and standards
2. Verify any requirements that are specific to your product
3. Identify whether you can self-certify or if notified body* involvement is required
4. Test the product to check it fulfills any requirements
5. Draw up the required technical documentation and make it available
6. Apply the CE marking and issue an EU Declaration of Conformity
*Some products will require the involvement of a notified body. Items such as gas boilers and chainsaws pose a higher safety risk, and so cannot be checked by the manufacturer alone. In these cases, an independent organisation, specifically a notified body appointed by national authorities, has to perform the safety check. This is also why some CE markings have a number after them, representing the notified body involved in the certification.
How do I CE mark a medical device?
Due to a 4 tier classification system and increased N.B involvement, CE marking medical devices can be slightly more complicated.
Class I: The first class of devices is regarded as low risk. This includes standard items such as walking sticks, wheelchairs, and spectacles, but also sterile, measuring, and reusable instruments. Notified body involvement is not required for most devices in this class but for anything that measures or anything sterile, they will ensure measurements are accurate and the sterilisation process is appropriate.
Class IIa: For low to medium risk items such as dental crowns or contact lenses, manufacturers will be looking at certifying for Class IIa devices.
Class IIb: Medium to high-risk items such as dental implants or contact lens cleaning solution would then come under Class IIb and require further levels of scrutiny.
For Class IIa & 11b, notified bodies will now need to review the technical file to confirm the device meets the requirements of the directive as well as undertaking periodic reviews and quality system audits.
Class III: Devices such as pacemakers and joint implants are considered as high risk and therefore require more input from a notified body. Not only will they undergo Class II testing, but they will review and approve/decline the design dossier for the device. As with Class II devices, the manufacturer will also be subject to audits both on the quality system and the technical documentation.
What are the next steps for a manufacturer of medical devices?
The current directive (MDD) for CE compliance is set to change to a regulation (MDR) by 2020. This deadline is fixed, so a smooth transition can be gained by preparing to meet the new requirements and training staff to understand them. For more information on the changes that the MDR will bring, read our recent article entitled Brexit, EU Regulation, and UK innovation.