You want to sell your device in the European Union and start the CE marking process. But after reviewing the MDR and the guidance documentation, you begin to doubt the CE mark process.
Are clinical evaluations before or after product development? Do you need post-market surveillance or post-market clinical follow-up? And what even is a UDI??
Don’t worry; we got you!
This article will walk you through the CE marking process in the European Union and give a high-level overview of the different processes required to obtain CE mark.
If you have any further questions, you can always reach out to us – at Citemed, we focus on clinical evaluations and literature reviews, but our consultants are some of the most knowledgeable in the industry. They can also guide you the CE marking process!
CE Marking Requirements – What does it mean for medical devices?
The CE mark certification is required for every device intended to be marketed and sold in the European Union. CE stands for “conformité européenne,” which literally means “European Conformity” in French.
The CE mark certifies that your product and its technical documentation have undergone strict conformity assessment and can be sold in the European member states.
CE markings are affixed to all sorts of products, from electrical equipment to medical devices. It is important to note, though, that the CE mark is not a safety mark – not all products require CE marking to be sold in the EU, and not all products that do carry CE marking have undergone third-party assessment.
In the case of medical devices, CE marking certifies that the medical device meets the General Safety and Performance Requirements (GSPRs). Only the lowest risk devices (Class I self-certified) are exempt from notified body conformity assessment to obtain CE marking.
Before you can get a clear idea of the CE marking requirements for your device, you must classify it. Medical devices are classified according to risk into Class I, Class IIa, Class IIb, and Class III.
Besides the general classification, you also need to determine the invasiveness and duration of use of your device.
Person Responsible for Regulatory Compliance
Any medical device manufacturer should appoint at least one person responsible for regulatory compliance under the MDR. This person should be appropriately experiences in the field.
Quality and risk management systems
It is a key requirement of the MDR to have quality and risk management systems in place. If you’re a low-risk device manufacturer, you might be thinking whether this is really necessary.
The short answer is: Yes, every medical device manufacturer should have proper quality and risk management systems implemented.
Your technical documentation is the meat of your regulatory submission and contains all the detailed information about your medical device. You must update it throughout the lifetime of the device and keep it available and updated at all times.
The technical documentation contains all the different documents regarding your device, such as device descriptions, clinical evaluations, design and manufacturing documents, verification and validation, risk analysis documents, post-market surveillance plans and reports, and everything else required by the MDR.
One of the more difficult processes in the MDR, supplier management is nonetheless a critical part of the CE marking process.
Suppliers must be audited, and there are various items required in the supplier management process, such as approved supplier lists, audit plants, supplier details and manufacturer information, etc.
To appropriately demonstrate compliance with the General Safety and Performance Requirements, every medical device manufacturer must perform continuous clinical evaluation.
In the clinical evaluation, clinical data must be collected from a variety of sources and be appraised and weighted to summarize on the acceptability of your device’s benefit-risk profile (something that can drive even the most experienced regulatory professional to the edge, ahem).
If you are not based in the European Economic Area (EEA), you should appoint an authorized representative. This representative is responsible for verifying all your technical documentation, forwarding complaints and incident reports to the manufacturer, and providing a place for the notified body to receive samples for inspection.
Essentially, the authorized representative is the person responsible for the management of your device and its behavior in the EU in the eyes of the competent authority.
Notified Body Conformity Assessment
The notified bodies are third-party organizations designed to ensure a product complies with the current regulation within the EU and the requirements for CE marking. Through their conformity assessment procedure, the notified bodies are responsible for auditing and certifying manufacturers to CE mark (except manufacturers of Class I self-certified devices).
The notified bodies essentially review all the quality management and technical information of the device and will typically return to the manufacturer with a list of non-conformities. Once the non-conformities are corrected, the device can be nofitied body certified.
EU Declaration of Conformity
Once the notified body has issued the certification, the manufacturer must produce a declaration of conformity. The declaration of conformity states that the manufacturer assumes responsibility for the compliance to the MDR requirements.
Unique Device Identifier (UDI)
Every medical device on the market should be assigned a unique device identifier (UDI) to ensure traceability of each device model. The UDI is a device-specific code that allows critical information about the device to be found through the European Database on Medical Devices (EUDAMED).
Add your CE marking to your device
And after aaaaall of that, you can finally add the CE marking to your medical device! The CE marking should be added to the device itself, to the packaging, and to any instructions for use or manuals provided for the device.
The CE mark must be visible, legible, and made with a material that does not wash away. For higher-risk devices, the four-digit number of the notified body should also be added alongside the CE marking.
You already demonstrated in your technical file that you have a proactive post-market surveillance system set up. Once your CE marked device is on the market, it is time to start implementing your post-market surveillance system.
Post-market surveillance data should be collected throughout the lifetime of the device and be implemented in the continuous loop that is post-market surveillance, risk management, and clinical evaluations.
Essentially, you are evaluating the behavior of the device in the market and the patient’s and healthcare professionals’ experience with the device. The information collected is then analyzed, processed, and fed back into the rest of the technical documentation.
Congratulations – you have obtained your CE mark!
For most manufacturers, the CE marking process takes years and it can be easy to think the CE mark is the finish line.
However, the CE marking is just the start of the marathon. Once you affix the CE marking to your product, the never-ending tasks of maintaining the technical documentation, performing clinical evaluations, processing post-market surveillance data, and updating risk management documents start in earnest.
CE marking conformity assessment can be a heavy task, especially with the update to the MDR and the increased requirements that came with it. For anyone looking to market and sell devices in the EU, though, it is absolutely vital.
Need help getting started? Schedule a free consultation call with one of our partners to create a customized plan for your business.