The CE marking process for medical devices ensures that your device meets EU regulations for quality and safety. If you’re a medical device manufacturer who’s looking to get a CE certification that’s valid for three years, there are a few things you should know.
To obtain a medical device CE mark, you must adhere to the following CE marking requirements:
The European Union Medical Devices Regulation (MDR) of 2017 established rules to classify medical devices according to the following factors:
- Risk level: Devices are categorized into classes I, IIa, IIb, and III. The higher the class, the more of a risk the device is to the user.
- Body placement: Devices are classified as non-invasive if they’re used on the body’s surface, and invasive if proper use requires the device to be placed inside the body.
- Duration of use: The MDR also considers the device’s duration of use. Devices are classified as transient if they’re intended for continuous use for less than 60 minutes, short-term if they’re intended for continuous use for between 60 minutes and 30 days, and long-term if they’re intended for continuous use for more than 30 days.
Throughout the CE marking process, you should have at least one experienced person responsible for ensuring regulatory compliance within your company. If your organization is small, you can outsource a compliance expert. However, it’s important to make sure that they’re available regularly to offer their regulatory expertise.
The MDR requires manufacturers to have quality management systems (QMS) in place compliant with international standards. Since ISO 13485:2016 is in conformity with MDR requirements regarding QMS, you can use the standard as the basis for your QMS.
The ISO 13485:2016 standard covers a wide range of topics for implementing a QMS, 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
To get a CE certification, you also need to prepare technical documentation or medical device technical files. MDR requires the files to contain detailed information about your device and its lifecycle. One of the most crucial steps during preparation is the design control, also known as design dossier. This should contain information about your device’s physical characteristics and assembly, proving that it was designed in a way that minimizes the risk of injuries or accidents.
Your technical documentation should be well-organized and include:
- Your device description and specification
- Accessory and variation descriptions
- References to previous and similar devices
- Instructions for use in the country’s language where the device will be sold
- Design and manufacturing details
- Information that demonstrates conformity with the general safety and performance requirements
- Risk analysis documents
- Device verification and validation
- Your post-market surveillance plan
Your technical files should be retained for 10 to 15 years, depending on your device’s classification and requirements.
The MDR requires you to have a supplier management system. To ensure your suppliers meet compliance requirements and conformity, they’re required to undergo an audit. One way to streamline the process by creating a list of approved suppliers based on predetermined criteria to ensure only qualified suppliers provide you with device components and services. You can also simplify the process even further by choosing a supplier that’s already been audited by a Notified Body or has a certified QMS.
To obtain a CE mark, you’re also required to adhere to strict safety and performance requirements by conducting a clinical evaluation, which involves collecting and analyzing relevant clinical data from scientific literature and clinical investigations. Depending on the class of your device, you may also need to consult an expert panel.
If you’re not based in the European Economic Area (EEA), you’ll need to appoint an authorized representative inside one of the member countries to address documentation inside the EU.
Your authorized representative is responsible for:
- Verifying your technical files
- Keeping you informed about complaints
- Registering a physical place for your Notified Body to receive device samples for inspection purposes
To get a CE certification, you need to work with a CE mark Notified Body. A Notified Body is an independent organization that audits the conformity of specific devices before they can receive a CE certification and be sold across the EU. For Class I non-sterile and non-measuring devices, the certification from a Notified Body isn’t required. Instead, you can issue a self-declaration of conformity. However, for higher class devices, the Notified Body certification is mandatory and has a maximum validity of five years. To obtain this certification, the Notified Body will audit your QMS and technical documentation to verify conformity with the MDR. Once the audit is complete, you’ll receive a certification from your Notified Body. If any audit findings are present, they must be corrected and closed before another audit round is conducted. Additionally, audits and assessments occur periodically every year to ensure you’re applying the approved QMS and post-market surveillance plan.
At Remington, our QMS has been audited and approved by our Notified Body, the British Standards Institution, or BSI Group. That means that when you partner with us to manufacture your medical device, you don’t have to worry about finding a Notified Body to get a CE certification.
After getting certified by a Notified Body, you must prepare an EU Declaration of Conformity, which is a legal document that you or your authorized representative signs stating that your device complies with all of the requirements of the applicable EU directives and regulations.
Affixing a Unique Device Identifier (UDI) to each device is an additional requirement that doesn’t replace the CE marking or other labeling requirements. The identification number is a useful way to identify your medical device, which helps with accurate tracking, monitoring, and inventory management. With this traceability system, healthcare practitioners can easily obtain safety information related to your device, such as recalls, complaints, and instructions for use.
Remington Medical uses laser marking techniques to engrave UDIs on medical devices for a competitive price. Learn more about why we rely on this long lasting, non-toxic solution for many applications.
After receiving approval from national authorities and being certified by the Notified Body, manufacturers can place the CE marking on their medical devices. The CE marking should be made visible, legible, and affixed to the device itself, in the packaging, and on any instructions for use. It’s also essential that the material used can’t be washed away, since it’s an important symbol of compliance with all EU regulations. For medical devices classified as class II and III, the four-digit number of the Notified Body must also be printed alongside the CE marking.
Before commercializing your medical device in the EAA market, you must demonstrate that you have a post-market surveillance system in place to ensure patient safety and effectiveness.
Post-market surveillance (PMS) involves collecting data regarding the marketed device through vigilance, market surveillance plans, follow-up complaints, adverse events, and non-conformity cases. Your PMS plan requires you to routinely perform internal audits, supplier audits, and update safety reports, technical documentation, databases, and registers, to ensure that proactive action is taken to collect and review device quality and safety information from real-world evidence.
The EU medical device market is one of the most stringent, highly regulated markets in the world. To place your device in the EU market, adhering to this strict set of requirements is essential—but you don’t have to take the journey alone.
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