To sell and market your medical device across the European Union (EU), you must have a CE marking of conformity.
Manufacturers of medical and in vitro diagnostic devices that wish to be part of the European Economic Area market must adhere to regulatory requirements to ensure their products meet quality and safety standards.
Legislation and international standards regarding medical devices, such as EU MDR 2017/745 and ISO 13485:2016, can be complex to follow but is essential to life science organizations’ success. Not following these regulations and standards can lead to manufacturers stopping their production altogether.
In this article, we will learn about the principal regulations for obtaining CE marking, followed by a step-by-step guide to getting a medical device’s CE marking. We will also visit some of the most common questions regarding this matter and see how an Electronic Quality Management System (eQMS) can help you streamline the process to have a declaration of conformity.
One of the best ways to streamline your processes to obtain a CE marking nowadays is to use eQMS software. SimplerQMS offers a cloud-based eQMS for medical devices that supports regulatory compliance, audit process, document control, all the technical documentation you will need, and much more. Book a demo with one of our quality solution experts and be a step closer to your CE marking!
We will cover the following topics:
- What Is CE Marking for Medical Devices?
- Why Is CE Marking Important?
- Relevant Standards and Regulations
- How To Obtain CE Marking for Medical Devices?
- SimplerQMS Streamlines CE Marking Process
- Frequently Asked Questions About CE Marking
What Is CE Marking for Medical Devices?
CE marking means Conformité Européenne or European conformity in French. And as the name suggests, it proves product compliance with European requirements that ensure specific safety, health, and environmental protection standards.
It can be required for several different products. Regarding medical devices, the CE marking allows companies to move and sell their devices across the 30 countries of the European Economic Area (EEA) once they follow the EU Regulation 2017/746, also known as Medical Device Regulation (MDR).
The MDR is the European regulation concerning placing medical devices and accessories on the market for human use.
Another similar legislation is EU 2017/746 for in vitro diagnostic devices, referred to as In Vitro Diagnostic Regulation or IVDR. However, IVDR is not the aim of this article.
So, to summarize, the letters ‘CE’ on medical devices represents a product that meets all legal requirements to be traded throughout the EEA. Manufacturers know their devices can be sold and marketed legally, and patients benefit from a safe device.
Why Is CE Marking Important?
All medical devices that comply with European legislation can obtain a CE marking.
A product cannot be legally sold and marketed in EEA countries without it. Devices used exclusively for research are the only exception and can enter these countries.
Complying with this regulation brings opportunities for many companies worldwide to expand their business.
CE marking indicates that the medical device went through risk assessment processes and is a safe and high-quality product for the patient.
For instance, during the COVID-19 pandemic, lots of infrared thermometers were placed on the European market. Regardless of the manufacturer’s country of origin, the CE marking indicates that these devices comply with requirements and can be legally sold and marketed in the EEA countries.
Let’s see some of the key benefits of having a CE marking:
- Indicates that your device complies with essential EU legal requirements.
- Allows commercialization in all 30 member countries of the EEA.
- Some countries outside EEA accept CE marking, which is an advantage when entering other new markets.
- Indicates your device meets safety and quality regulations and standards.
An essential step for obtaining a CE marking is to implement a Quality Management System (QMS). Implementing a medical device eQMS software is a smart decision that has been helping several manufacturers to comply with the MDR and IVDR.
Over the last decade, an increasing number of companies of all sizes have been migrating from paper-based or hybrid QMS systems to specific QMS software solutions.
SimplerQMS is one such solution, providing an end-to-end quality management software that helps medical device and other Life Science companies streamline their quality processes, speed up time to market, and improve compliance with international standards and regulations such as ISO 13485 and MDR.
Relevant Standards and Regulations
It is essential to know the regulations and standards involved in medical devices. We will break down the most important international standards and regulations you need to know to understand better how the CE marking process works.
Regulation (EU) 2017/745
The regulation EU 2017/745, also referred to as the Medical Devices Regulation or MDR, is the current regulation that replaces the previous Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD) entirely.
The regulation describes all the mandatory procedures, transition arrangements, and explanations. If you are a medical device manufacturer, please always refer to this regulation for accurate information.
Although it was published in 2017, the requirements for placing medical devices on the European market only took effect on 26 May 2021.
According to MDR, transition arrangements allow some devices already on the market with MDD to remain available until 27 May 2025.
However, as we write this article, the European Commission proposes a deadline extension postponing the MDR deadline of 26 May 2024 until 2027 for Class III and IIb devices and May 2028 for Class IIa and I devices.
Directive 2001/83/EC is related to placing medicinal products for human use on the market.
When medical devices are combined with a medicinal product, such as a drug, manufacturers need to determine which part of the combined product is responsible for its main activity.
If the drug helps improve the medical device’s activity and cannot be used alone, it becomes an integral part of the device. 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 is related to placing medicinal products for humans and veterinary use on the market.
Regarding medical devices, it works the same way as Directive 2001/83/EC.
The directive 2004/23/EC sets quality and safety standards for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells.
Medical devices containing non-viable tissues or cells with a secondary activity must comply with MDR.
EU MDR’s general safety and performance requirements must apply to the part of the device containing those elements, regardless of their main activity.
Medical devices — Quality management systems — Requirements for regulatory purposes.
The ISO 13485:2016 standard outlines the requirements of a QMS for medical devices.
Manufacturers of medical devices usually adhere to this standard since following it presumes compliance with QMS requirements presented in the MDR.
Following this standard indicates compliance with QMS requirements, such as:
- 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
- Servicing activities
- Requirements for sterile medical devices
- Identification and traceability of medical devices
- Complaint handling
- Control of nonconforming products
- Post-market surveillance
Medical devices — Application of risk management to medical devices.
ISO 14971:2019 was developed specifically for medical device manufacturers based on established risk management principles and can be used as guidance in developing and maintaining processes.
Risk management is a requirement of MDR. However, manufacturers can achieve compliance without the need to be certified by this ISO.
FDA 21 CRF Part 820
The FDA 21 CRF Part 820 establishes quality system requirements applicable to medical device manufacturers. It is the current regulation of QMS for medical devices used in the United States.
Medical device companies targeting the US market must have a QMS compliant with FDA 21 CFR Part 820 and FDA clearance.
This code of regulation can serve as a guideline for the QMS requirement of MDR in the European market. However, most companies choose to follow ISO 13485:2016 standard, since it can be certified.
How To Obtain CE Marking for Medical Devices?
Obtaining a CE marking can be rather complex, so to assist you, this guide will outline the general steps of this process.
Keep in mind that this guide is for educational purposes. For complete information, medical device manufacturers should always refer to the MDR.
Many companies hire consulting firms to manage CE marking processes in parts or whole. However, due to the recent MDR implementation, these professionals are in high demand, so it can be difficult to get a hold of them.
The process of placing a medical device on the market generates a high volume of documents. An eQMS can help manufacturers manage all this data accurately, facilitating compliance with QMS requirements in MDR.
To ensure documentation is already being created following requirements, having a Medical Device Quality Management System in place is a good start.
SimplerQMS supports compliance with all the requirements mentioned above by providing a fully validated eQMS that helps companies manage quality throughout the product life cycle. In the following sections, we will showcase a few more examples of how an eQMS can help streamline some of the processes needed to obtain a CE marking.
Let’s see a brief overview of the steps before going further:
- Determine Your Medical Device Classification
- Designate a Person Responsible for Regulatory Compliance
- Implement a Quality and Risk Management System
- Prepare Technical Documentation
- Implement Supplier Management System
- Conduct a Clinical Evaluation
- Assign a European-Authorized Representative (if Applicable)
- Obtain Certification by a Notified Body
- Prepare a Declaration of Conformity
- Register Your Device Under a Unique Device Identifier
- Affix a CE Marking to the Medical Device
- Maintain a Post-Market Surveillance
The general steps of the CE marking are outlined in no particular order.
1. Determine Your Medical Device Classification
The MDR established rules to classify medical devices according to the risk level, placement on the body, and duration of use.
We will cover them briefly in this article, but you can read our medical device classification guide for more detailed information.
Devices are divided into classes I, IIa, IIb, and III.
The higher the classification, the higher the risk the device represents to the patient.
Devices can be non-invasive when they are on the body’s surface and invasive when they penetrate inside the body.
There are also active devices that depend on a source of energy other than that generated by the human body.
For example, an X-ray machine, patient monitor, and hearing aid are non-invasive class II devices placed on the body’s surface that are also active since they do not depend on the human body as a source of energy.
On the other hand, a pacemaker is an invasive and active class III device because it needs to be placed inside the body to fulfill its purpose.
Duration of Use
The duration of use is also gradual, being a transient use of up to 60 minutes, a short-term use of up to 30 days, and above that period, it becomes a long-term use device.
The regulation also brings 22 rules to help manufacturers correctly classify their devices. Those rules specify the class of a device based on its application and how this class can vary depending on body placement, duration of use, and increased risk to the patient.
For instance, catheters and intraocular lenses are considered medical device class II since both are invasive. However, catheters are intended for transient or short-term use, putting them in the IIa class.
But intraocular lenses have long-term use. Therefore, they are considered at higher risk, being marked as class IIb.
2. Designate a Person Responsible for Regulatory Compliance
Medical device manufacturers must have at least one person responsible for regulatory compliance within the company. And this person needs to have expertise in the field of medical devices.
If you are still a small organization, there is no need to have personnel on-site. But this person has to be available permanently and continuously.
3. Implement a Quality and Risk Management System
The MDR requires manufacturers to have quality and risk management systems.
That is why medical device companies chose to comply with ISO 13485:2016 because it is presumed to be in conformity with MDR requirements regarding QMS.
A QMS software solution like SimplerQMS can streamline and automate many aspects of quality management, from document control and change management to training, audits, suppliers, non-conformances, CAPAs, and more.
4. Prepare Technical Documentation
Technical documentation, also known as medical device technical files, contains detailed information regarding your medical device lifecycle and is a requirement of MDR.
A crucial process is the Design Control or Design Dossier, which contains information about a device’s physical characteristics and construction. It must prove that the medical device was designed in the best way possible to minimize the risk of injuries or accidents.
To achieve compliance, all documentation needs to be well organized, readily accessible, and easy to understand.
It includes, but is not limited to:
- Device description and specification
- Description of the accessories and variations
- Reference to previous and similar generations
- Instructions in the country’s language in which the device will be sold
- Design and manufacturing information
- Information for the demonstration of conformity with the general safety and performance requirements
- Risk analysis documents, such as design risk, production risk, biological risk, and so on
- Product verification and validation
- Post-market surveillance plan
These documents must be retained for a period of 10 to 15 years, depending on the device classification and customer requirements.
SimplerQMS helps with the compilation of Technical Documentation. Using our robust design controls and cloud-based storage, medical device manufacturers have the support to achieve compliance with the MDR.
5. Implement Supplier Management System
MDR requires medical device companies to have supplier management. Suppliers must be audited to ensure compliance with requirements and conformity.
It is helpful to create a list of approved suppliers based on predetermined criteria to ensure only qualified suppliers provide products and services.
In accordance with the MDR, medical device manufacturers’ suppliers can, if needed, be audited by external organizations, known as Notified Bodies. The audits can be announced or unannounced.
The supplier audit can be simplified if they have already been audited by a Notified Body or have a certified QMS.
SimplerQMS solution assists you with your supplier management processes by providing a centralized repository for all your supplier information, maintaining an Approved Supplier List (ASL), creating an audit plan, as well as other reoccurring supplier-related tasks, and receiving notifications when scheduled tasks are due.
6. Conduct a Clinical Evaluation
Manufacturers must conduct a clinical evaluation to demonstrate conformity with safety and performance requirements.
Practically, it means a plan to collect and analyze clinical data from relevant scientific literature and clinical investigations involving the specific medical device or an equivalent product.
Manufacturers must also consult an expert panel for devices in classes IIb and III.
7. Assign a European-Authorized Representative (if Applicable)
If a medical device manufacturer is not based on the EEA, they will need to appoint an authorized representative inside the member countries.
The authorized representative is responsible for actions such as:
- Verifying the technical documentation
- Informing the manufacturer about complaints
- Registering a physical place for the Notified Body to receive samples of the device for inspection
Imagine a medical device manufacturer from Canada who wishes to enter the EU market to sell pacemakers. To do so, they will need a European representative to address their documentation inside Europe.
8. Obtain Certification by a Notified Body
Notified Body is an independent organization designed to assess the conformity of specific products before their placement on the market.
Regarding medical devices, they are responsible for auditing and certifying manufacturers concerning the conformity of devices with MDR.
A list of valid Notified Bodies can be found in the New Approach Notified and Designated Organizations (NANDO) system.
A Notified Body does not need to assess manufacturers of class I non-sterile and no measuring devices. In these cases, companies can issue a self-declaration of conformity.
For higher classes devices, this certification is mandatory, specific for each procedure, and has a maximum validity of five years.
The Notified Body will then audit the manufacturer’s QMS and technical documentation to verify conformity with the MDR. This is a critical part of the process.
Manufacturers will receive a certification from the Notified Body once the audit is complete. In the case of audit findings, those must be corrected and closed before another audit round is conducted.
Audits and assessments occur periodically every year to ensure companies are applying the approved QMS and post-market surveillance plan.
9. Prepare a Declaration of Conformity
After being certificated by a Notified Body, manufacturers must draw up a Declaration of Conformity, assuming responsibility that the requirements specified in MDR have been fulfilled.
10. Register Your Device Under a Unique Device Identifier
To facilitate the traceability of medical devices, a unique device identifier (UDI) needs to be assigned individually to specific device models.
The UDI is a unique number or alphanumeric code stored in the European Database on Medical Devices (EUDAMED), where crucial information about the device can be found.
Affixing the UDI is an additional requirement. And it does not replace the CE marking or other labeling requirements.
11. Affix a CE Marking to the Medical Device
After being approved by national authorities and certified by the Notified Body, manufacturers can place the CE marking on their medical devices.
The CE marking must be affixed to the device itself, in the packaging, and on any instructions for use.
It is crucial for the CE marking to be visible, legible, and made with a material that cannot be washed away.
For medical devices class II and III, the four-digit number of the Notified Body also needs to be printed alongside the CE marking.
12. Maintain a Post-Market Surveillance
Before obtaining a CE marking and placing a medical device into the EAA market, manufacturers need to demonstrate that a post-market surveillance system is already in place to address questions on safety and effectiveness.
Medical device companies must collect data regarding their marketed devices through post-market surveillance, vigilance, and market surveillance plans.
This feedback involves continuously evaluating the patient’s experience with the medical device and the product life cycle.
Requirements of manufacturers are:
- Follow-up complaints, adverse events, and non-conformity cases
- Update safety reports periodically
- Perform internal audits and supplier audits routinely
- Keep technical documentation, databases, and registers updated
This surveillance ensures proactive action to collect and review device quality and safety information from real-world evidence. Therefore, manufacturers can better address customer complaints, identify risks, and implement recalls and other market actions.
For more details, you can also read your article about Post-Market Surveillance (PMS) for medical devices.
A smart way to handle your device PMS is by implementing an eQMS with features such as built-in forms for handling non-conformance and complaint events that allow for automated linking and processing of Corrective and Preventive Actions (CAPAs).
SimplerQMS software offers all of that and more. Medical device companies can easily link any PMS issue to a specific device, component batch, customer complaint, and equipment failure.
In Great Britain (England, Scotland, and Wales), the CE marking is still valid until June 2023 for manufacturers who wish to sell their medical devices in this market.
Afterward, the CE marking will no longer be accepted, and a UK Conformity Assessed (UKCA) marking will be required.
For instance, after June 2023, a medical device manufacturer from Germany that wants to place their device in the Great Britain market will need to obtain a UKCA marking.
And the opposite also applies. This means a company from England must have a CE marking to sell into the EEA market.
Both organizations, in this example, must appoint an authorized representative inside the market they wish to operate.
SimplerQMS Streamlines CE Marking Process
There are many steps to obtain the CE marking, and there is even more documentation for each step.
Managing these documents is challenging enough, and more so with a paper-based QMS. Even with a hybrid system, important documents can be lost, filled in wrongly, and taken too long to access during an audit.
Storage is also an issue when using physical files. Keeping a significant number of documents for up to 15 years or even more can be troublesome space-wise.
Here are some exciting features medical device eQMS, such as SimplerQMS, offers:
- QMS software facilitates the process of compiling technical documentation by keeping all relevant information in one location and making it easy to share and access.
- Allows the development of documents using best-practice ISO 13485:2016 templates and forms.
- Automates various documentation processes, freeing your team to focus on more critical tasks and saving time while ensuring consistency and accuracy of information.
- Simplifies the auditing process, as the system ensures accurate and readily available documents in a cloud storage system.
- Helps maintain your CE marking of conformity, as it already has post-market surveillance plans and processes to deal with complaints and adverse events.
- Helps you keep the documentation organized for as long as required for your medical devices without compromising physical space.
With the MDR in place, transitioning can be much easier using an eQMS solution.
SimplerQMS provides a cloud-based quality management software built to help medical device companies comply with Life Science requirements and obtain their CE marking.
The software solution automates and facilitates your quality management processes, saving valuable time and resources while helping you ensure compliance.
We provide a fully validated system according to GAMP 5 and conduct continuous re-validation, so there is no need to spend time and money on validation yourself. SimplerQMS takes full responsibility for our solution and provides audit assistance related to eQMS software.
If you are interested in implementing an eQMS solution in your company, go ahead and download our eQMS Business Case template. With this, you can calculate the real economic benefit and time advantages of an eQMS versus a manual or paper-based system!
Frequently Asked Questions About CE Marking
Is CE Marking the Same as FDA Approval?
European CE marking and United States FDA approval both have the same goal – to assess the safety and efficacy of medical devices. However, they are only valid in the markets on which they are based.
Which Countries Require CE Marking for Medical Devices?
CE marking is required in the countries of the European Economic Area, which encloses the EU countries as well as Iceland, Norway, Lichtenstein, and Switzerland.
How Long Does CE Marking Approval Take?
CE marking approval times are variable. It depends on the class and complexity of the device, as well as whether the manufacturer has a QMS in place and is already ISO 13485:2016 certified. Usually, obtaining a CE marking can take 16 to 18 months from beginning to end.
How Long Is a CE Marking Valid?
CE marking validity will be determined by the Notified Body and depends on the medical device classification, but it cannot exceed five years. After that, the device needs to be re-certificated.
For instance, a class IIa device can receive a certificate valid for just three years.
Moreover, annual surveillance audits are conducted between certifications.
Can I CE Mark My Own Medical Device Product?
Medical devices class I non-sterile and no measuring types can be self-declared. However, higher classes need to be assessed by Notified Bodies to receive a CE marking.
How Many Notified Bodies Are There For the CE Marking?
According to the NANDO database, in the year 2022, 34 Notified Bodies are authorized for MDR and 7 for IVDR.
Is CE Marking the Same As UKCA Marking?
Both CE marking and UKCA marking share the same goal – to ensure the safety and quality of products. But CE marking is specific to the EEA market, and UKCA marking is exclusive for products placed in Great Britain (England, Scotland, and Wales).
Obtaining a CE marking is a mandatory step for medical device manufacturers that intend to sell their products on the EEA market.
This can be a somewhat complex process involving a high volume of technical documents that must be accurate and in compliance with standards and regulations.
Thus, having QMS software in place is a smart decision to manage all information about medical devices successfully.
SimplerQMS provides a QMS software solution that supports compliance with MDR and ISO 13485:2016 and helps medical device organizations of all sizes streamline their CE marking process.
If you are interested in streamlining quality management processes and making compliance simpler for your business, book a demo and talk to our experts today!