To sell your medical device across the European Union, 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 need to adhere to regulatory requirements to ensure their products meet quality and safety standards.
Legislation 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 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 cover 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, Directives, and Regulations
- How To Obtain CE Marking for Medical Devices?
- How 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, but 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 lays down rules concerning placing medical devices and accessories on the market for human use. Another similar and essential requirement is EU 2017/746 for in vitro diagnostic medical devices, referred to as IVDR. Those will be discussed in more detail further ahead.
So, to summarize, the letters’ CE’ on medical and in vitro devices represents a product that meets all legal requirements to be traded throughout the EEA. Manufacturers know their devices can be sold without restriction, and patients benefit from a safe device.
Why Is CE Marking Important?
All medical and in vitro diagnostic devices must have a CE marking to comply with European legislation. Without it, a product cannot enter another EEA country legally. Even if a medical device manufacturer is based outside Europe, a CE marking is mandatory to trade in this market.
Let’s say a dental implant manufacturer is based in Hungary. Without the CE marking, they can only sell their devices inside the home country. However, when obtaining a CE marking, they can expand the business to all member countries of the EEA.
Complying with this regulation brings opportunities for many companies worldwide to expand their business.
The CE marking is also essential for patients – once noting that the medical device has this certificate, they can be sure the device is safe and of high quality.
For instance, during the COVID-19 pandemic, lots of infrared thermometers were placed on the European market. These devices must present a CE marking to ensure quality. Faulty equipment can lead to a wrong measurement and misidentify a fever in a possibly sick individual.
Let’s see some of the key benefits of having a CE marking:
- Proves your device complies with essential legal requirements
- Allows commercialization across all 30 countries in the EEA
- Demonstrates your device meets safety and quality standards
- Provides credibility to your organization in the eyes of your patients and customers
And, of course, an indispensable step for obtaining a CE marking is to implement a QMS. Documentation quality is always a significant component of accreditation.
Implementing a purpose-built medical device QMS 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 solution that helps medical device companies streamline their quality processes, speed up time to market, and improve compliance with international standards such as ISO 13485 and MDR.
Relevant Standards, Directives, and Regulations
Also, knowing the regulations and standards involved in medical and in vitro diagnostic devices is essential.
We will break down the most important international standards and regulations you need to know about to better understand how the CE marking process works.
Let’s have a look:
- Regulation (EU) 2017/745
- Regulation (EU) 2017/746
- Directive 2001/83/EC
- Regulation (EC) 726/2004
- Directive 2004/23/EC
- ISO 13485:2016
- ISO 14971:2019
- 21 CRF Part 820
Regulation (EU) 2017/745
The regulation EU 2017/745, also referred to as the Medical Devices Regulation or MDR, is a new regulation that replaces the previous Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD) entirely.
The official regulation describes all the mandatory procedures, transition arrangements, and explanations. If you are a medical device manufacturer, please always refer to this law for official information.
Although it was published in 2017, the requirements for placing medical devices on the European market only took effect on 26 May 2021.
Even so, transition arrangements allow some devices already on the market with MDD to remain available until 27 May 2025.
For example, if a company placed a medical device on the market in 2019, it could follow MDD or MDR. However, if the same company is to commercialize a new device in 2023, it must comply with MDR.
Recommended Reading: EU MDR Quality Management System [Role of an eQMS]
Regulation (EU) 2017/746
The regulation EU 2017/746, much like MDR, covers all documentation and processes regarding in vitro diagnostic devices and is known as In Vitro Diagnostic Regulation or IVDR.
The IVDR was also published recently, replacing Directive 98/79/EC and Commission Decision 2010/227/EU, and was implemented in May 2022.
It gave companies until 2026 to adapt to the new requirements.
Directive 2001/83/EC is related to medicinal products for human use, those present properties for treating or preventing disease.
However, when the substances in this directive are incorporated as an integral part of a device, their action becomes adjuvant.
In these occasions, the medical device needs to be in accordance with EU 2017/745.
A well-known example is drug-eluting stents in the treatment of coronary artery diseases. Coating the stent with a medicinal substance can reduce the incidence of complications, but the principal action is the stent itself.
If the action of those medicinal products is not secondary but principal, they must comply with Directive 2001/83/EC.
Regulation (EC) 726/2004
Regulation EC 726/2004 is related to medicinal products for humans and veterinary use, but 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 incorporating non-viable tissues or cells with a secondary action must comply with EU MDR.
EU MDR’s general safety and performance requirements must apply to the part of the device containing those substances, regardless of their principal activity.
ISO 13485:2016 standard specifies in detail the requirements for a QMS that manufacturers can use in one or more stages of the life cycle of a medical device.
Although there is no need to be accredited by this ISO to follow the regulation, companies often use this standard to comply with the requirement of a QMS present in MDR.
Having this standard established tends to cover all regulations concerning compliance with European laws, 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
Recommended Reading: ISO 13485 Quality Management System [Role of an eQMS]
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 and IVDR. However, manufacturers can achieve compliance without the need to be accredited by this ISO.
21 CRF Part 820
The 21 CRF Part 820 establishes good manufacturing practice requirements applicable to manufacturers of medical devices and sets forth quality system regulations.
It is the current QMS for medical devices used in the United States.
This code of regulation serves as a guideline for the QMS requirement of MDR but is not mandatory for CE marking. Most companies choose to follow ISO 13485:2016, though, as it can be accredited.
How To Obtain CE Marking for Medical Devices?
Obtaining a CE marking can be rather complex, but there is no need to be afraid.
Previously, we learned some of the standards and regulations a medical device company must follow to receive a CE marking.
As a result of meeting these requirements, a large volume of documentation needs to be correctly handled to place a legal device on the market.
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 aforementioned directives, standards, and regulations by providing a fully validated eQMS that helps companies manage quality throughout the product life cycle. In the next 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.
But now 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
- Prepare Supplier for Audits
- 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
- Implement a Post-Market Surveillance System
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 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 invasive and active 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
Introducing a medical device in the market generates lots of data and documents. Keeping track of all this information is vital to compliance.
Here is when ISO 13485:2016 gets into the picture.
The MDR says manufacturers must have quality and risk management systems, and ISO 13485:2016 covers both requirements at once.
Furthermore, 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 that proves conformity with the MDR.
A crucial document is the Design Control or Design Dossier, which contains information about a device’s physical characteristics and construction. It must prove the medical device was manufactured 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 for use in the languages accepted in the EEA
- Design and manufacturing information
- Information for the demonstration of conformity with the general safety and performance requirements
- Benefit-risk analysis and risk management
- Product verification and validation
- Post-market surveillance plan
A manufacturer must retain these documents for 10 to 15 years, depending on the device classification.
If that seems a lot to handle, know that SimplerQMS helps with the compilation of Technical Documentation.
Using our robust design controls and cloud-based storage, medical device manufacturers can make compliance with the MDR, more seamless.
5. Prepare Supplier for Audits
In accordance with the MDR, supplier companies can be audited by external organizations, known as Notified Bodies. The audits can be announced or unannounced.
Therefore, manufacturers must assist their suppliers in compliance with regulations to bring medical devices to market.
You can count on the SimplerQMS solution to assist you with your supplier management processes by providing a centralized repository for all your supplier information, scheduling supplier quality audits, 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.
For devices in classes IIb and III, manufacturers must also consult an expert panel.
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 to obtain the CE marking and, consequentially, a European representative to verify their documentation inside Europe.
8. Obtain Certification by a Notified Body
Notified Body is an independent organization responsible for auditing and certifying medical device manufacturers concerning the conformity of that device with MDR.
A list of valid Notified Bodies can be found in the New Approach Notified and Designated Organizations (NANDO) system.
Audits and assessments occur periodically every year to ensure companies are applying the approved QMS and post-market surveillance plan.
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.
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
Finally, it is time to place the CE marking on your medical device!
It must be affixed to the device itself, in the packaging, and in 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.
Concerning size, the marking must be at least 5 mm high. Only for small-scale devices can this be reduced. For larger sizes, manufacturers must follow the proportions laid out in MDR.
If applicable, the four-digit number of the Notified Body also needs to be printed alongside the CE marking.
12. Implement a Post-Market Surveillance System
After obtaining a CE marking and placing the devices into the EAA market, manufacturers need to keep collecting data regarding their medical 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.
Some of the obligations of manufacturers are:
- Follow-up complaints, adverse events, and non-conformity cases
- Update safety reports periodically
- Perform internal, and supplier audits routinely
- Keep technical documentation, databases, and registers updated
This surveillance ensures your medical device is always following the quality and safety requirements to comply with the MDR and is promptly ready to be re-certificated when needed.
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 CAPAs.
QMS software solution by SimplerQMS 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 addition, for manufacturers that wish to sell their medical devices in Great Britain (England, Scotland, and Wales), the CE marking is still valid until June 2023.
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 that 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.
How 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 on its own but imagine trying to manage them 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.
Also, keeping a significant number of files for up to 15 years 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 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 MDR establishes for your medical devices without compromising physical space.
Especially with the new 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 obtain and retain their CE Marking while satisfying the new requirements of MDR. The software solution automates and facilitates your quality management processes, saving valuable time and resources while helping you ensure compliance.
Plus, we provide a fully validated system and conduct continuous system re-validation, so you don’t have to spend any time and money on validation yourself. On top of that, we take full responsibility for our system software and are happy to participate with you during your audits when discussing our system.
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-certified. Usually, obtaining a CE mark 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.
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!