CE mark, CE marking for medical devices

This article describes when and why manufacturers must affix a CE mark, what is meant by CE marking, and what manufacturers must do up to that point.

1. Meaning of the CE mark

 

2. Requirements for CE marking

MDR and IVDR require the following from manufacturers regarding CE marking:

• Medical devices must be affixed with the CE marking permanently. (There are exceptions for custom-made devices and investigational devices).
• The CE mark must look as shown in Fig. 1 and be at least 5 mm high.
• If a notified body was involved in the conformity assessment procedure, its number must appear next to the CE mark (see Fig. 2).
• The medical devices must meet the requirements of the regulations (and other regulations and directives, if applicable) before the manufacturer may declare conformity and affix the CE marking.

3. Affixing the CE mark on software

Standalone software (websites, apps, or PC software) can also be a medical device. Therefore, these devices also require CE marking.

Manufacturers should affix the CE mark to standalone software, as far as is reasonable and possible, to or at:

• Start or splash screen.
• Help, About
• Website itself
• Accompanying materials, especially instructions for use, manual

There is no regulatory obligation to affix the CE mark in a web or app store.

4. The way to the CE mark

a) Overview of the phases

The whole process to obtain the CE mark includes several phases (see Fig. 3).

b) Start-up phase: Preparations for the CE mark

1. Intended purpose
   Formulate the intended purpose of your device. Specify exactly whether and how it is used to diagnose, treat, or monitor disease and injury, who the intended users are, and the intended context of use.
2. Regulatory requirements
   Determine which EU regulations affect your medical device (Medical Device Regulation MDR, IVD Regulation IVDR).
3. Classification
   If the MDR covers the device, use the classification rules in Annex VIII to determine which class your medical device belongs to (I, IIa, IIb, or III).We can assist you with this classification (contact us).
4. Choice of conformity assessment procedure
   Depending on the chosen class, you choose the conformity assessment procedure and may then have to establish a quality management system, which you must have certified according to ISO 13485.With our help, companies always succeed in doing this on the first try.

c) Development, test and production phase

1. General requirements
   Develop the medical device according to the requirements of your QM system, if one exists. In any case, it must comply with all basic requirements, e.g., the requirements for risk management, software life cycle processes, usability, and electrical safety.
   You prove this by complying with harmonized standards and documenting this with technical documentation.
   This Technical Documentation consequently contains:
   • Risk management file (compliant with ISO 14971)
   • Software file (compliant with IEC 62304)
   • Suitability for Usability-File (compliant with IEC 62366)
   • Electrical safety file (compliant with IEC 60601-1)
2. Clinical evaluation
   As part of the clinical evaluation, you demonstrate with clinical data that your medical device has no undesirable side effects and meets its intended benefit. Without reliable literature data, you must conduct a clinical investigation.
3. Production
   Finally, you produce, i.e., reproduce your medical devic.

d) Release phase including CE marking

1. Declaration of conformity
   Declare the conformity of your device with the general requirements. To do this, draw up a declaration of conformity and affix the CE mark to your device.
2. Registration
   Register yourself and your medical device with EUDAMED or BfARM.
3. Market release
   Finally, issue the market release and place your device on the market – with the CE mark.

e) Post-market phase

The final phase continues as long as at least one of your devices is on the market. In this phase, you continuously review feedback from the “field,” respond to incidents, and update your risk management files.

5. Conclusion and summary

Affixing the CE mark is one of the more manageable tasks that manufacturers must master to bring their medical devices onto the market in compliance with the law and to be allowed to keep them there. The tricky part is to create the conditions for this, i.e., to prove conformity. Nevertheless, this CE marking must also meet the statutory requirements.

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Change history

• 2023-08-22: Editorial changes only (including spelling errors removed).
• 2023-05-04: Article fundamentally revised, requirements of the MDR described in more detail.
• 2019-06-17: First version of the article