The CE Mark logo is a critical symbol for manufacturers and distributors who want to place their products in the European Economic Area (EEA). It acts as a declaration by the manufacturer that the product meets the essential requirements set by EU regulations related to health, safety, and environmental protection.
For industries like medical devices and in vitro diagnostic (IVD) products, CE marking is not optional — it’s a legal requirement under the EU MDR (Medical Device Regulation 2017/745) and IVDR (In Vitro Diagnostic Regulation 2017/746). Affixing the CE mark confirms that the product has successfully undergone the necessary conformity assessment procedures and can be marketed across Europe without additional national approvals.
Before a medical device or IVD can bear the CE logo, manufacturers must demonstrate compliance in three critical areas:
These performance evaluations form the foundation of the technical documentation required for CE marking.
Once the CE logo is affixed to a product, it communicates that the product is:
For importers and exporters, especially those selling products manufactured outside the EU, affixing the CE mark is essential. Without it, the product cannot be legally placed on the European market.
The CE logo must be:
If direct marking on the device isn’t technically possible or appropriate due to size or material limitations, alternate placements are allowed—but they must still comply with Article 20 of MDR/IVDR.
The CE mark has strict design specifications. Modifying or misrepresenting the logo is not permitted.
These design rules are outlined in the EU Blue Guide, which provides best practices for placing products on the EU market.
For medical device companies, CE marking is not just a legal requirement – it provides strategic advantages:
By meeting CE marking standards, companies align with the Global Harmonization Task Force (GHTF) principles and make future entry into other regulated markets easier (e.g., UKCA, FDA, TGA).
The CE mark logo is much more than a visual stamp. For medical device and IVD companies, it’s a critical indicator that the product complies with EU regulatory expectations, can be trusted by healthcare professionals, and is ready for the European market.
Whether you’re a startup launching your first diagnostic product or an established manufacturer updating your device to align with IVDR/MDR, getting the CE logo right is a vital step in your compliance journey.
At Maven Profcon Services LLP, we specialize in guiding manufacturers through every step of the CE marking process—from risk classification and technical documentation to performance evaluation and regulatory strategy.
To affix the CE mark, it must be placed visibly, legibly, and indelibly on the product, its packaging, or accompanying documentation. The minimum size of the CE logo must be 5 mm in height, and the logo must not be altered in shape or proportion.
For in vitro diagnostic devices (IVDs), the CE mark requirements are defined under the IVDR (2017/746). Manufacturers must demonstrate scientific validity, analytical performance, and clinical performance, and compile full technical documentation before affixing the CE logo.
Yes. All medical devices marketed in the EU must bear the CE mark. Depending on the device classification (Class I, IIa, IIb, III), manufacturers may need to involve a Notified Body in the CE conformity assessment process.
Products with an incorrect or missing CE logo may be banned from entering the EU market. Authorities may impose penalties, issue recalls, or block distribution. It’s essential to follow proper CE mark placement guidelines and regulatory steps.
Recent Post
Are You Looking For Medical Devices Certifications?
Contact Us