How do I affix the CE mark correctly on my product?

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.

What are the CE mark requirements for IVDs?

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.

Is CE marking mandatory for all medical devices in the EU?

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.

What happens if my product has an incorrect CE logo or no CE marking?

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.