Drugdu.com expert's response:

The validity period of a CE certification certificate typically ranges from 1 to 10 years, with the specific duration depending on factors such as the product's risk level, regulatory updates, and design modifications. Below is a detailed summary of the validity period of CE certification certificates:

I. Validity Period Based on Product Risk Level

Low-Risk Products: For products such as ordinary toys and general machinery, CE certificates usually have a validity period of 5 years. These products have relatively stable technical standards and lower safety risks, prompting certification bodies to issue long-term valid certificates.

Medium-Risk Products: For products like construction products and personal protective equipment, CE certificates generally have a validity period of 3 years. These products require regular reviews of design documentation and production consistency to ensure compliance with new EU standards.

High-Risk Products: For products such as implantable medical devices, dangerous machinery, boilers, pressure vessels, and elevators, CE certificates may have a shorter validity period and require annual supervisory audits to maintain their validity. Some high-risk products can have CE certificates valid for up to 10 years, but manufacturers must undergo annual supervisory audits to confirm the continued effectiveness of their quality management systems (e.g., ISO 13485).

II. Impact of Regulatory Updates on Validity Period

CE certification is based on EU directives (such as RED and MDR). If relevant standards are revised (e.g., updates to EN standards), the original certificate may immediately become invalid and require re-evaluation. For instance, after the Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD), the original certificates needed to be updated within a transitional period.

Each regulatory update comes with a buffer period. After this period, certificates and reports issued under the old regulations will expire.

III. Impact of Product Changes on Validity Period

If there are significant changes to the product's structure, materials, or functionality, even if the certificate is still within its validity period, re-certification is required. For example, adding an electronic module to a toy may result in changes to EMC testing requirements.

When replacing key suppliers or relocating production facilities, the consistency of the production process must be re-evaluated, potentially triggering a certification update.

IV. Common Scenarios for Certificate Expiration

Failure to Pass Annual Supervisory Audits: This applies to high-risk products that require annual audits.

Unauthorized Modification of Product Parameters by the Manufacturer Without Resubmission for Inspection.

Non-Compliance Found During EU Market Inspections: For instance, safety issues reported by the German GSG or the Dutch NVWA.