Certification Introduction

The CE marking is a mandatory compliance access mark for medical devices to enter the EU market. All medical devices placed on the EU market must complete conformity assessment and affix the CE marking before they can be launched and circulated. This marking proves that the product meets the basic requirements of health, safety and performance stipulated by EU regulations, and the manufacturer shall bear full responsibility for product compliance. Devices with different risk levels correspond to different certification paths: low-risk devices can achieve compliance through self-declaration, while high-risk devices require participation of an EU Notified Body for assessment.

Laws and Regulations

The core regulations for EU medical device supervision are Regulation (EU) 2017/745 (EU Medical Device Regulation, abbreviated as MDR) and Regulation (EU) 2017/746 (EU In Vitro Diagnostic Medical Device Regulation, abbreviated as IVDR), which have fully replaced the old MDD/IVDD directives. Starting from May 28, 2026, the four modules of the EUDAMED database will be fully enforced, with no transition period exemption.

Technical Requirements

Classified by risk level, general medical devices (MD) are divided into Classes I, IIa, IIb, and III, while in vitro diagnostic devices (IVD) are divided into Classes A, B, C, and D. Different risk levels correspond to differentiated certification requirements. A quality management system compliant with the ISO 13485 standard must be established and operated to implement quality control throughout the entire product life cycle. Complete technical documents must be submitted, including risk management report, biocompatibility evaluation, clinical evaluation/performance evaluation report. High-risk products are required to provide complete clinical trial data. Unique Device Identification (UDI) is mandatory, to achieve full-chain traceability of products from production to circulation. A post-market surveillance system must be established, periodic safety update reports shall be submitted as required by regulations, and technical documents must be retained for at least 10 to 15 years.

Certification Process

Confirm product risk classification, clarify the applicable MDR or IVDR regulation and the corresponding conformity assessment path;

Appoint a qualified EU Authorized Representative (EC REP) and sign a formal authorization agreement;

Complete enterprise registration on EUDAMED and obtain the unique registration code SRN;

For products requiring Notified Body intervention, confirm and sign a contract with a qualified EU Notified Body (NB);

Prepare product technical documents, establish and operate a quality management system that meets the requirements;

For general Class I devices and IVD non-sterile Class A products, compliance can be completed through manufacturer's self-declaration;

For MD Class I sterile/measuring/reusable devices, IVD sterile Class A devices, and other medium and high-risk products, products shall be submitted to the Notified Body for conformity audit;

After passing the audit and obtaining the CE certificate, complete UDI data declaration and device information entry in EUDAMED;

After affixing the CE marking on the product in accordance with regulatory requirements, the product can be legally placed on the EU market. The certificate is valid for 5 years, and manufacturers must continuously fulfill obligations such as post-market adverse event reporting and registration document update.

WANVE provides one-stop full compliance support for enterprise export.