Certification Introduction
CE marking is a mandatory compliance access mark for medical devices entering the EU market. All medical devices placed on the EU market must complete compliance certification and affix the CE marking. Starting from 2026, the EU will fully implement digital regulation, and the EUDAMED medical device database will be mandatory. Products that have not completed registration will be prohibited from customs clearance and market launch. EU member states uniformly implement regional regulations, with only minor differences at the implementation level, and overall rule alignment is high.
Laws and Regulations
The core regulations are two currently effective EU regulations: General medical devices are subject to the EU Medical Device Regulation (EU) 2017/745 (abbreviated as MDR), and in vitro diagnostic medical devices are subject to the EU In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (abbreviated as IVDR). These two regulations have fully replaced the old MDD/IVDD directives. Starting from May 28, 2026, four core modules of the EUDAMED system including enterprise registration and UDI declaration will be fully mandatory, with no transition period exemption. The UK is not part of the EU customs territory, newly launched medical devices require separate UKCA certification, and original CE certificates can be used until June 30, 2026.
Technical Requirements
- Classified by risk level, MDR divides devices into Classes I, IIa, IIb, III, and IVDR divides devices into Classes A, B, C, D. Different risk levels correspond to differentiated certification requirements
- The quality management system must comply with ISO 13485 standard, covering full life cycle control of products
- Complete technical documentation must be provided, including risk management report, biocompatibility evaluation, clinical evaluation/performance evaluation report; high-risk products need to provide complete clinical trial data
- Unique Device Identification (UDI) is mandatory to achieve full-chain traceability
- A post-market surveillance system must be established, periodic safety update reports shall be submitted as required, and technical documents must be retained for at least 10 to 15 years
Certification Process
- Confirm product risk classification and clarify whether MDR or IVDR regulation applies
- Compile product technical documents and establish a quality management system that meets requirements
- Low-risk Class I/A products can issue a self-declaration of compliance; medium and high-risk products must be submitted to an EU Notified Body for conformity assessment
- After passing the audit and obtaining the CE certificate, complete EUDAMED enterprise SRN registration, product UDI and information declaration
- Affix the CE marking to the product per requirements, and the product can then be legally placed on the EU market
WANVE, as a professional technical service organization, provides one-stop full compliance support for enterprise export.