2026 EU CE compliance is undergoing a dual transformation driven by "digital mandatory requirements + regulatory implementation". On one hand, the EUDAMED database will be mandatory in May, entering an era of "full-process traceability" for medical device compliance. On the other hand, the MDR/IVDR revision proposal advances, new battery regulation details take effect, and UKCA transition policies are refined — shifting compliance logic from "passive response" to "proactive adaptation".

I. Clarify First: Three Core Compliance Insights for 2026 (Correcting Market Misinterpretations)

1.Insight 1: EUDAMED Mandate ≠ Only UDI Registration — Starting May 28, 2026, the first four modules will be fully implemented, focusing on the full chain of "SRN registration + UDI filing + certificate upload + economic operator information entry". Completing only UDI coding without an SRN number will still prevent legal market access. A Jiangsu medical enterprise delayed its Q1 new product launch by 45 days due to neglecting SRN registration.

2.Insight 2: Extended UKCA Grace Period for CE Medical Devices — The CE mark is not fully banned in the UK from January 2026. The UK government clarifies: CE medical devices complying with EU MDR/IVDR can be sold in Great Britain until June 30, 2030; MDD/AIMDD-compliant products until June 30, 2028. Only newly launched products need priority UKCA adaptation.

3.Insight 3: MDR/IVDR Revision Proposal ≠ Immediate Cost Reduction — The December-released proposal is in the legislative consultation phase, requiring review by the European Parliament and Council. It is expected to take effect in 2026 or later. Currently, medical devices must still comply with existing MDR/IVDR — do not prematurely relax clinical data requirements.

II. Core 2026 EU CE Conformity Certification Transformations

2026 EU CE compliance centers on "regulatory closure + digital penetration". Four transformations directly determine customs clearance efficiency, with EUDAMED implementation as the top priority:

(I) Digital Compliance: Mandatory EUDAMED Database Implementation (Deadline: May 28, 2026)

This is the "lifeline" for 2026 medical device compliance. The EU achieves full-chain traceability through the database — unregistered products will be directly seized:

1. Mandatory Modules and Requirements

·Module 1 (Actor Registration): Manufacturers, Authorized Representatives (EC REP), and importers must complete Single Registration Number (SRN) registration. Information changes must be updated within 24 hours to avoid "compliance anomalies" due to outdated contact details.

·Module 2 (UDI/Device Registration): All medical devices must submit UDI codes and product information. Implantable devices require additional details such as implantation site and validity period — UDI codes must comply with the GS1 standard.

·Module 3 (Certificates): NBs must upload certificates to the database within 7 working days of issuance. Enterprises can query certificate status via their SRN to avoid "fake certificates".

·Module 4 (Vigilance): Adverse event reports must be synchronously entered into the database, with reporting deadlines shortened to 24 hours for serious adverse events — extending the traceability chain.

2. Practical Reminder: Initiate registration 60 days in advance. Select an EC REP familiar with EUDAMED operations. A Zhejiang in vitro diagnostic enterprise spent 30 days revising application materials due to errors, narrowly missing the deadline.

(II) MDR/IVDR Revision Proposal: Cost Reduction Direction in Legislative Process (Expected to Take Effect in 2026 or Later)

Based on the 170-page proposal released by the European Commission on December 16 (JD Supra interpretation, January 2026), future compliance will show a "risk-classified simplification" trend — enterprises can anticipate adjustments:

1. Core Adjustments (Industry Estimates Based on Proposal Direction)

·Risk Class Downgrade: Reusable surgical instruments and some Class IIb in vitro diagnostic reagents will have reduced risk classes, no longer requiring full NB review — compliance costs expected to decrease by 20%-30%.

·Clinical Data Optimization: Computer simulation testing and real-world data can replace some physical clinical tests — eliminating high clinical costs for SMEs.

·Simplified Audit Model: For series Class IIa/IIb devices, "representative product sampling" is allowed; other variants only require difference statements, no full-series testing.

2. Note: Current regulations still apply. A 6-month transition period will follow proposal implementation — retain existing compliance processes to avoid illegal adjustments.

(III) New Battery Regulation Details Implementation (Enhanced Enforcement Starting August 2026)

The new Battery Regulation (EU) 2023/1542, effective August 2025, enters an enhanced implementation phase in 2026, focusing on carbon footprint and traceability:

1. New Requirements

·Carbon Footprint Declaration: Must include full-chain data from "raw material extraction to production and transportation", with verification reports issued by EU-recognized institutions. The proposed carbon footprint limit for energy storage batteries is 100kg CO₂eq/kWh (industry estimate).

·Starting August 2026: Portable and industrial batteries must bear QR codes labeling recycling information and carbon footprint grades — unlabeled products will fail customs inspections.

2. Forward Preparation: Lay the groundwork for the "Battery Passport" electronic traceability system (to be launched in 2027 and beyond) by organizing battery supply chain data and establishing raw material traceability accounts.

(IV) Digital Upgrade of Technical Documentation and DoC (Fully Enhanced in 2026)

The EU customs AI inspection system has been upgraded — technical documentation and DoC are core inspection targets. New requirements directly impact customs clearance:

1.Technical Documentation: Retain for 10 years for ordinary products; for implantable devices, retain for at least 15 years after the last product is placed on the market (per MDR Art.10). All documents must be synchronously uploaded to internal digital systems to support EU regulatory online verification.

2.DoC Declaration: Must include "product full-lifecycle traceability information + EUDAMED registration number (for medical devices)". The QR code must link to test reports and NB information for one-click verification. Inconsistent information will be penalized as "false declarations", with fines up to 4% of annual sales.

III. 2026 Compliance Guidelines by Product Category

Different categories require targeted responses to new requirements to avoid "unnecessary testing" or "seizure due to missing tests". Focus on special adjustments for medical devices and battery products:

1. Medical Devices and In Vitro Diagnostic Reagents

·Core Directives: MDR 2017/745, IVDR 2017/746 — full NB review still required for Class III devices.

·2026 Focus: Complete full-module EUDAMED registration by May 28; retain complete clinical data (current requirements still apply despite proposal simplifications); EC REP information must match EUDAMED registration — no arbitrary replacements.

·Pitfalls: UDI codes must fully align with product packaging and technical documentation. A blood glucose meter enterprise was notified by the EU RAPEX system due to incorrect UDI code length, resulting in an $8 million recall loss.

2. Electrical/Electronic and Battery Products (Home Appliances, Energy Storage Devices, Power Banks)

·Core Directives: EMC + LVD + RoHS 3.0; wireless products add the RED Directive; battery products comply with the new Battery Regulation.

·2026 Focus: Energy storage batteries require carbon footprint verification; 5G devices undergo 5.8GHz DFS dynamic frequency selection testing; lithium batteries pass EN 62133-2 thermal abuse testing to prevent overcharge fires.

·Pitfalls: Carbon footprint reports must be issued by EU-recognized institutions. Third-party laboratory reports require ILAC mutual recognition marks — otherwise, customs will reject them.

3. Machinery and Children’s Products (Industrial Machinery, Children’s Clothing, Toys)

·Core Directives: Machinery products use the Machinery Directive (NB involvement required for hazardous machinery); children’s products use the Toy Safety Directive (comply with EN 71 series standards).

·2026 Focus: Connected machinery completes cybersecurity risk assessments (refer to EN 303 645:2022); emergency stop systems meet ISO 13485 PL d certification; children’s clothing has formaldehyde content ≤20mg/kg; toys add 5 new SVHC substances — advance chemical testing required.

·Pitfalls: Hazardous machinery "risk assessment reports" require NB review and signature — self-declaration is invalid. A woodworking machinery enterprise faced a 30-day delay in re-review due to missing signatures, resulting in seized goods.

IV. Institution Selection and Cost Optimization: Compliance on a Budget in 2026

CE certification costs vary significantly by product risk level and test items. Optimize costs in 2026 through precise institution selection and leveraging policy dividends:

·Low-Risk Products (ordinary toys, non-connected small appliances): 1,800-6,500 yuan (approximately $258-$935) — self-declaration allowed. Prioritize ILAC-accredited domestic laboratories for basic safety and chemical testing to save costs.

·Medium-Risk Products (wireless earbuds, ordinary machinery): 4,500-28,000 yuan (approximately $645-$4,015) — multi-directive testing. Reduce costs by 20%-30% through "representative product sampling" for series products. For medical devices, engage NBs familiar with EUDAMED registration (e.g., BSI, DEKRA) in advance.

·High-Risk Products (Class III medical devices, energy storage systems): 35,000-1,500,000 yuan (approximately $5,025-$215,000+) — medical devices require additional EUDAMED registration service fees (approximately 5,000-10,000 yuan/$715-$1,430); energy storage systems require carbon footprint verification fees (approximately 20,000-50,000 yuan/$2,875-$7,185).

Key factors for selecting an institution:

1.Qualification Alignment: Choose NBs offering EUDAMED registration guidance for medical devices and institutions with carbon footprint verification qualifications for battery products — avoid missing test items.

2.Regulatory Tracking Capability: Prioritize institutions that synchronously interpret the MDR/IVDR revision proposal and provide timely regulatory update reminders to ensure long-term product compliance.

3.Service Efficiency: Institutions supporting remote audits and online document submission are more efficient, saving on-site audit travel costs. Confirm post-sales includes technical document correction guidance.

2026 EU CE compliance is no longer a "one-time certification success" but a systematic project of "digital registration first, regulatory rhythm tracking, and detailed control". The mandatory implementation of EUDAMED is just the starting point for digital compliance. Subsequent MDR/IVDR revisions and Battery Passport launches require enterprises to establish a "regular compliance" mechanism.

Compliance essentially reduces operational risks — 2026 EU regulation will only become more precise and strict. Rather than passively responding to inspections, proactively prepare in advance to gain a competitive edge in the global market with true compliance.

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