What is the primary objective of **CE Marking**?

**The primary objective of CE Marking is to indicate the manufacturer’s declaration that a product meets applicable EU harmonisation legislation essential requirements for health, safety, environmental protection, and free movement across the EEA.** It enables products covered by specific directives or regulations—such as Low Voltage Directive 2014/35/EU (50–1000 V AC, 75–1500 V DC)—to be marketed freely without further national approvals, provided conformity assessment is completed and technical documentation retained.

Who is legally or professionally required to comply with **CE Marking**?

**Manufacturers, importers, distributors, and authorised representatives are legally required to comply with CE Marking for products falling under harmonised EU legislation.** The manufacturer—who makes or brands the product—bears primary responsibility for conformity assessment, technical file, EU Declaration of Conformity (DoC), and affixing the mark; non-EU manufacturers must appoint an EU authorised representative since 16 July 2021 for market surveillance contact.

Oes **CE Marking** require an external audit or third-party certification?

**CE Marking does not universally require external audit or third-party certification; it depends on the product risk and applicable legislation, with many allowing manufacturer self-assessment.** For low-risk products like those under Low Voltage Directive 2014/35/EU, manufacturers alone perform conformity assessment (e.g., Module A: internal production control); higher-risk categories mandate Notified Body involvement via modules B–H, verifiable in the NANDO database.

How often should an assessment for **CE Marking** be performed?

**CE Marking conformity assessment is performed prior to placing the product on the market and updated for significant changes, with ongoing production controls and post-market surveillance required indefinitely.** Technical documentation must be retained for at least 10 years after market placement, and re-assessment triggered by design variants, firmware updates, or OJEU harmonised standards changes (e.g., Implementing Decision (EU) 2023/2723).

What are the consequences of non-compliance with **CE Marking**?

**Non-compliance with CE Marking results in market withdrawal, product recalls, sales bans, fines, and customs seizures enforced by national authorities under Regulation (EU) 2019/1020.** Authorities may demand technical files, test products, and impose corrective actions; unauthorised marking on out-of-scope products is prohibited, leading to legal liability for manufacturers and economic operators.

An **CE Marking** be mapped to other international frameworks?

**CE Marking cannot be directly mapped to other international frameworks as it is specific to EU harmonisation legislation and provides no automatic equivalence.** While harmonised standards (OJEU-published) may align with global norms, presumption of conformity is exclusive to EU rules; voluntary certificates from non-Notified Bodies hold no legal value for EU market surveillance or customs.

What is the first step to begin implementing **CE Marking**?

**The first step to implement CE Marking is to identify all applicable EU harmonisation legislation and confirm product scope via official lists on Your Europe or sector pages.** Determine essential requirements, conformity modules, and Notified Body needs; products not covered must not bear the mark, avoiding illegal application.

What is the primary objective of **MLPS 2.0 (Multi-Level Protection Scheme)**?

**The primary objective of MLPS 2.0 is to classify information systems into five protection levels based on potential harm to national security, social order, and public interests, ensuring commensurate technical, management, and governance controls.** Originating from China's 2017 Cybersecurity Law Article 21, MLPS 2.0 mandates network operators to implement graded protections across physical security, network boundaries, data protection, and security operations, with extensions for cloud, IoT, big data, and industrial controls. This establishes a nationwide cybersecurity baseline enforced by Public Security Bureaus.

Who is legally or professionally required to comply with **MLPS 2.0 (Multi-Level Protection Scheme)**?

**All network operators in mainland China, including domestic firms, foreign-invested enterprises, and multinationals with local systems, must comply with MLPS 2.0.** This encompasses operators of IT networks, cloud platforms, IoT, big data, and industrial systems, particularly in critical sectors like energy, finance, telecom, and healthcare. Virtually no exemptions apply; systems at Level 2+ require PSB filing and approval.

Does **MLPS 2.0 (Multi-Level Protection Scheme)** require an external audit or third-party certification?

**Yes, MLPS 2.0 requires external security reviews by licensed Chinese firms for Level 2 and above systems, with PSB approval and a minimum passing score of 75/100.** These audits assess technical controls, governance, documentation, and architecture; Level 3+ demands annual evaluations, while Level 1 relies on self-assessment.

How often should an assessment for **MLPS 2.0 (Multi-Level Protection Scheme)** be performed?

**Assessments under MLPS 2.0 must occur biennially for Level 2, annually for Level 3, semi-annually for Level 4, and as mandated for Level 5, plus after major changes.** Self-inspections are required continuously, with third-party evaluations and PSB re-evaluations ensuring ongoing compliance.

What are the consequences of non-compliance with **MLPS 2.0 (Multi-Level Protection Scheme)**?

**Non-compliance with MLPS 2.0 results in fines up to 100,000 yuan, operational suspensions, system shutdowns, and intensified PSB inspections.** Enforcement links certification to business license renewals; severe cases in critical sectors have yielded fines exceeding RMB 200 million, plus reputational damage and license revocation risks.

An **MLPS 2.0 (Multi-Level Protection Scheme)** be mapped to other international frameworks?

**Yes, MLPS 2.0 control domains—governance, physical, technical, and personnel—map to frameworks like ISO 27001 Annex A and NIST CSF.** Organizations leverage existing ISMS Statements of Applicability for gap analysis, though MLPS adds prescriptive baselines, PSB oversight, and data localization unique to Chinese law.

CE Marking vs MLPS 2.0 (Multi-Level Protection Scheme)

Standards Comparison

CE Marking

Mandatory

1985

EU marking for product conformity and market access

MLPS 2.0 (Multi-Level Protection Scheme)

Mandatory

N/A

China's regulation for graded cybersecurity protection of networks.

Quick Verdict

CE Marking declares EU product safety compliance for free market access, while MLPS 2.0 mandates graded cybersecurity in China with PSB oversight. Companies adopt CE for EEA sales, MLPS for legal operations in China.

Product Safety

CE Marking

CE Marking (Conformité Européenne)

Cost

€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Manufacturer self-declares conformity to EU essential requirements
Enables free product circulation across EEA markets
Harmonised standards provide OJEU presumption of conformity
Risk-proportionate conformity assessment modules A-H
Mandates technical file and DoC 10-year retention

Standard

MLPS 2.0 (Multi-Level Protection Scheme)

Multi-Level Protection Scheme 2.0

Cost

€€€€

Complexity

Medium

Implementation Time

12-18 months

Key Features

Five-level impact-based system classification
Mandatory for all China network operators
Technical, governance, physical controls baseline
Third-party audits and PSB approval Level 2+
Enforced by Public Security Bureaus

Detailed Analysis

A comprehensive look at the specific requirements, scope, and impact of each standard.

CE Marking Details

What It Is

CE Marking (Conformité Européenne) is the EU's compliance marking framework under the New Legislative Framework (NLF). It signifies a manufacturer's declaration that products meet essential health, safety, and environmental requirements in harmonised legislation like LVD, Machinery Directive, and RED. Scope covers electrical equipment, toys, PPE, and more; approach is risk-based via conformity assessment modules.

Key Components

Applicable directives/regulations identification
Conformity modules (A-H: self-assessment to full quality assurance)
Technical documentation (design, tests, risks)
EU Declaration of Conformity (DoC)
CE mark affixing with Notified Body ID if required Built on OJEU harmonised standards for presumption of conformity; self-declaration or third-party model.

Why Organizations Use It

Mandated for EEA market access; enables free movement, reduces country barriers. Manages compliance risks, limits liability, boosts tender competitiveness, builds stakeholder trust.

Implementation Overview

Map legislation, perform risk assessment, compile technical file, issue DoC, affix mark, ensure post-market surveillance. Applies to manufacturers/importers in EEA; no central certification—authority audits on request.

MLPS 2.0 (Multi-Level Protection Scheme) Details

What It Is

MLPS 2.0 (Multi-Level Protection Scheme 2.0) is China's mandatory cybersecurity regulation under the 2016 Cybersecurity Law. It classifies information systems into five levels based on potential harm to national security, social order, and public interests, requiring graded technical, organizational, and governance controls.

Key Components

Core domains: physical security, network protection, data security, access control, monitoring, and governance.
Standards like GB/T 22239-2019 define baselines; extended for cloud, IoT, big data.
Common controls for all levels plus level-specific requirements.
Compliance via self-classification, third-party audits (Level 2+), PSB approval.

Why Organizations Use It

Legally required for China network operators to avoid fines, suspensions.
Enhances resilience, supports market access, aligns with data laws.
Builds regulator trust, reduces breach risks.

Implementation Overview

Phased: scoping, classification, gap analysis, remediation, audits, ongoing monitoring.
Applies to all sizes in China; critical for multinationals.
Mandatory PSB filings, periodic re-evaluations. (178 words)

Key Differences

Aspect	CE Marking	MLPS 2.0 (Multi-Level Protection Scheme)
Scope	Product safety, health, environmental compliance	Graded cybersecurity for networks, information systems
Industry	Manufacturers across EU/EEA product sectors	All network operators in mainland China
Nature	Manufacturer self-declaration, market access marking	Mandatory classification, PSB enforcement regulation
Testing	Self-assessment or notified body modules as needed	Third-party audits, PSB review for Level 2+ systems
Penalties	Market withdrawal, fines by national authorities	Fines, operational suspension, license revocation