How to Verify a Chinese Supplier’s Pressotherapy Machine CE Certification for EU MDR?

When our production team ships pressotherapy machines to European distributors, we face a constant challenge EU Declaration of Conformity ¹. Buyers need proof that our CE certificates ² are real. Fake certificates flood the market. One counterfeit document can stop your shipment at customs and destroy your business reputation.

To verify a Chinese supplier’s pressotherapy machine CE certification, cross-reference the Notified Body number on the NANDO database, request complete technical documentation per MDR Annex II, check EUDAMED registration status, examine the EU Declaration of Conformity for required elements, and confirm the supplier has appointed a legitimate EU Authorized Representative.

This guide walks you through each verification step. You will learn how to spot fake certificates, which documents to demand, and how to use official EU databases. Let us start with the basics of certificate authentication.

How can I verify that my Chinese supplier's pressotherapy machine CE certificate is authentic and not forged?

Our quality assurance team encounters forged certificates more often than you might expect. Some suppliers create fake Notified Body logos. Others copy certificate numbers from legitimate companies. The financial and legal consequences of importing devices with fraudulent certifications can be severe.

Verify a CE certificate's authenticity by first checking the four-digit Notified Body number against the EU's official NANDO database. Then contact the Notified Body directly with the certificate number and manufacturer details. Cross-reference all information with the supplier's technical documentation and EU Declaration of Conformity.

Understanding What Makes a CE Certificate Legitimate

A legitimate CE certificate for Class IIa or IIb pressotherapy machines must come from an EU-designated Notified Body. A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements.

In the case of medical devices which present risk factors, certification by a Notified Body is required. Pressotherapy machines typically fall into Class IIa or IIb due to their active nature and intended therapeutic use. This means self-certification is not permitted.

The NANDO Database: Your First Verification Tool

The NANDO Database ³ (New Approach Notified and Designated Organisations) is the official European Commission platform listing all Notified and Designated Bodies authorised to perform conformity assessments under EU legislation.

The NANDO database is publicly accessible via the European Commission portal and can be searched: By country, to view all Notified Bodies in a Member State; By legislation, e.g. Regulation (EU) 2017/745 ⁴ for medical devices; By name or ID number, to check the current status of a specific body.

Step-by-Step Certificate Verification Process

The database can be used to verify the status (valid/withdrawn/expired/suspended) of a notified body related to a particular European Directive or Regulation as well as the associated designated scope of tasks related to conformity assessment procedures set out in that Directive or Regulation.

Common Forgery Patterns to Watch For

From our experience working with European importers, these patterns indicate potential fraud:

• Certificate numbers that cannot be verified with the Notified Body
• Notified Body logos that do not match official versions
• Certificates issued by bodies not designated for MDR 2017/745
• Missing or incorrect manufacturer registration details
• Certificates with grammatical errors or formatting inconsistencies

For manufacturers seeking to work with a Notified Body, NANDO serves as a verification tool. Manufacturers can confirm whether a specific Notified Body is officially designated and whether its designation covers the type of products they manufacture.

Does my manufacturer's current certification actually meet the latest EU MDR requirements for medical beauty devices?

We transitioned our quality management system to meet MDR requirements years ago. However, many suppliers still operate under the old Medical Device Directive ⁶ framework. This creates significant compliance risks for importers who assume any CE certificate means MDR compliance.

EU MDR 2017/745 replaced the old Medical Device Directive (MDD) with stricter requirements including enhanced clinical evidence, post-market surveillance, EUDAMED registration, and Person Responsible for Regulatory Compliance (PRRC) appointment. Certificates issued under MDD are being phased out with specific deadlines based on device risk classification.

The Fundamental Shift from MDD to MDR

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).

Changes compared to the Medical Device Directive include changes in device classification and device scope, stricter oversight of manufacturers by notified bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC) and of the economic operator concept, the requirement of Unique Device Identification marking for devices, EUDAMED registration ⁷, UDI requirements, and increased postmarketing surveillance activities.

Key MDR Requirements Your Supplier Must Meet

Understanding Transition Period Deadlines

As of 2025, the MDR is fully applicable, supported by ongoing MDCG guidance, gradual rollout of EUDAMED modules, and transitional arrangements extended under Regulation (EU) 2023/607 to avoid shortages in essential medical devices.

Many devices previously Class I under the MDD are now IIa or IIb, triggering Notified Body involvement for the first time. This is particularly relevant for pressotherapy machines, which may have been reclassified under MDR's expanded 22 classification rules.

Verifying MDR Compliance Status

When reviewing your supplier's certification, look for these MDR-specific indicators:

1. Certificate Reference: Must cite Regulation (EU) 2017/745, not Directive 93/42/EEC
2. PRRC Documentation: Supplier should identify their Person Responsible for Regulatory Compliance
3. UDI Assignment: Devices must have Unique Device Identifiers assigned
4. Clinical Evaluation Report: Must follow MDR Article 61 requirements
5. Post-Market Surveillance Plan: Must comply with MDR Annex II ⁸I

Manufacturers must appoint a Person Responsible for Regulatory Compliance (PRRC) (Article 15), maintain a Quality Management System (Article 10) aligned with ISO 13485:2016, conduct continuous Post-Market Clinical Follow-Up (PMCF), maintain fully traceable technical documentation throughout the device lifecycle.

What specific technical documents should I request from my supplier to guarantee my shipment passes EU customs?

Our documentation team maintains comprehensive technical files for every pressotherapy model we manufacture. European customs authorities can request these documents at any time. Missing or incomplete documentation results in shipment delays and potential seizure.

Request complete MDR Annex II technical documentation including device description and classification rationale, design and manufacturing information, General Safety and Performance Requirements (GSPR) checklist, risk management file per ISO 14971, clinical evaluation report, labeling and IFU, and post-market surveillance plan. Also obtain the EU Declaration of Conformity, valid CE certificate, and EC REP authorization.

The Technical Documentation Structure Under MDR

Annex II of the MDR describes which components a technical documentation should contain.

The requirement to draw up technical documentation can be found primarily in Article 10(4), which states: Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III.

Complete Document Checklist for Importers

Critical Documents for Customs Clearance

The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements.

Request these documents as priority items:

1. EU Declaration of Conformity (DoC): The legally binding statement that the device meets EU requirements
2. CE Certificate: Issued by the Notified Body for Class IIa/IIb devices
3. Technical File Summary: Overview document referencing full documentation location
4. Clinical Evaluation Report (CER): Evidence of clinical safety and performance
5. EC REP Authorization Letter: Proof that an EU Authorized Representative ¹⁰ is appointed

Design and Manufacturing Documentation Details

Information to allow the design stages applied to the device to be understood; complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the technical documentation; identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed.

Post-Market Surveillance Documentation

According to the MDR, a manufacturer must systematically monitor his medical device after it has been placed on the market. The results flow directly into the technical documentation, which he updates accordingly (Annex III MDR).

Your supplier should provide:

• Post-Market Surveillance (PMS) Plan
• Post-Market Clinical Follow-up (PMCF) Plan
• Previous PMS Reports (if device has market history)
• Vigilance procedures and incident reporting protocols

How do I use the notified body's database to confirm my supplier's CE registration is still valid?

When we receive inquiries from European buyers, they often ask for verification methods beyond simply seeing a certificate. Smart importers use multiple databases to cross-reference supplier claims. The EUDAMED system is becoming the central verification tool for medical device compliance.

Use the NANDO database to verify Notified Body designation status, then check the Notified Body's own certificate database using the certificate number. From May 28, 2026, EUDAMED becomes mandatory for device registration verification. Cross-reference the supplier's Single Registration Number (SRN), device UDI data, and certificate status across these official EU databases.

EUDAMED: The New Central Verification Platform

The European Commission, by its decision dated 26 November 2025, confirmed the functionality of four modules within the European database on medical devices (EUDAMED). EUDAMED collects and shares information on medical devices and in vitro diagnostic medical devices.

The Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices declaring the functionality of the first four modules has been published in the OJEU of 27 November 2025. In accordance with the transitional provisions set out in Regulation (EU) 2024/1860, this publication triggers a transition period of 6 months; Therefore, as from 28 May 2026 the first four modules are mandatory to use.

EUDAMED Module Functions for Verification

Step-by-Step Database Verification Process

From May 28, 2026, all new medical devices must be registered in EUDAMED. Existing devices must meet the final compliance deadline by November 27, 2026.

Before May 2026:

1. Access NANDO database at the European Commission website
2. Search by Notified Body ID number from the supplier's certificate
3. Verify the body is designated for MDR 2017/745
4. Check the scope covers the relevant device classification
5. Contact the Notified Body directly to verify certificate authenticity

After May 2026:

1. Access EUDAMED public website
2. Search the Actor module for manufacturer SRN
3. Verify device registration in UDI/Device module
4. Check certificate status in NB/Certificates module
5. Review market surveillance data for any alerts

What Information EUDAMED Provides

EUDAMED is designed to contain information such as: registration of economic operators (specifically: manufacturers, system/procedure pack producers, authorized representatives, and importers). Most of the data will be publicly available, and it is obligatory that all responsible parties populate the database with the appropriate information.

Data on economic operators, devices registration and certificates are available to the public.

Red Flags in Database Searches

When using verification databases, watch for these warning signs:

Practical Verification Timeline

The distinction between devices and SPP already on the market and new launches warrants close attention. If devices were placed on the market before 28 May 2026 and will continue to be sold thereafter, economic operators have until 28 November 2026 to register them – a welcome twelve-month window.

For importers verifying Chinese suppliers in 2026:

• Before May 28, 2026: EUDAMED voluntary; use NANDO and Notified Body direct verification
• May 28 – November 27, 2026: New devices must be in EUDAMED; legacy devices have grace period
• After November 27, 2026: All devices must be registered in EUDAMED

Conclusion

Verifying Chinese supplier CE certification for pressotherapy machines requires systematic use of official EU databases, thorough document review, and direct Notified Body confirmation. With EUDAMED becoming mandatory in May 2026, importers gain powerful new verification tools. Take time to verify every certificate. Your compliance protects your business and your customers.

Footnotes

1. Describes the purpose, legal basis, and minimum content requirements for an EU Declaration of Conformity. ↩︎

2. Official EU page explaining CE marking and its legal requirements. ↩︎

3. Official European Commission portal for the NANDO database, listing Notified and Designated Bodies. ↩︎

4. Official, consolidated text of the Medical Device Regulation (MDR) on EUR-Lex. ↩︎

5. Replaced with a direct link to the European Commission’s NANDO database, an authoritative source for Notified Bodies. ↩︎

6. Official text of the repealed Council Directive 93/42/EEC concerning medical devices (MDD). ↩︎

7. Replaced with the official EUDAMED page from the European Commission, providing authoritative information on registration. ↩︎

8. Details the required components of technical documentation under Annex II of the EU MDR. ↩︎

9. Replaced with a link to a standards body providing information on EN ISO 14971:2019/A11:2021, the standard for risk management for medical devices. ↩︎

10. Explains the mandatory role and responsibilities of an EU Authorized Representative for non-EU manufacturers. ↩︎