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THE INDEPENDENT VOICE OF TRUST

THE IMPACT OF COVID ON REGULATORY ACTIVITIES AND MARKET SURVEILLANCE

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TIC CouncilThe Independent Voice of Trust• Born from the merger of IFIA and CEOC

• ~90‐member companies & organizations active in more than 160 countries (HQ mapped) 

• TIC Council has its head office in Brussels. It also has an office in Washington and presence in India.

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TIC Council Vision

For the TIC Council to be recognized and trusted globally as the voice ofthe independent testing, inspection and certification industry, and tostand for best practice and the highest standards in safety, quality, health,ethics and sustainability.

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TIC Council Compliance Programme

Protect the trust, social responsibility and reliability of the sector

Principles:• Integrity• Conflict of Interest• Confidentiality and Data Protection• Anti‐Bribery• Fair Business Conduct• Health and Safety• Fair Labour

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Certification Bodies and Product Certification

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COVID‐19: how TIC supported

Testing of PPE & medical facilities

Example: EU asked for prioritizing PPE

Continuity of critical infrastructure’s functioning

Examples: food, water and energy testing continued

Individual members offered services for free or contributed to research.

Members now offer certification based on protocols for safe return toactivities

Examples: employees health, tourism, catering

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COVID‐19: challenges

Lockdown included TIC employees/companies

Cases in India

Free cross‐border movement of TIC restricted

Examples: cross‐border EU & off‐shore inspectors in quarantine

Limited flexibility for remote audits

Example: food‐related activities overly limited

Confusion and counterfeit certificates

Increase in counterfeit PPE (Europol data)

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Counterfeit Certificates: Case Study

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Validating Marks and Certificates

TIC Council recommends that authorities and purchasers of products, such as PPE and medical devices verify the validity of any claims of compliance and certificates of conformity.  

This includes:

Requesting a certificate

Validating the certificate or product certification mark by contacting the identified certification body

If you cannot identify or contact the certification body contact the TIC Council secretariat (secretariat@tic‐council.org).  

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Marks and Certificates: Red Flags

Mismatch between product and paperwork, or within the paperwork.• Products are not the same (includes description, model number, and branding) as what 

is identified on the certificate as what is indicated in shipping/import paperwork

Is the certificate type applicable for that product type?  • For example, an ISO 9001 Certificate does not support or validate the compliance of 

PPE such as masks, gloves, or gowns.

If PPE or medical devices is marked with a CE + Four Digits, that should be reviewed further.

(EU) 2020/403 Recommendation is implemented by Member States. Therefore, current requirements must beconfirmed with the national competent authority.

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Verification of EU – Type Examination Certificate PPE Respiratory Protection Masks are classified as Category III

Necessary documentation to be issued by a Notified Body for these products

Type Approval (Annex V/ Module B)

The certificate needs to be clearly identified as an EU – Type Examination Certificate(documents as “Certificate of CE conformity” or Attestation of Conformity” only indicate that the issuing party evaluated the conformity of the product however does not have any legal effect)

Evaluation of internal quality assurance system of manufacturer

a) (Annex VII /Module C2) product verification tests or

b) (Annex VIII /Module D) quality assurance of production process

The certificate needs to be issued by a Notified Body of the EU. The number of Notified Body used for step 2will be indicated

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Notified Body Code

Each Notified Body has a unique code.

In areas where a Notified Body needs to be involved (e.g. PPE) the product needs to showa CE mark with the four (4) digit code of the related Notified Body.

The Notified Body as well as its scope can be easily identified via “NANDO” database:https://ec.europa.eu/growth/tools‐databases/nando/

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Helpful Hints

MEMBER Certification Directory

MEMBER Certificate

Product Marking Plate

Certificate & DoC needs to MATCH the PRODUCT

Certificate needs to be validDeclaration of Conformity 

(DoC)

If core information is NOT 100% identical, contact relevant certification body

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Lessons for the future

In times of urgency or financial constraint, TIC is a partner to market surveillanceauthorities

TIC can reduce significantly the number of non‐compliant and dangerous products onthe market

Thereby, TIC enables MSAs to focus on intentionally rogue traders and removedangerous products

TIC actively chase counterfeit certificates

Over‐reliance on self‐declaration of conformity brings consumers in risk

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Follow us online 

Wikipedia page: Testing, inspection and certification

@TICCouncil TIC Council

TIC‐Council.org 

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