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11/6/2020
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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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