Expression of Interest for the Designation of Technical Services
Issued by the Type-Approval Committee
Purpose and Scope
The Type Approval Committee (TAC) invites expressions of interest (EOIs) from organisations seeking designation as Technical Services in accordance with Regulation (EU) 2018/858, applicable UN Regulations, and the relevant Maltese implementing legislation.
Organisations engaged in, or intending to undertake, testing, inspection, or conformity-of-production (CoP) assessment activities that support the type-approval and related oversight functions of the Malta Type Approval Committee are encouraged to apply, provided they can demonstrate the required competence, impartiality, and compliance as specified in this call.
Designated Technical Services will operate under the oversight of the TAC, which serves as the Malta Type Approval Committee, and must perform their activities in full conformity with the applicable Union and national regulatory frameworks, as well as with the specific scope and conditions set out in their designation decision.
Definitions of key terms used in this document are available in the .
Two-Phase Selection Procedure
The process consists of two phases.
For Phase 1, you are required to submit an application form together with all mandatory supporting documentation and declarations specified therein.
Upon receipt of your submission, you will receive an acknowledgement of receipt confirming that your EOI has been registered.
The TAC will then perform an administrative review to ensure that the application is complete, properly formatted, and accompanied by all required evidence.
If the current number of designated Technical Services already meets the regulatory or operational threshold, your application will be placed in a queue pending capacity.
Applications placed in the queue remain valid and will be processed in order of receipt once capacity becomes available. You will be notified when the assessment of your application is scheduled to commence.
When capacity allows, a technical evaluation of your application will be initiated in accordance with the two-phase procedure outlined below. The TAC may contact you for clarifications or additional information as necessary.
A further assessment may be undertaken to evaluate the applicant's technical and organisational capability, verify the accuracy of the information provided, and confirm compliance with the requirements of the designation process.
Following completion of all assessment steps, you will be notified in writing of the final decision regarding your designation.
Any positive decision will specify the approved categories, scope, sites, and applicable conditions of designation.
Phase 1 – Minimum Eligibility Screening (Pre-qualification)
All applicants must demonstrate compliance with the minimum eligibility criteria set out below.
EOIs that fail to meet these criteria will not proceed to Phase 2.
1. ACCREDITATION REQUIREMENTS
Applicants must possess valid and scope-appropriate accreditations issued in accordance with Regulation (EC) No 765/2008 by a recognised national accreditation body for:
- EN ISO/IEC 17025 (latest revision) – General requirements for the competence of testing and calibration laboratories; and
- EN ISO/IEC 17020 (latest revision) – Conformity assessment – Requirements for the operation of various types of bodies performing inspection.
The accreditation scopes must, at a minimum, cover the following:
a) For EN ISO/IEC 17025 accreditation:
- Tests on lighting and light-signalling devices; and
- Emission testing.
b) For EN ISO/IEC 17020 accreditation:
- Inspections on emission requirements, and
- Coverage of the following inspection activities for vehicle categories M, N, O, and L:
- inspection of tests;
- vehicle inspection;
- inspection of components; and
- examination of documentation.
Only applicants holding current accreditation certificates that explicitly include these scopes, or equivalent, will be considered for Phase 2.
2. DESIGNATION CATEGORIES TO BE APPLIED FOR
Applicants meeting the above accreditation requirements shall apply for both of the following designation categories, as defined in Regulation (EU) 2018/858:
- Category A: tests referred to in this Regulation and in the regulatory acts listed in Annex II that technical services carry out in their own facilities; and
- Category D: the supervision or performance of tests or inspections for the surveillance of the conformity of production.
Designation will only be granted for the tasks and sites covered by the valid accreditation scopes described above.
3. GROUP APPLICATIONS
Where the EOI is submitted by a group of entities, the lead applicant must provide a Group Structure Chart and documentary evidence demonstrating that the lead applicant has legal responsibility for the designated activities, including oversight of shared resources and compliance across all group members, as defined in the of the application form.
4. MINIMUM ELIGIBILITY REQUIREMENTS
All applicants must meet the minimum eligibility requirements set out below.
EOIs that fail to meet these requirements will not proceed to Phase 2.
| Requirement | Key Aspects / Evidence Expected |
|---|---|
| Legal Status & EU Presence | The applicant must be a legal entity established in an EU Member State, with its registered office located within the European Union. |
| Group Applications & Site Specificity | For group submissions, a Lead Entity must be formally appointed to act as the single point of contact and assume full responsibility for the compliance of all group members. A Group Structure Chart must illustrate legal and operational relationships, ownership links, and resource sharing. Each member site must hold valid accreditation for the activities it performs. Applicants shall clearly identify which of their sites are considered critical, meaning locations where essential testing, inspection, virtual-testing, or CoP activities are undertaken. |
| Accreditation & Standards | Valid and scope-appropriate accreditations issued under Regulation (EC) No 765/2008 by a recognised national accreditation body for:
The 17025 accredited scope must, at minimum, cover lighting and light-signalling devices and emission tests; the 17020 accredited scope must, at minimum, cover inspections on emission requirements and inspection of tests, vehicles, components, and documentation for vehicle categories M, N, O, and L. |
| Competence & Facilities | Submission of a list of key equipment and curricula vitae of key personnel demonstrating relevant training and qualifications/authorisations. Full calibration, maintenance, and facility documentation will be verified during Phase 2. |
| Impartiality, Independence & Integrity | Organisational and operational independence from manufacturers and clients; mechanisms to identify and prevent conflicts of interest. |
| Liability Insurance | Evidence of valid insurance coverage for all designated activities, including risks associated with approvals issued by the TAC based on tests, inspections, or information provided by the Technical Service. Coverage must clearly indemnify the MCCAA, the TAC, its assessors and any person involved and/or engaged in approval-related activities for the Technical Service's actions or omissions. |
| Procedures & Systems | Overview of documented processes for legislative-update monitoring, personnel training and qualification/authorisation, control of subcontracted activities, and off-site inspector-tracking. (Tracking systems that are planned must be operational by the start of Phase 2.) |
| Declarations of Honour & Financial Stability | Submission of a signed Declaration of Honour confirming the absence of exclusion situations (professional misconduct, insolvency, criminal offences, or lack of independence) together with audited financial statements for the last completed financial year and auditor contact details. |
| Commitment to Regulatory Framework | Formal acceptance of the TAC's rules of procedure, Regulation (EU) 2018/858, applicable UN Regulations, and any national implementing measures; agreement to cooperate fully in surveillance and oversight activities. |
| Supporting Documentation | Applicants must ensure that all supporting documentation listed in the application form and accompanying checklist is duly prepared, current, and consistent with the information provided in the application. |
| Payment & Submission | Payment of any applicable administrative fee as indicated in the form. |
Phase 2 – Quality Assessment and Commitment Evaluation
Applicants shortlisted from Phase 1 will undergo a comprehensive assessment of their technical competence, organisational systems, and overall suitability for designation.
This stage verifies that each applicant possesses the capability, resources, and governance necessary to perform designated activities in a consistent, impartial, and reliable manner.
1. SCOPE OF THE ASSESSMENT
During Phase 2, the TAC will assess whether the applicant's accredited scope, internal systems, and operational arrangements are effectively implemented to support high-quality type-approval activities within the Maltese framework.
The assessment may include on-site audit, document reviews, and structured interviews with key personnel.
The evaluation will consider, inter alia:
- Technical competence and resources – the qualifications, authorisations, and experience of key personnel; adequacy of facilities, equipment, calibration, and maintenance arrangements.
- Quality-management and procedural maturity – effectiveness of documented procedures, internal-audit and corrective-action systems, impartiality and integrity controls, document management, and continual improvement.
- Operational controls – arrangements for subcontracting and witnessed testing, off-site inspections, supervision, sample custody, and verification of inspector presence through reliable tracking mechanisms.
- CoP capability – where applicable, procedures for assessing and monitoring manufacturers' CoP systems, including sampling, non-conformity handling, and escalation.
- Information-security and continuity planning – data-protection, access-control, incident-response, and business-continuity measures.
- Governance and cooperation – evidence of independence and impartiality, readiness to engage with the TAC, and adherence to financial-governance and reporting obligations.
- Accreditation maintenance and change management – systems to monitor accreditation validity, implement non-conformities from assessments, and promptly notify the TAC of material changes in scope, personnel, or facilities.
Where Phase 2 assessment elements overlap with requirements already verified through accreditation, the TAC's focus will be on how these systems and controls are implemented in relation to Malta-bound approvals. The evaluation will therefore emphasise operational readiness, cooperation mechanisms, and quality-assurance practices specific to activities performed under the authority of the Type Approval Committee.
In addition to the areas above, the TAC may evaluate any other factor considered relevant to ensuring that designated Technical Services can deliver competent, impartial, and traceable results.
2. EVALUATION CRITERIA
| Criterion | Key Aspects / Indicators | Relative Weight |
|---|---|---|
| Technical competence & facilities | Adequacy of facilities, calibration and maintenance systems, and qualified personnel; demonstrated expertise across the relevant regulatory scopes. | 35 % |
| Quality-system maturity | Effectiveness of quality-management and procedural controls, including impartiality, document control, and continual-improvement mechanisms. | 25 % |
| Oversight readiness | Proven ability to cooperate during TAC audits and witness assessments; robustness of inspection-tracking and record-keeping systems; readiness for on-site verification. | 20 % |
| Commitment to TAC objectives | Demonstrated intention and capacity to route only high-quality Malta-bound approvals to the TAC, maintain transparent and objective allocation policies, and ensure timely and effective responsiveness in all communications and submissions. | 20 % |
3. ADDITIONAL CONSIDERATIONS
The TAC may also take into account:
- evidence of sustainable Malta-bound project volume; and
- comparative accreditation strength, where two applicants are otherwise comparable, preference may be given to the entity demonstrating the broader or more robust accreditation scope within the relevant regulatory domain.
Surveillance, Audits and Sampling Requirements
The Technical Service shall be subject to at least one scheduled audit per year, which may coincide with a witnessed accreditation audit. The TAC may also conduct additional risk-based or unannounced audits at its discretion.
To verify ongoing competence and consistency, the TAC may:
- Request repeat tests, with costs borne by the Technical Service unless the tests confirm full conformity; and
- Interview inspectors or personnel to assess competence, independence, and procedural awareness.
All audit, witnessing, travel, sampling, and related costs shall be borne by the Technical Service.
Identification of Critical Sites and Additional Audits
TAC may audit critical sites in addition to scheduled and unannounced audits, on a risk basis and at the Technical Service's expense. TAC may verify location-tracking records of inspectors for assignment traceability.
Ongoing Compliance and Penalties
Technical Services must maintain compliance with this EOI, Regulation (EU) 2018/858, and applicable UN Regulations. Failure may result in suspension or withdrawal of designation and, where applicable, penalties. Each Technical Service shall maintain procedures ensuring application of the latest legislative and technical versions.
Confidentiality
All information obtained or created during assessment, designation, surveillance or reassessment shall be treated as confidential by the TAC, its assessors and any persons involved and/or engaged in approval-related activities. Technical Services shall maintain confidentiality of product data, test results and client information, disclosing only where required by law, competent authorities, or for safety notifications.
Right of Appeal
Any applicant may contest an assessment finding or designation decision through the following administrative review mechanism, as follows:
- Route: [email protected]
- Window: 10 working days from notification
- Scope: Appeals may address assessment findings or designation decisions, but not general procedural measures such as annual capacity caps applied uniformly to all applicants.
- High-level procedure: The procedure involves an arbiter mutually selected by both parties. This arbiter will hold arbitration sessions in Malta to seek a resolution to the situation. The non-aggrieved party will be responsible for paying the arbitration fees.
Fees, Cost Recovery and Throughput Caps
| Item | EUR |
|---|---|
| Application to TAC | € 800.00 |
| Documentary (desk-based) audit, per review | € 900.00 |
| Assessment (on-site), per day | € 1,800.00 |
The typical initial assessment comprises one desk-based review and two on-site audit days.
Chargeable items: Scheduled or unannounced audits, witnessed assessments, additional audits at critical sites, TAC travel and time, and any sampling or testing required. Travel and subsistence costs are re-charged at actual cost in accordance with TAC rules.
Application and assessment fees:
- An application fee of € 800.00 shall be payable upon submission and is non-refundable, including in cases where the dossier is placed in a queue for a later assessment window due to the annual throughput cap.
- Assessment fees (covering on-site evaluation days and desk reviews) shall be invoiced only once processing commences.
- Applicants may withdraw their application prior to the start of Phase 2 processing without incurring assessment charges; however, the application fee remains non-refundable.
- All fees and charges must be settled in full prior to the issuance of any designation certificate or related approval documentation.
Failure to complete payment within the indicated timeframe may result in delayed issuance or suspension of the designation decision.
The annual throughput cap is a procedural measure applied uniformly to all applicants to ensure quality, impartial scheduling, and equal treatment.
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