The first issue of MOODY NEWS collects regulatory changes, upcoming deadlines and early international signals of practical importance for the accreditation, certification, verification, conformity assessment and TIC sector.
New development
AI Act: implementation begins, high-risk deadlines are pushed back
EU · Artificial Intelligence · Regulatory Enforcement
The main set of rules from the European AI Act, as well as the powers of the European Commission regarding general-purpose models, will start to apply from 2 August 2026. The transparency regime for certain AI systems will also enter into operation, with transitional rules for some of the systems already launched. The important clarification is that the rules for high-risk AI will not come into force at the same time: the deadline for stand-alone systems is 2 December 2027, and for AI embedded in regulated products – 2 August 2028. Organisations should clarify their roles, evidence, marking of AI content and control of suppliers now.
Upcoming deadlines
CBAM examiners enter the registration phase
EU · Carbon emissions and imports · Accreditation and verification
Only verifiers accredited by a national accreditation body in the EU will be able to verify CBAM input emissions when the importer uses actual values. The practical registration phase in the CBAM Registry starts on 1 September 2026, and the first accredited verifiers are expected in September. The change affects verifiers, European importers and non-EU manufacturers. Data traceability, calculation methods, evidence from production sites and verification readiness need to be prepared well in advance. The first annual CBAM declaration for imports in 2026 must be submitted by 30 September 2027.
New rules on cobalt in toys from August 29
Bulgaria · Toys and product safety · Regulatory deadline
The next part of the amendment to the Bulgarian regulation on the essential requirements and conformity assessment of toys enters into force on 29 August 2026. It introduces specific permitted uses of cobalt in stainless steel components, electrically conductive parts and certain magnets. Manufacturers, importers, laboratories and conformity assessment bodies must check the applicability to their product portfolio. Declarations of material composition, technical files, evidence from suppliers, risk assessments and test plans should be updated as necessary.
October 1 is a key deadline for control authorities
Bulgaria · Accreditation · Transition to ISO/IEC 17020:2026
The Bulgarian Accreditation Service sets October 1, 2026 as the first key deadline for the transition to BDS EN ISO/IEC 17020:2026. By this date, accredited control bodies must submit a gap analysis and a transition plan. Failure to submit them will be considered a significant non-conformity. After October 1, documents for initial accreditation, re-accreditation and extension of scope will be accepted only under the 2026 edition. Control bodies should appoint responsible persons, review the impartiality system, competence, methods and records and coordinate the transition with the planned assessments by the BSA.
ENISA consults on a European scheme for managed security services
EU · Cybersecurity · Official consultation
ENISA is consulting on a candidate scheme for a European certification of managed security services. The initiative aims at a common framework of trust for cybersecurity providers and could influence the competence criteria, evidence, assessment and supervision of services. The consultation is open until 13 September 2026 and does not yet constitute a binding scheme. Providers, customers, certification bodies and professional organisations should review the draft early and assess whether the envisaged levels of assurance and evidence requirements are consistent with real-world service delivery models. Now is the time for reasoned opinions before the framework is finalised.
ISO 9001:2026 is just before official publication
International · Quality Management Systems · Expected Standard
The next edition of ISO 9001 is in the official „under publication“ stage, with publication expected in September 2026. This is an early strategic signal for organizations, auditors, consultants and certification bodies, but it is not yet a reason to treat the draft text as a working standard. Preparations can start with the identification of a responsible team, a review of available documentation, training capacity and planning of communication with customers. The specific transitional terms and conditions should be determined after the official publication and the decisions of the competent international accreditation infrastructure. Premature reworking of systems based on non-final texts should be avoided.
Strategic Watch
FDA now inspects manufacturers under new QMSR framework
USA · Medical Devices · Current International Baseline
As of February 2, 2026, the US FDA is implementing the Quality Management System Regulation, which incorporates by reference ISO 13485:2016 and some of the terminology of ISO 9000. For medical device manufacturers operating in the US market, the change means a new inspection approach and broader access for inspectors to records of management reviews, internal audits, and supplier audits. ISO 13485 certification does not replace compliance with FDA requirements. Bulgarian and European manufacturers should have a documented comparative analysis, verify specific US requirements, and ensure the readiness of management, suppliers, and records for regulatory inspection.
CE and UKCA continue to coexist in the British market
United Kingdom Product Conformity Market Access
The UK continues to recognise CE marking for many product regimes alongside the UKCA where the European requirements meet the objectives of the UK regulation. The UKCA allows the marking and certain information about the importer to be placed on a label or accompanying document until the end of 2027. This does not mean a one-size-fits-all regime: medical devices, Northern Ireland and individual sectoral regulations have specific routes and conformity assessment bodies. Exporters must determine the exact market, the applicable act, the permissible marking and the need for a UK Approved Body or European Notified Body before releasing the product.
WTO refocuses on recognition of conformity assessment results
International · Technical barriers to trade · Strategic signal
The WTO Committee on Technical Barriers to Trade has addressed a broad range of new and ongoing trade concerns, including cybersecurity, digital product passports, vehicles, telecommunications, food, pharmaceuticals and medical devices. Recurring issues include sufficient time for implementation, the use of international standards and the recognition of equivalent foreign regulations and conformity assessment results. This is not a new mandatory rule, but an early indicator of possible market access difficulties. Bulgarian exporters and TIC organizations should monitor specific national notifications and assess their impact before the measures enter into force.
Published by MG Global in partnership with ERPI.
English 
Български