EU Omnibus IV: Digital Product Documentation & Compliance Updates

🇻🇳 Vietnam Standards & Technical Regulations Law: Digital DoC Storage + CAB Recognition

Vietnam has revised its Standards and Technical Regulations Law to enhance transparency and align with international trade agreements like CPTPP, EVFTA, and RCEP.

Key updates include clearer definitions for standards, technical regulations, and conformity assessment activities. The term "conformity assessment body" will be used in place of "conformity certification body," with stricter standards applied to these entities.

Results from foreign conformity assessment bodies may be recognized under international agreements, reducing the need for retesting. All declarations of conformity will be digitally stored in the National Standards, Measurement, and Quality Database.

Developing standards in digital transformation, high technology, and export-oriented sectors will be prioritized.

Status: Active enforcement - By modernizing Vietnam's legislation, it aims to create a more transparent, efficient, and harmonious environment for both domestic and international companies and to strengthen international trade. The new regulation will cover all electronic products, artificial intelligence products, and IoT products.

Learn more here

🏭 What This Means for Manufacturers

• Evaluate existing conformity documentation and identify gaps in digital storage readiness.
• Partner with internationally recognized assessment bodies to streamline market entry.
• Reassess compliance for AI and IoT products — new local standards may trigger redesigns or retesting.

🇪🇺 EU Omnibus IV Package (May 2025): Digital Manuals + Digital Declarations of Conformity (Consultation to 28 July)

On May 21, 2025, the European Commission published Omnibus IV, a comprehensive legislative package aimed at facilitating and streamlining measures for both small and medium-sized enterprises (SMEs) as well as larger businesses.

The primary objective of this package is to simplify the legal obligations of businesses operating within the EU internal market, thereby accelerating digital transformation and fostering sustainability initiatives.

Key areas of focus within the Omnibus IV package include digitalization, the reduction of paper-based processes, regulations about batteries, product safety, fluorinated gas (F-gas) management, and adherence to General Data Protection Regulation (GDPR) requirements.

Status: Active enforcement - This package will affect all sectors with trade relations with the EU. The EU Commission has been working on a digital transition, particularly in product documentation (such as user manuals and declarations of conformity) for a long time.

With the development of artificial intelligence systems, manufacturers, importers, and exporters will need to adapt to these systems. Public consultation will be open until 28 July.

Learn more here

🏭 What This Means for Manufacturers

• Transition compliance documentation (e.g. user manuals, DoCs) to digital formats in line with new EU expectations.
• Prepare for mandatory integration of AI systems into product safety and labeling compliance workflows.
• Engage in the public consultation before 28 July to influence outcomes and pre-empt future obligations.

🇲🇩Moldova Conformity Assessment Reform: EU Alignment (EC 765/2008, Decision 768/2008)

In June 2025, the Republic of Moldova began the process of amending its legislation regarding accreditation and conformity assessment.

These updates are part of Moldova's broader efforts to align its national regulations with European Union law as the country pursues EU membership.

The revised legal framework incorporates essential elements of Regulation (EC) No. 765/2008, which focuses on accreditation and market surveillance, as well as Decision No. 768/2008/EC concerning product marketing and Regulation (EU) No. 1025/2012 on standardization.

While the legislation has been submitted for parliamentary approval, it has not yet come into effect. Once approved, the provisions will take effect 12 months after the date of approval.

Status: Active enforcement - Please note that this change will affect all sectors wishing to sell products in Moldova. Moldova is currently in the EU harmonization process and is working to implement EU certification and standardization standards. As a result, you will need to prepare your products by these requirements.

Learn more here

🏭 What This Means for Manufacturers

• Treat Moldova as an emerging EU-aligned market — anticipate CE marking and standardization requirements.
• Adjust certification and market entry processes for Moldovan exports to reflect EU legislation timelines.
• Assign cross-functional teams to monitor Moldovan regulatory developments over the next 12 months.