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Glossary · Areas

# Regulatory watch for quality and regulatory affairs: from public consultation to application date

**In short** 

Regulatory watch for quality and regulatory affairs is the systematic monitoring of official gazettes, standards in preparation, harmonised standards and public consultations, to find out which requirement is changing, which product or process it affects and from when it is enforceable. It lets teams update technical files, tests and procedures before the application date, and keep evidence of when and how each change was known.

## What decisions does a quality team take when a standard changes?

-   **Review the technical file and the EU declaration of conformity** for each affected product.
-   **Repeat or extend tests** when the harmonised standard on which conformity was based is replaced.
-   **Update internal procedures, instructions and labelling.**
-   **Plan the audit** of the management system or product certification against the new requirement.
-   **Decide whether to take part in a public consultation** while the text can still change.

Access is not the problem: official gazettes are public, and the BOE publishes its tables of contents as open data[\[1\]](https://www.innguma.com/en/solutions/quality-regulatory/#ref-1). The problem is separating, from everything that is published, what affects a given product range or a specific process.

## Where is each type of regulatory change published?

-   **Official Journal of the EU (EUR-Lex), the BOE and regional gazettes.** Regulations, directives, delegated and implementing acts, and the laws and royal decrees that transpose them.
-   **References to harmonised standards in the Official Journal of the EU.** Using harmonised standards is voluntary, but the publication of their reference is a precondition for them to confer a presumption of conformity[\[2\]](https://www.innguma.com/en/solutions/quality-regulatory/#ref-2). A reference that is withdrawn or replaced, with its date, obliges you to review the basis of conformity.
-   **UNE draft standards open to public information.** Each month the Ministry of Industry publishes in the BOE a resolution listing the draft standards open to public information. The one of 1 October 2026, which covers those of September, sets comment periods of 20, 30 or 40 calendar days depending on the draft[\[3\]](https://www.innguma.com/en/solutions/quality-regulatory/#ref-3).
-   **Public consultations in Spain.** Ministries publish on their websites the prior public consultation and the hearing and public information stages of their regulatory drafts[\[4\]](https://www.innguma.com/en/solutions/quality-regulatory/#ref-4).
-   **European Commission consultations.** The ‘Have Your Say’ portal lists consultations and comment periods on initiatives and delegated acts[\[5\]](https://www.innguma.com/en/solutions/quality-regulatory/#ref-5).
-   **Penalty decisions and product recalls.** They show what the authority interprets as non-compliance.

## What to monitor within CE marking and the New Legislative Framework

CE marking rests on the New Legislative Framework: the essential requirements are set out in product legislation, and the way to meet them in harmonised standards and conformity assessment procedures. The Commission explains this system in the Blue Guide on the implementation of product rules, whose 2022 edition is a non-binding document covering conformity assessment, accreditation, CE marking and market surveillance, and including distance selling and software updates[\[6\]](https://www.innguma.com/en/solutions/quality-regulatory/#ref-6).

For consumer products with no specific harmonised legislation, Regulation (EU) 2023/988 on general product safety has applied since 13 December 2024 and replaced Directive 2001/95/EC[\[7\]](https://www.innguma.com/en/solutions/quality-regulatory/#ref-7). In practice, a quality team needs three separate watches: the legislation for each product family, the harmonised standards that implement it, and the public information on draft standards.

## Publication is not application: the three stages of a standard

1.  **While it is being drafted.** A public consultation or draft standard. This is the time to estimate the impact and, where appropriate, submit comments.
2.  **When it is published.** The text is final: who it affects, what it requires and from when.
3.  **When it starts to apply.** Many standards phase in their obligations, and the 2025 and 2026 omnibus packages have moved several dates already published.

| Standard | Obligation | Date in force in October 2026 |
| --- | --- | --- |
| Regulation (EU) 2024/1689 on artificial intelligence[\[8\]](https://www.innguma.com/en/solutions/quality-regulatory/#ref-8) | Transparency under Article 50 | 2 August 2026 |
| Regulation (EU) 2024/1689, amended by Regulation (EU) 2026/1744[\[9\]](https://www.innguma.com/en/solutions/quality-regulatory/#ref-9) | High-risk systems in Annex III | 2 December 2027 (previously 2 August 2026) |
| Regulation (EU) 2024/1689, amended by Regulation (EU) 2026/1744[\[9\]](https://www.innguma.com/en/solutions/quality-regulatory/#ref-9) | High-risk AI integrated into regulated products (Annex I) | 2 August 2028 (previously 2 August 2027) |
| Directive (EU) 2022/2464 (CSRD), amended by Directive (EU) 2026/470[\[10\]](https://www.innguma.com/en/solutions/quality-regulatory/#ref-10) | Sustainability reporting for companies with more than 1,000 employees and €450 million in turnover | Changes to be transposed by 19 March 2027 |
| Regulation (EU) 2023/988 on general product safety[\[7\]](https://www.innguma.com/en/solutions/quality-regulatory/#ref-7) | Safety requirements for consumer products | Applicable since 13 December 2024 |

That is why regulatory watching does not end when a standard is published: it is also worth tracking the acts that amend it before it applies.

## How to turn a provision into a compliance task

1.  **Identify the provision** with its official reference and a link to its source.
2.  **Define the scope**: which product families, processes or sites it affects.
3.  **Set the date that governs**: publication, entry into force or application, and whether there is a transitional period.
4.  **Assign an owner** and the action: testing, a documentation change, training or a comment on the consultation.
5.  **Keep the evidence** of when it was known, who assessed it and what was decided. In an audit, that traceability counts as much as compliance itself.

## What Innguma does for quality and regulatory affairs

Innguma continuously monitors regulation, the BOE, news, websites and specialist sources, and Innguma’s AI classifies each provision by category, technology, entity and type of event. What the team validates is kept in the Library with its source, its tags and its comments, searchable as a history; regulatory newsletters are sent from it, with summaries generated by AI. The legal and technical interpretation remains the team’s: the AI processes the information, and people decide what is published and who receives it. Innguma’s own technology watch and intelligence system is certified under UNE 166006:2018 (certificate 34/5705/25/01139, OCA Global, valid until January 2028).

Use case

## How the day-to-day changes

**Today, in many teams** 

-   Manual, partial reading of official gazettes.
-   The withdrawal of a harmonised standard is discovered during the audit.
-   Changes in dates learnt through a customer or a supplier.

**A day with Innguma** 

1.  When reviewing the watch 
    
    The provisions in the official gazettes that affect your product families, sorted by topic.
    
2.  When a consultation opens 
    
    The draft regulation or UNE draft standard, with its comment deadline as stated in the source.
    
3.  During an audit 
    
    The history of each standard in the Library: date, source and the team's comments on its scope.
    

**Dates under control** 

Each obligation with its application date, also when an omnibus package changes it.

**Traceability for audits** 

When each change was known and what was decided, with its source.

**Focused reading** 

The team reviews what affects its product, not the whole gazette.

**How Innguma does it** 

-   Continuous monitoring of regulation, Spain's Official State Gazette (BOE), the Official Journal of the EU and specialist sources, classified by Innguma's AI.
-   Tracking of public consultations and draft standards as watches in their own right.
-   History in the Library, searchable by topic, standard and date.

**What does not change** 

Whether a standard applies to a product, how conformity is demonstrated and whether to comment on a consultation is decided by the quality team. Innguma gathers and organises the provisions; the technical and legal judgement is yours.

**Where to start** 

1.  A watch on *the legislation for each product family in the Official Journal of the EU and the BOE*
2.  A watch on *harmonised standards and UNE draft standards from your committees*
3.  A watch on *Spanish and European public consultations that affect you*

[See it with my topics](https://www.innguma.com/en/demo/)

Illustrative example of a typical use.

## Sources and references

1.  \[1\] [Spain's Official State Gazette (BOE). Open data](https://www.boe.es/datosabiertos/)
2.  \[2\] [European Commission. Harmonised standards](https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards_en)
3.  \[3\] [Resolution of 1 October 2026, of the Directorate-General for Industrial Strategy and Small and Medium-sized Enterprises, submitting the UNE draft standards of September 2026 to public information. BOE No. 254. 2026](https://www.boe.es/boe/dias/2026/10/13/pdfs/BOE-A-2026-21301.pdf)
4.  \[4\] [Order PRE/1590/2016, on public participation in the regulatory drafting process. BOE. 2016](https://www.boe.es/eli/es/o/2016/10/03/pre1590)
5.  \[5\] [European Commission. ‘Have Your Say’ portal](https://have-your-say.ec.europa.eu/index_es)
6.  \[6\] [European Commission. The Blue Guide on the implementation of product rules 2022 is published. 2022](https://single-market-economy.ec.europa.eu/news/blue-guide-implementation-product-rules-2022-published-2022-06-29_en)
7.  \[7\] [Regulation (EU) 2023/988 on general product safety. EUR-Lex. 2023](https://eur-lex.europa.eu/eli/reg/2023/988/oj)
8.  \[8\] [Regulation (EU) 2024/1689 on artificial intelligence. EUR-Lex. 2024](https://eur-lex.europa.eu/eli/reg/2024/1689/oj)
9.  \[9\] [Regulation (EU) 2026/1744 amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 (digital omnibus on AI). EUR-Lex. 2026](https://eur-lex.europa.eu/eli/reg/2026/1744/oj?locale=es)
10.  \[10\] [Directive (EU) 2026/470 amending the directives on corporate sustainability reporting and due diligence. EUR-Lex. 2026](https://eur-lex.europa.eu/eli/dir/2026/470/oj)

## Related

- [Watch for product teams: competitors' launches and the requirements that reach the design](https://www.innguma.com/en/solutions/product/)
- [What is UNE 166006?](https://www.innguma.com/en/resources/faq/une-166006/)
- [The Innguma Library: your organisation's watch memory](https://www.innguma.com/en/resources/software/library/)
- [Can I always see the original source of a signal?](https://www.innguma.com/en/resources/faq/original-source/)

- [Request a demo for Quality and regulatory affairs](https://www.innguma.com/en/demo/)
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