Medical Devices:
MDCG Publishes Position Paper on UDI-DI Timelines for Optical Devices
Implementation Deadlines Set for Contact Lenses and Spectacles
On 10 July 2025, the Medical Device Coordination Group (MDCG) published its Position Paper 2025‑7, outlining the official implementation timelines for the Master UDI-DI requirements applicable to optical devices, specifically contact lenses and spectacles.
This clarification follows the regulatory obligations under the Medical Devices Regulation (EU) 2017/745 (MDR), which introduced the Unique Device Identification (UDI) system to improve traceability and transparency throughout the medical device supply chain.
Key Implementation Dates
The position paper sets the following Master UDI-DI registration deadlines:
- 26 May 2026: For contact lenses (MDR Annex XVI, group 1).
- 26 May 2028: For spectacles and spectacle frames (MDR Annex XVI, group 2).
These deadlines represent the final dates by which manufacturers must ensure that Master UDI-DI data for these device groups is registered in the EUDAMED database.
Purpose and Impact
The UDI system is intended to:
- Strengthen post-market surveillance.
- Improve market oversight by authorities.
- Facilitate product traceability and recall processes.
The implementation of Master UDI-DI ensures consistent identification of device models and configurations placed on the EU market, benefiting both regulators and end-users.
Further Information
The full MDCG 2025‑7 Position Paper is available on the European Commission’s website, offering additional guidance for manufacturers and economic operators impacted by these obligations.
EU Updates Rules on Expert Panels for Medical Devices
New Decision Enhances Oversight and Specialisation
On 7 July 2025, the European Commission adopted Decision (EU) 2025/1324, amending Implementing Decision (EU) 2019/1396 to improve the operation and scope of expert panels in the field of medical devices and in vitro diagnostic medical devices (IVDs).
The new rules enter into force on 28 July 2025.
Key Changes Introduced
- New Expert Panel on Paediatric and Rare Diseases
A dedicated panel is established to address the specific needs of children and patients with rare diseases, recognising the unique challenges and regulatory requirements of these medical areas. - Flexible Use of Expertise Across Panels
To improve efficiency and resource use, the decision allows for:
- Temporary cross-panel assignments of advisors,
- Formation of permanent or ad hoc sub-groups,
- More flexible coordination between rapporteurs and reviewers.
- Governance and Transparency Improvements
The decision mandates:
- Publication of Rules of Procedure for all expert panels,
- Standardised timelines for the panel activities,
- Harmonised criteria for expert remuneration.
Objectives and Benefits
The revised framework is designed to:
- Strengthen scientific and clinical input in the regulatory process,
- Ensure timely, high-quality opinions on high-risk medical devices and IVDs,
- Support market access for innovative and critical products—particularly those for vulnerable populations.
This update reflects the Commission’s ongoing effort to support a robust, transparent and responsive regulatory system under the Medical Devices Regulation (EU) 2017/745 and IVD Regulation (EU) 2017/746.
Further Information
The full legal text of Decision (EU) 2025/1324 is available in the Official Journal of the EU:
eur-lex.europa.eu/eli/dec_impl/2025/1324/oj/eng
Cosmetics:
EU Commission Unveils Omnibus Proposal to Simplify Chemical Regulations
Streamlining Procedures for Better Legal Clarity
On 8 July 2025, the European Commission introduced a broad Omnibus Proposal aimed at simplifying regulatory requirements and procedures for chemical products placed on the EU market.
This legislative package proposes targeted amendments to several key regulations, with the goal of reducing administrative burdens, improving legal clarity, and facilitating compliance for companies.
Key Focus: Cosmetic Products Regulation
Among the major pieces of legislation under revision is Regulation (EC) No 1223/2009 on cosmetic products. The Commission plans to:
- Clarify certain legal provisions that have led to misinterpretation or inconsistent implementation,
- Harmonise procedures across related regulations,
- Improve efficiency and transparency in the overall regulatory process.
While the specific changes to the Cosmetic Products Regulation are not yet detailed, this initiative aligns with the broader Chemicals Strategy for Sustainability (CSS) and the goal of better regulation under the EU Green Deal.
Broader Scope of the Proposal
The Omnibus Proposal also affects other areas of chemicals legislation and is part of an ongoing effort to:
- Ensure coherence across sectoral rules,
- Simplify notification, labelling, and data submission obligations,
- Improve coordination among competent authorities, agencies (e.g. ECHA), and stakeholders.
Next Steps
The proposal is currently under consideration by EU Member States and stakeholders. Once finalised, it is expected to:
- Support innovation and competitiveness,
- Ensure continued protection of health and the environment, and
- Contribute to a more predictable regulatory landscape for the chemicals sector.
Further Information
Full text and official resources:
European Commission – Simplification of certain requirements and procedures for chemical products
Biocides:
ECHA to Raise BPR Fees by 19.5% from 14 August
First Fee Increase Since 2013
As of 14 August 2025, the European Chemicals Agency (ECHA) will increase its Biocidal Products Regulation (BPR) fees by 19.5%, following the adoption of a new Implementing Regulation published on 25 July.
According to the European Commission, the increase reflects average inflation over the past four years and marks the first adjustment since the BPR entered into force in 2013.
New Fee Examples
- €143,400 – Approval of an active substance (first product-type)
- €17,925 – Renewal of approval (first product-type)
- €95,600 – Union authorisation for a single biocidal product
- €179,250 – Union authorisation for a product family
SME Discounts Maintained
Despite earlier proposals to revise them, fee reductions for SMEs remain unchanged, with discounts of up to 60% still applicable based on company size.
Industry Reaction
Several industry stakeholders have criticised the decision, calling the hike unjustified and particularly burdensome for SMEs.
REACH:
Restrictions on PFAS Use in Firefighting Foams: Legislative Overview
At a Glance
A recent circular outlines the current legislative framework on restrictions and bans related to certain per- and polyfluoroalkyl substances (PFAS) in firefighting foams, providing clarity on applicable deadlines and regulatory obligations.
Regulatory Context
Globally, several countries have adopted measures to ban or limit the manufacture, placing on the market, and use of PFAS, including those found in firefighting foams.
In the European Union, such restrictions are mainly implemented through:
- The REACH Regulation;
- Regulation (EU) 2019/1021 on Persistent Organic Pollutants (POPs), which enforces the Stockholm Convention.
These regulatory instruments establish a complex legislative landscape with different timelines and restrictions for various PFAS used in firefighting foams.
Outlook
With new limitations approaching for specific types of PFAS, it is essential for companies to prepare in advance, consider fluorine-free alternatives, and review their current stock and usage to ensure compliance with the evolving EU chemical safety framework.
Industry Raises Concerns Over Microplastics Restriction Reporting Deadlines
Context
Industry representatives are voicing concerns about the reporting timelines set out under the REACH microplastics restriction, in force since October 2023. The regulation requires annual reporting from 2027 on derogated uses and estimated emissions of microplastics.
Industry Feedback
At the 3–4 July CARACAL meeting, trade associations Cefic and DUCC highlighted practical challenges for downstream users, who rely heavily on suppliers for the necessary data to assess compliance, update safety data sheets (SDSs) and product labelling.
They stressed that the same deadline applies to both suppliers and users, even though downstream users depend on suppliers to act first. This sequential dependency, combined with the time needed for documentation updates, risks leaving downstream actors unable to meet their obligations.
Request for Flexibility
In light of these issues, the trade bodies proposed that longer timelines be granted to downstream users to ensure realistic compliance. While no concrete solutions emerged during CARACAL discussions, Cefic affirmed its commitment to continued dialogue with the Commission and stakeholders.
CLP:
European Commission Adds 22 Substances to CLP Annex VI
Key Update
On 20 June 2025, the European Commission adopted the 23rd Adaptation to Technical Progress (ATP) of the CLP Regulation, introducing new or revised harmonised classifications for 41 substances.
Highlights of the Amendment
- 22 substances have been newly classified, and 19 substances have received updated classifications.
- The most debated change involves the reclassification of nitrous oxide (dinitrogen oxide) as a category 1B reproductive toxicant.
- Other newly classified substances include ozone, barium chromate, triphenyl phosphate, and the biocidal active substance dinotefuran.
Industry Pushback
Food producers and nitrous oxide manufacturers have strongly opposed the classification of nitrous oxide, warning it could lead to a de facto ban of the substance in consumer products.
Despite objections, the Commission upheld ECHA’s scientific findings, stating that no new evidence justified deviating from the proposed classification.
Application Timeline
- The regulation entered into force on 10 July 2025.
- It will apply from 1 February 2027, giving suppliers time to update labelling and packaging and manage existing stocks under previous rules.
