What is changing in the rules, what it means for your product, your municipality or your project, and who here handles it. In English and Portuguese.
Our monitoring reports record the changes to cosmetics rules in a given period, and we publish one each month. Each one is a dated publication: it reflects the rules on the date it was published and is not updated afterwards. For what applies today, read the latest briefings or ask us.
A substantial change to an IVDR performance study must be notified within one week and cannot start for 38 days. Why the MDCG 2022-20 template still applies while EUDAMED's module is pending.
Four EUDAMED modules have been mandatory since 28 May 2026. Devices already on the market have until 27 November 2026. Who registers what, and what changed in Portugal.
From 25 February 2027, notified bodies under the MDR and IVDR must quote on defined information, keep to maximum timelines and publish their performance. What it changes for manufacturers.
Whether software is a medical device depends on what you say it is for, not on the code. The qualification test under the MDR and IVDR, updated for 2025 guidance.
Clinical data from an equivalent device can support your clinical evaluation, but the MDR sets a higher bar than the Directives did. The three characteristics, data access, and documentation.
A non-EU manufacturer needs an EU Authorised Representative; every manufacturer needs a PRRC. What each must do under the MDR, and what EUDAMED adds from 27 November 2026.
Class IIa, IIb and III devices need a periodic safety update report. How often, how to group devices, and where it goes while EUDAMED's vigilance module is pending.
Once software qualifies as a medical device, Rule 11 of MDR Annex VIII decides its class. How the rule works, and why so little software stays in class I.
Ingredient: CYCLAMEN ALDEHYDE
Date of publication: 8 June 2026
The Scientific Committee on Consumer Safety (SCCS) has accepted a mandate to assess the safety of Cyclamen Aldehyde, following potential classification as a reproductive toxicant under the CLP Regulation.
Topic: OMNIBUS ACT IX - COSMETICS REGULATION
Date of publication: 28 July 2026
The European Commission notified the WTO about the draft Omnibus Act IX, proposing amendments to Annexes II, III, and V of the EU Cosmetics Regulation.
Ingredient: CYCLAMEN ALDEHYDE
Date of publication: 8 June 2026
The Scientific Committee on Consumer Safety (SCCS) has accepted a mandate to assess the safety of Cyclamen Aldehyde, following potential classification as a reproductive toxicant under the CLP Regulation.
Topic: OMNIBUS ACT IX - COSMETICS REGULATION
Date of publication: 28 July 2026
The European Commission notified the WTO about the draft Omnibus Act IX, proposing amendments to Annexes II, III, and V of the EU Cosmetics Regulation.
Topic: NEW RESTRICTIONS ON COSMETIC INGREDIENTS
Date of publication: 13 January 2026
The European Commission published Commission Regulation (EU) 2026/78, which brings new restrictions on several cosmetic ingredients that were classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR).
Ingredient: TALC
Date of publication: January 2026
The United Kingdom (UK) Health and Safety Executive (HSE) has published a technical report concluding that Talc does not warrant carcinogenicity classification, diverging from ECHA's Risk Assessment Committee (RAC) opinion supporting Category 1B classification.
A non-EU manufacturer needs an EU Authorised Representative; every manufacturer needs a PRRC. What each must do under the MDR, and what EUDAMED adds from 27 November 2026.
Class IIa, IIb and III devices need a periodic safety update report. How often, how to group devices, and where it goes while EUDAMED's vigilance module is pending.
Once software qualifies as a medical device, Rule 11 of MDR Annex VIII decides its class. How the rule works, and why so little software stays in class I.
A substantial change to an IVDR performance study must be notified within one week and cannot start for 38 days. Why the MDCG 2022-20 template still applies while EUDAMED's module is pending.
One email when an area publishes, in the language you choose. Nothing else.
