CRITICAL CATALYST - Health Consulting Lda.

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Critical Catalyst provides a wide range of regulatory and technical consulting services that guarantees, in a cost-effective way, the full compliance of cosmetics and medical products with all applicable legal requirements across international markets Critical Catalyst portfolio includes manufacturers and distributors from several industries located worldwide

Our company operates internationally rendering end-to-end regulatory services for placing medical devices, particularly medical software qualified as medical device under EU legislation, and cosmetic products on the market Along with the regulatory and technical support, we review all stages of the product’s life-cycle and make a prospective analysis of its present and future regulatory needs

Understanding the ISO Standards Lifecycle

Reclassification of Active Products without Intended Medical Purpose in the European Union

Amendments to the Transitional Provisions of the European Union MDR and IVDR

EU MDR – Proposal for Extension of Transition Period

MDCG 2022-18 – EU MDR Article 97

Availability of Medical Devices in Europe After MDR Implementation – Findings From Medtech Europe Survey Report

EU to set Labelling Requirements for 56 additional Fragrance Allergens in Cosmetic Products

New Amendments to the European Cosmetics Regulation – CMR Substances

Common Specifications for Class D In Vitro Diagnostic Medical Devices

EUDAMED – harmonized practices and alternative solutions for IVDR until the database is fully functional

EUDAMED – update on timelines

UK OPSS call for data on six cosmetic ingredients

European Commission’s Notification to WTO of Amendments on Annex III and Annex VI to Cosmetics Regulation

Updated Glossary of Common Ingredient Names

European Commission Recommendation on the Definition of Nanomaterial

New Formaldehyde Threshold – Amendment to Cosmetic Products Regulation

New Restrictions on the Use of Benzophenone-3 and Octocrylene as UV Filters in Cosmetic Products

Expected Restriction on the Use of Methyl Salicylate

Aplicação do Novo Regulamento Europeu de dispositivos médicos para diagnóstico in vitro em Portugal

Date of application of new EU In Vitro Diagnostics Regulation

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