LEGISLATION OF COSMETICS AND MEDICAL DEVICES

LEARNING OUTCOMES

After the end of the course students will be able to know:

• The current legal framework (regulation) of cosmetics and medical devices
• The obligations of the responsible person, of distributor or representative (importer) of cosmetics & medical devices of the EU, as well as from third countries.
• The conditions for their legal and safe movement, in terms of labeling, ingredients, claims, clinical trials and safety of the final product, to the consumer.
• The basic legislative principles for the good manufacturing praxis in the industrial units (cosmetics & pharmaceutical factories)
• The requirements (conditions, possible penalties) of the authorities and the rules for ensuring the quality of the produced cosmetic products and medical devices.
• The proper observance of the necessary legal procedures and the documentation of the good manufacturing praxis(GMP)  or distribution (GDP), during the market surveillance and the 
• It will be able to understand and handle the current regulatory-legislative obligations-“Regulatory Affairs” cases in the cosmetics and medical device industry

SYLLABUS

• Definition and interpretation of the cosmetic and medical device and the current legal framework. Separation of cosmetics and medical devices from other categories (medicines, food supplements, biocides, etc.).
• The Responsibility of the Responsible person for the compliance with the provisions of the regulation. Defining the obligations of the Responsible person and the distributor. Market Surveillance by EU Member States, prior to placing on the market.
• Requirements for the Notification of the product to the National Authorities (EOF, EKAPTY). Familiarity with the environment of the European Notification “Cosmetic Products Notification Portal”
• Labeling of cosmetics and medical devices. Correct indication of claims and their limits from claims that are unacceptable and   misleading   to the consumer.
• Risk assessment and safety assessment of cosmetic products. Calculations  “Margin of Safety” of the components, according to the “NOAEL” index (Non Observed Adverse Effect Level) and assessment of the possible risks of raw materials, packaging materials and final products based on their physico-chemical and microbiological analysis -recommendation. Existence of contaminants, “impurities”, dioxins, phthalates, genetically modified ingredients, heavy metals, etc.)
• Creation of a Product information file for cosmetics, according to EOF & the EU.
• Cosmeto-Vigilance . Necessary steps for handling, recording, evaluating and informing the competent  authorities.
• Rules for classification of medical devices. Specific definitions of classification rules. Date of minimum durability. Distinction of CE I, CE IIa, CE IIb, CE III compliant products. Rules of application. Non-invasive and invasive technology products.
• Preclinical & Clinical Evaluation of the safety of medical devices. Collection and analysis of the necessary bibliographic data, laboratory or “in vivo” tests for the final assessment of safety to the consumer.
• Management and risk assessment  in medical devices, in accordance with ISO 14971: 2007
• Creation and Approval of the product information file and the quality assurance system, according to ISO 13485: 2012, by the competent authorities (National Center for Quality Assessment and Health Technology).
• Management of Non-Compliant Products. Recalls (handling, traceability system, cooperation with authorities). Market Surveillance. Corrective actions and sanctions by the competent authorities.
• “SOP” (Standard Operating Procedures), which must be observed, evaluated, upgraded and governed by a legally integrated quality assurance system and assessment of a potential market risk.