ANNE-LAURE TARDY*
RNI Conseil
2 Rue de Bel Air- 49000 Angers, France

Abstract

Consumer healthcare products can fall into different regulatory categories. Browse from a status to another is critical for setting up the regulatory and the marketing authorization strategies. Indeed, this article aims to provide a general overview of the future new medical device and medicinal products regulations in order to provide first clues for the readers. For each status, regulatory framework, product definition and classification will be detailed. In addition, key actors and marketing procedure of the products will be provided. Finally, the safety and efficacy requirements and documentation for marketing authorization will be outlined.

Regulatory frameworks, definition & classification of the products

After several years of negotiation, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (MDR) has entered into force on 26^th may 2017 and shall apply from 26^th may 2020. Main objectives are to improve patients and users safety, to increase medical devices traceability, to enhance notified bodies role, to specify the obligations of manufacturers/ importers/ distributors and to strengthen the requirements for clinical evidences. “Medical device” means : any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for […] specific medical purposes, for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, […], investigation, replacement or […], and which does not achieve its principal intended action by ph ...