Self-Care Medical Devices
Medical devices cover a wide range of products from stethoscopes to hemodialysis machines and neurostimulators that are used by health-care professionals. A specific category of medical devices comprehends those that are used in the self-care context without the involvement of a healthcare professional – self-care medical devices.
Self-care medical devices include a wide variety of products ranging from nasal sprays to intimate lubricants and products used for the reduction of bloating, as well as creams or gels to treat or prevent minor skin irritations, such as moisturizing creams or cooling gels. Self-care medical devices that are composed of substances or combination of substances are also referred to as substance-based medical devices.
Taking into account their intended use for a medical purpose, these are classified as medical devices in light of their mode of action which is not pharmacological, immunological or metabolic but relies on chemico-physical processes such as pH changes, sequestering actions of molecules, and physical barrier formation.
Self-care medical devices are currently regulated by Council Directive 93/42/EEC concerning medical devices. However, this Directive will be replaced by Regulation (EU) 2017/745 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.
The adoption of this new Regulation on 5 April 2017 establishes a new legislative framework for medical devices, including self-care medical devices. The Regulation entered into force on 25 May 2017 and will become fully applicable on 26 May 2020.
In light of the coronavirus crisis urgency, the Commission announced that it will propose a one-year delay for the Medical Device Regulation (MDR). The move is intended to relieve pressure from national authorities, notified bodies, manufacturers and other actors, and to allow them to focus fully on urgent priorities.
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By when do self-care medical devices need to comply with Regulation 2017/745?
Regulation 2017/745 will fully apply from 26 May 2020. Hence, from that date all medical devices, including self-care medical devices, must comply with the provisions of the Regulation. However, subject to certain conditions transitional periods allow medical devices with a certificate obtained under the current legislative framework to be placed on the market at the latest until 26 May 2024.
What are the changes introduced by Regulation 2017/745 concerning self-care medical devices?
Apart from general changes that affect all types of medical devices, such as improved transparency through a comprehensive EU database on medical devices and a device traceability system based on unique device identification or strengthening of post-market surveillance requirements for manufacturers, Regulation 2017/745 expressly recognizes substance-based medical devices. In particular, classification rule 21 addresses specifically medical devices composed of substances or of combinations of substances.
What is the difference between self-care medical devices and (non-prescription) medicines?
The main difference between self-care medical devices and (non-prescription) medicines concerns the mode of action. Self-care medical devices achieve their principal intended action by chemico-physical means whereas (non-prescription) medicines act by pharmacological, immunological or metabolic means.