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Medical devices Regulation Regulation

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  Directive

Medical devices Regulation ((EU) 2017/745)

  Scope

This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.


This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for analogous devices with a medical purpose, based on similar technology. The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety.


This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph.


ANNEX XVI

LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)

  • Contact lenses or other items intended to be introduced into or onto the eye.
  • Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
  • Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
  • Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
  • High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
  • Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.

EXCLUSIONS

This Regulation does not apply to:

  • In vitro diagnostic medical devices covered by Regulation (EU) 2017/746;
  • Medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether a product falls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product;
  • Advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;
  • Human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or put into service, such blood products, plasma or cells, except for devices referred to in paragraph 8 of this Article;
  • Cosmetic products covered by Regulation (EC) No 1223/2009;
  • Transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or are rendered non-viable;
  • Transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable;
  • Product, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product;
  • Food covered by Regulation (EC) No 178/2002.

DEFINITIONS

For the purposes of this Regulation, the following definitions apply:

  • ‘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 one or more of the following specific medical purposes:
    • Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
    • Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
    • Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
    • Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

  • Devices for the control or support of conception;
  • Products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

  Description

Medical Devices Regulation (EU) 2017/745 has replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD), whereas the IVDR will replace the In vitro Diagnostic Directive (IVDD). Both regulations bring a series of important improvements to conformity assessment for medical devices with the intention to: Improve the quality, safety and reliability of medical devices placed on the European market. Strengthen transparency of information related to medical devices for consumers and practitioners. Enhance vigilance and market surveillance of devices in use. The extent to which these changes will affect your operations will depend on the type of device manufactured and the role you hold (manufacturer, importer, authorized representative). It is however anticipated that in most cases significant changes must be made to compliance process, quality management system, and technical documentation and successfully implemented, and certified as relevant to device classes and roles of your organization, before compliance with the regulations can be achieved.

  Harmonised standards

EN 285:2015+A1:2021 Sterilization - Steam sterilizers - Large sterilizers
EN ISO 10993-9:2021 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
EN ISO 11135:2014/A1:2019 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd...
EN ISO 11137-1:2015/A2:2019 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd...
EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
EN ISO 11737-1:2018/A1:2021 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
Show all the standards...
EN 285:2015+A1:2021
Sterilization - Steam sterilizers - Large sterilizers
EN ISO 10993-9:2021
Biological evaluation of medical devices - Part 9: Framework for identification and quantification o...
EN ISO 10993-12:2021
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO ...
EN ISO 10993-23:2021
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
EN ISO 11135:2014
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
EN ISO 11135:2014/A1:2019
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
EN ISO 11137-1:2015
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation...
EN ISO 11137-1:2015/A2:2019
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation...
EN ISO 11737-1:2018
Sterilization of health care products - Microbiological methods - Part 1: Determination of a populat...
EN ISO 11737-1:2018/A1:2021
Sterilization of health care products - Microbiological methods - Part 1: Determination of a populat...
Show all the standards...

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