The Scope of the EU Medical Device Regulation

The Scope of the EU Medical Device Regulation

The European Union (EU) Medical Device Regulation (MDR) is due to take full effect in May 2020, and its new scope includes a large number of products and devices that were outside the scope of the EU Medical Device Directive (MDD). Some of these newly in-scope products do not even have medical applications.

Broadened Definitions for Regulated Devices

In keeping with the MDD, active implantable medical devices and devices used for medical purposes are regulated under the MDR. However, the greater number of products in scope of the new regulation stems in part from the added legal text in Section 10.4 of Annex 1, which outlines requirements and criteria for the design and manufacture of medical devices.

These added criteria include devices that come into direct contact with the body, and devices that administer medicines, body liquids, gases and other substances to or from the body, in addition to the expected invasive devices.

These criteria bring a surprising number of devices without a specific medical purpose into scope. These products include:

  • Throat lozenges.
  • Nasal sprays.
  • Sunscreen products and dispensers.
  • Gels or creams in a tub.
  • Soap dispensers.
  • Colored contact lenses.

The good news for manufacturers is that most of these products will likely be Class I devices, only requiring a self-assessment.


What’s the next step after scoping your supply chain and collecting data? Download our guide to learn more.


Products With No Intended Medical Purpose

Annex XVI also names six groups of in-scope products that have no intended medical purpose:

  • Contact lenses “or other items intended to be introduced into or onto the eye.”
  • Products that surgically modify the anatomy or fixation of parts of the human body, either partially or totally.
  • Substances and other items used as fillers, such as dermal or subcutaneous fillers, though substances used for tattoos are excluded from this.
  • Equipment to remove, reduce or destroy adipose tissue.
  • High-intensity electromagnetic radiation-emitting equipment for use on the human body (such as intense pulsed light equipment, skin resurfacing equipment, and tattoo or hair removal equipment).
  • Equipment intended for brain stimulation via modification of neuronal activity.

Scoping the Supply Chain

Companies facing challenges from the EU MDR should start collecting supply chain data to conduct an assessment of their products based on Section 10.4 of the regulation’s legal text. Once products are compared against the criteria established by Section 10.4, Annex VIII of the EU MDR legal text contains 22 rules for classifying medical devices.

Determining device classification will dictate the next steps that need to be taken to certify a product and ensure it can make it to market.

The Assent Compliance Platform helps companies streamline the collection of supply chain data to support a variety of risk mitigation activities, including compliance with the EU MDR. To learn more about Assent’s solution, email info@assentcompliance.com.

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