Apr 27, 2022

A European Commission working group has published new guidance on distinguishing between medical devices and medical products under the Medical Devices Regulation (MDR).

The new guidance from the European Medical Device Coordination Group (MDCG) covers “borderline products” not easily categorized either as medical devices falling under MDR requirements or medical products for human use falling under Directive 2001/83/EC (MPD) requirements for CE Marking.

Defining medical devices and medical products

How a borderline product is defined helps determine whether that product must comply with the MDR or MPD, according to the MDCG guidance.

  • Borderline products must meet the MDR definition and scope of a medical device or accessory to a medical device in order to fall under the Regulation’s requirements
  • Products must meet MPD definitions of a medical product in order to fall under 2001/83/EC requirements:
    • Any substance or combination of substances with properties for treating or preventing disease
    • Any substance used in human beings to restore, correct or modify physiological functions via pharmacological, immunological or metabolic means

The principal mode of action criterion

Because both medical devices and medical products may be intended to treat or prevent disease, the guidance identifies the “principal mode of action” as the key factor for distinguishing between a medical device and a medical product. In cases where a particular borderline product exhibits characteristics of both a medical device and a medical product, MPD provisions and requirements ultimately apply, states the guidance. “The MDR and the MPD may not be applied cumulatively.”

Article 2(1) of the MDR notes that medical devices’ principal modes of action typically entail physical means—not pharmacological, immunological or metabolic.

“According to Article 2(1) MDR a medical device does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but may be assisted in its function by such means,” states the MDCG guidance.

Manufacturers must provide justifications for rationales regarding their devices’ principle modes of action within their technical files submitted to Notified Bodies in order to support claims that they meet MDR medical device rather than MPD definitions.

The MDCG guidance includes additional references and resources to support manufacturers determine whether their borderline product qualify as medical devices or medical products.

Learn more about European medical device regulatory compliance at Emergo by UL:

 

Author

  • Stewart Eisenhart

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