Borderline between medical devices and medicinal products – MDCG Guideline 2022-05 unsettles the market

The MDCG Guideline 2022-05 (Demarcation Guideline), published on 26.04.2022, aims to provide a harmonised interpretation throughout Europe of Regulation (EU) 2017/745 on medical devices (MDR) regarding the demarcation of medical devices and medicinal products.

Key issues of the Demarcation Guideline are:

  • the revision of the legally undefined concept of pharmacological, immunological and metabolic means (PIM), the decisive demarcation criterion between medical devices and medicinal products
  • the interpretation of Classification Rule 14 for medical devices with ancillary medicinal effects
  • the inclusion of a separate section on herbal medicinal products.

Contrary to extensive advice from the European medical device and pharmaceutical industries associations, the Demarcation Guideline is inconsistent, scientifically and regulatory questionable and not in line with legal interpretations of the European Court of Justice. The "enhanced coordination" procedure, established for the first time in the context of MDCG guidelines, is an attempt to resolve the ambiguity and thus underlines the uncertainty of COM and MDCG about how the Demarcation Guideline should be applied.

The Demarcation Guideline does not generate harmonisation. On the contrary, due to the ambiguities, a disagreement with Notified Bodies or Competent Authorities regarding the qualification and classification of the products is to be expected. The loss of safe and efficient medical devices for self-medication is therefore the feared consequence of the Demarcation Guideline.

The preservation of the marketability of medical devices composed of substances or combinations of substances depends directly on interpreting the Demarcation Guideline wisely, arguing confidently and making viable decisions.

We advise, inform and support you on all topics relating to substance based medical devices. Diapharm is your experienced and professional partner for the preservation of your medical devices, particularly when it comes to questions of demarcation.

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