MDCG 2022-5 – guidelines for medical device and medicinal products under Regulation (EU) 2017/745 on medical devices. The MDCG2022 new guidance document gives clarification about regulatory framework for borderline cases, it provides flow chart for developers to understand the definition of medical device under the MDR. This document discusses about the borderline between the medical device (MDR) and medicinal product (MPD). It also provides the relevant definitions and examples .Herbal products, substance-based devices, medical device and medicinal product combinations are discussed separately. Borderline products are those where it is not clear from the outset whether they fall under the MDR or the MPD. In general the product is regulated either by MDR or MPD but not both.
MDCG 2022-5 – guidelines for medical device and medicinal products :
As per the medical device article2(1) MDR 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, tracking, prediction, prognosis, remedy or relief of sickness
- providing information by using in vitro exam of specimens derived from the human frame, inclusive of organ, blood and tissue donations,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
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.
Whereas medicinal product is:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
The new MDCG 2022 direction archive looks to explain how developers can recognize the right regulatory structure for these alleged \”borderline cases” by giving clear depictions of different sorts of item and making sense of how the vary.
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