Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

There is a list of on going MDCG guidance documents being worked on at.  
Guidance - MDCG endorsed documents and other guidance (europa.eu)

The following guidance was listed as planned publication 2021 and I have been waiting for its release.   
However, the first week of April,  the list of documents "in works" was updatated and this document is no longer listed; it was removed and I have not seen it published yet.   Would anyone have any insight regarding if this indicates the guidance will be published soon or rather it has been cancelled? 

Any insight is appreciated.

It has been released as MDCG 2022 – 5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

https://ec.europa.eu/health/system/files/2022-04/mdcg_2022-5_en.pdf


------------------------------
Peninnah Wanjeri
Director
Boston MA
United States
------------------------------

Original Message:
Sent: 25-Apr-2022 14:33
From: Anonymous Member
Subject: MDCG ongoing guidance document_boarderline with medicinal products

This message was posted by a user wishing to remain anonymous

Hello,

There is a list of on going MDCG guidance documents being worked on at.
Guidance - MDCG endorsed documents and other guidance (europa.eu)

The following guidance was listed as planned publication 2021 and I have been waiting for its release.
However, the first week of April,  the list of documents "in works" was updatated and this document is no longer listed; it was removed and I have not seen it published yet.   Would anyone have any insight regarding if this indicates the guidance will be published soon or rather it has been cancelled?

Any insight is appreciated.