26/27 January 2021
At the end of 2012, the International Medical Devices Regulator Forum (IMDRF) replaced the Global Harmonisation Task Force which had been in charge until then of the worldwide harmonisation of requirements for medical devices. In August 2013, we reported in a GMP News about the current stand of the IMDRF activities with regard to the publication of documents.
Since then, further documents from the IMDRF have been released:
Recently, the IMDRF has published two informative documents about the topic "authorisation". The first document (RPS Beta Testing Document) informs about the electronic submission of medical devices. The second document entitled "Points to Consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS" also addresses the question of electronic submission and amends two final documents providing information about the authorisation of In Vitro Diagnostic (IVD) and Non-In Vitro Diagnostic products (see below).
Procedural Documents from the IMDRF are also something new. These documents include - among other things - terms of reference, an SOP about the IMDRF (e.g. memberships, documents release, IMDRF presentations). All these procedural documents (terms of reference, presentation and document templates) contain information about how to uniformly communicate with the outside.
By the end of last year, regulatory requirements on auditing organisations conducting audits at medical device manufacturers were amended with competence and training requirements and published as finale documents. In addition, a Unique Device Identification (UDI) guideline has been released as well as key definitions about SaMD (Software as a Medical Device - please also see our GMP News from 3 September 2014). Just recently, in August, information about the authorisation of In Vitro Diagnostic (IVD) and Non-In Vitro Diagnostic products was published. Both documents will be supplemented by the informative "Points to Consider" document mentioned above.
The "old" GHTF documents can still be found on the IMDR website. The currently applicable IMDRF documents can be found here.
Conclusion: The publication of IMDRF documents seems to take quite a long time. For that reason, it is appreciable that the old good GHTF document still can be found in the archives.