What's cooking at IMDRF? UDI and software, among other things
After the GHTF had been decommissioned – much to the disappointment of many – the IMDRF had big shoes to fill and everybody is watching if they manage.
The outcome statement of the last meeting in Nice, France of 19-21 March gives us a peek into what is happening.
The new work items were interesting to me. IMDRF will start work on international harmonization of the approach to standalone medical device software and on the definition of common data elements describing medical devices through the regulatory lifecycle. As you know, the EU is currently revising its standalone software guidance, the Swedes are on the game to hijack that process, the EU is also working on a Green Paper about health and wellness apps, the EN 62304 standard is by now starting to get really outdated and the FDA is still fighting with everybody else about what it will do in mobile medical medical apps. What better way to sort this all out than with some good international harmonization? The market for medical software as standalone software or as deployed in eHealth, telemedicine or mHealth is extremely international and will benefit greatly from harmonisation, so my applause for the initiative! I’m very curious how it will turn out.
There was also unanimous support on the importance of involving the medical profession in the IMDRF work, very nice. Hopefully the medical profession will get enthusiastic about being involved in devices vigilance, because this is one of the big gaps in EU medical devices regulation that also the new proposals won’t fix because they also only ‘encourage’ healthcare professionals to play a role.
The big problem with UDI in the EU is that we have placeholders for it in proposals that may enter into force years from now and implement UDI in stages, while we are waiting for the Americans. With that in mind, this is a situation that the IMDRF is supremely well positioned for to advance. And it does: it reports that “[t]he work on the revised Unique Device Identification Draft Guidance 2.0 on labeling specifications is progressing. A public consultation is envisaged in the near future.” When that will be we don’t know, but we do know that the FDA is planning to, by 30 November 2013, as a member of the Unique Device Identification (UDI) Workgroup, present to IMDRF Management Committee a draft IMDRF guidance document on UDI to update the September 2011 Global Harmonization Task Force (GHTF) document entitled “Unique Device Identification (UDI) System for Medical Devices. In the mean time the European Commission is also jumping in the fray with its own UDI recommendation, which was published on 9 April 2013. This recommendation says it’s “aligned” with what is happening at IMDRF level, so there you are on this point – this is were the IMDRF seems to be going (according to the EU that is), and more or less where the FDA will need to end up to with its IMDRF proposal in November (if it wants the EU on its side).
Hopefully the EU member states will also have the patience and sang froid to not run in all directions and start to impose their own UDI systems that will turn out to be incompatible with the Eudamed cathedral that the Commission is only starting to build and that will contain the EU UDI system envisaged under the proposed medical devices and IVD regulations.
The IMDRF announces that a consultation will be forthcoming with respect to its UDI draft guidance 2.0 “in the near future”. Watch that space, because I don’t really know what ‘near future’ means to a slow moving organism as IMDRF.
Ongoing work items
The outcome statement finally summarises the state of the ongoing work items:
- “The survey of the National Competent Authorities Report exchange program is completed. It was decided to review the GHTF N79 Guidance taking into consideration the outcome of the survey. A new proposed work program will be prepared with a view to the finalization of the revised guidance by the end of the year.”
- “The work on the revised Unique Device Identification Draft Guidance 2.0 on labeling specifications is progressing. A public consultation is envisaged in the near future.”
- “The documents on the Recognition for Organizations undertaking Audits of Medical Device Manufacturers and the Auditor Competency and Training Requirements will be submitted for public consultation with comments due by 15 June 2013.”
- “Discussions on the work item on the list of recognized standards continue to progress. The project should be completed by end of summer 2013. A work package for the second phase will be outlined for consideration.”
- “Regarding the Regulated Product Submission working item, the Management Committee endorsed the work achieved so far, including the completion of the draft non-IVD Table of Contents for marketing authorization as well as progress on the testing of the RPS standard for medical devices. The draft Table of Contents will be submitted for public consultation in the near future.”
There you have it: international harmonisation in action with interesting things in the pipeline. Good to see the IMDRF picking up momentum.