IMDRF Feb/Mar 2012 Meeting - Outcome Statement

[Ronen E]

Hello all,

Not sure whether or not this was already posted, but for its importance I'll take the risk of duplication

The outcome statement of the above meeting can be found at http://www.imdrf.org/pdf/imdrf-meeting-120228.pdf

(IMDRF = International Medical Devices Regulators Forum; the GHTF's "successor")

The statement sheds some light on future trends in global harmonization of medical devices regulation. I think there are a lot of interesting issues in the statement, and some of them are between the lines...

To my personal disappointment (as a RA specialist dealing a lot with premarket submissions, in various reg territories), the suggested future work item "Standardized submission requirements for pre-market assessment of medical devices" (item c on the proposed items list), was not among the ones selected for progression. If anyone has some "behind the scene" info on the reasons, I'd be glad if you could share it.

The next IMDRF meeting will be held on Sep 2012 in Sydney, Australia. Unfortunately not all sessions are open to the public; the Open Stakeholder Session will take place on Wednesday 26 September 2012. Prior registration for this open session will be required, as numbers are limited - you could notify your interest to the IMDRF Secretariat at [email protected].

Cheers,
Ronen.

 

[Marcelo]

We've had a brief resume of the first meeting this week during the TC 210 WG 1 meeting.

In my understanding, the fact that the mentioned work was not forwarded in this meeting does not mean that it won't in a future meeting (this first meeting seemed to have a high-level approach as it was the first and people were still somewhat unsure of some things).

The item on medical devie single audit program was briefly discussed as it has heavy ties with the ISO 13485 revision - it's really a very good initiative in my opinion.

 

[Ajit Basrur]

I agree Marcelo - the single audit initiative is a great leap

 

[Ronen E]

We've had a brief resume of the first meeting this week during the TC 210 WG 1 meeting.

In my understanding, the fact that the mentioned work was not forwarded in this meeting does not mean that it won't in a future meeting (this first meeting seemed to have a high-level approach as it was the first and people were still somewhat unsure of some things).

The item on medical devie single audit program was briefly discussed as it has heavy ties with the ISO 13485 revision - it's really a very good initiative in my opinion.

Hi,

Thanks for this additional perspective. I hope you are right and that the standardisation of premarket submissions will be targeted at some point in the future; however, given the magnitude of this task I assume even if it started being addressed today it would have still taken years before industry could have benefited such standardisation, let alone when we don't know when it's going to begin...

Ronen.

PS NOT diminishing other important achievements and prospects...

 

[gramaley]

The IMDRF plan for a Medical Device Single Audit Program was explained as being a work item, but no details were given.

The irony of it all was that the IMDRF introduced this work item after a presentation was given on the already completed, single audit program developed by the International Accreditation Forum.

http :// www .compad. com.a u/cms/iafnu/workstation/upFiles/IAF__ISO_13485_0112.pdf. - DEAD (404) LINK UNLINKED

MDSAP is supposed to be an "accreditation system", but it didn't appear that anyone at the IMDRF understood what "Accreditation" means in the world of management system certifications.

One woman from Australia complained to Kim Trautman in the open session that it looked like the IMDRF was planning to build a single audit program from scratch, after the IAF had just delivered one that is going into full effect June 2012.

The good news is, there is a great deal more interest coming from Asia, and Australia's TGA has already moved to pick it up. There are 66 countries that have accreditation bodies working together at the IAF to enforce credible certifications, while exposing phony certs. All the regulators have to do is "recognize it" and they immediately are tapped into vast power of the IAF enforcment network and processes. This is the full time work of accreditation bodies, and the IMDRF needs it, badly. I have a feeling they will spend years creating another system of "accreditation" that is nothing more than a certification of an auditor. If this happens, it will not hold CAB ORGANIZATIONS accountable using regular accreditation assessments like what the IAF uses. Sorry to get so frustrated , but I was there in Singapore and some people that should listen, simply won't take the time.

 

[sreenu927]

GHTF has release a new guidance document on "QMS-Medical Devices-non conformity grading system for regulatory purposes and information exchange".
This is especially for auditing parties and regulatory bodies about non-conforming materials/products.

Regards,
Sreenu

 

[Ronen E]

Hi,

For those of you interested in global regulatory convergence (and the IMDRF in particular), I recommend the following presentation by Kim Trautman from the FDA:

http://xaviermedcon.com/medcon-video-gallery-iv/

Lots of interesting topics and some commentary that would be hard to find on more "official" sources.

Re. "single audit" - Don't hold your breath; the current work-item scope is extremely limited (though it is an important step in the right direction). However, regardless of IMDRF, multi-lateral agreements will hopefully allow single-audits for the USA, Canada, Australia and Brazil in the foreseeable future. Unfortunately the EU has not bought in yet

Re. "single submission format" - Not too much here either, but the good news are that contrary to my OP above this topic was not completely postponed and some progress (though minor) can still be expected in the foreseeable future. I did find her comment re. STED utilization by the FDA a bit odd, given the length of the "pilot" program (years and years) and the very low participation rate on industry's part (20-something submissions all in all).

Re. ISO 13485 revision - According to the speaker, it's not likely to happen before 2015 and is expected to be quite major (at least that's my take on "interesting"...)

Cheers,
Ronen.

PS to BSI for sending me the link to that webpage.

 

[sreenu927]

Hi All,

The next IMDRF Meeting will be held in Sydney, Australia, on 25 to 27 September 2012.

The Open Stakeholder Session will take place on Wednesday 26 September 2012. Prior registration will be required, as numbers are limited.

Registrations are now OPEN - Interested parties can signal their preliminary interest in attending the Sydney open session, by contacting the IMDRF Secretariat at [email protected]



Regards,
Sreenu

 

[sreenu927]

Hi All,

Find the attached outcomes of recently held IMDRF meeting.
The next meeting is in France, EU from 19-21 March 2013.

Regards,
Sreenu

 

[Pads38]

Had a quick look at some of those with the hope that we may actually be getting closer to the dream of global harmonisation. Some hope.

On recognised standards:

Out of the provided 727 standards there is no standard which is fully recognized by all participating regions/countries
There are 17 standards which are fully recognized by 4 out of 5
regions/countries