MDSAP Update: As Pilot Winds Down, Manufacturer Buy-in Still Lacking (Part 2)
In this second part of Emergo's analysis of the Medical Device Single Audit Program (MDSAP), we examine the current status of and challenges to the program as Australian, Brazilian, Canadian, Japanese and US regulators work towards implementation.
Part one of our MDSAP analysis is available here.
MDSAP Status Update & Challenges
Considering that we are now in the final year of the pilot, with only approximately seven months to go, and that the number of objectives and criterion that were not tracking well in 2015, is the IMDRF meeting its MDSAP objectives and criteria?
Of the 13 auditing organizations (AOs) in the program, fewer than 50% (six) have been authorized by the IMDRF to perform MDSAP audits. However, depending upon which RA is considered, the number of authorized AOs is even lower in some jurisdictions. For example, at the time of the March 2016 IMDRF meeting MDSAP audit reports issued by only the three (<25%) following AOs could be accepted by ANVISA:
- BSI Group America Inc. (Resolution RE 3454/2015)
- TÜV SÜD America Inc. (Resolution RE 80/2016)
- Intertek Testing Services NA Inc. (Resolution RE 859/2016)
And in December 2015 ANVISA had issued just a single GMP certificate based upon the outcome of the program.
That being said, in December 2015 Health Canada threw its weight behind MDSAP and announced that only MDSAP certificates will be accepted by Canadian regulators after 31 December 2018; the FDA has also announced its willingness to push on with the program.
Despite the IMDRF’s best efforts, there are a number of factors that are stacking up against the MDSAP, even at these closing stages of the pilot, which include:
1. Imminent regulatory changes in the European Union
With ISO 13485:2016 finally seeing daylight this year, it is only a matter of time (expected to be in the second half of 2016) that this standard will be harmonized by the EU just in time for the updated European medical device and in vitro diagnostic Directives. The regulatory burden for companies, in particular IVD manufacturers, is going to be dramatically increased with the publication of these regulations as self-declarations of conformity will mostly become a thing of the past. Furthermore, Notified Bodies including the MDSAP AOs are going to require a significant injection of qualified resources in order to perform the necessary auditing activities--an area in which a number of Notified Bodies are already struggling to deal with the requirement for unannounced audits.
On top of this, the future trend in Europe is for fewer, larger Notified Bodies. A number of these organizations, depending upon which markets they are in, will likely no longer accept medical device clients precisely due to a lack of resources.
These changes mean that there will be an internal battle for competing resources for MDSAP versus CE Marking audits.
2. Manufacturer participation in MDSAP
During March’s IMDRF meeting, manufacturer participation was identified as still being the primary challenge for the pilot at this point in time. As stated above, the target for the PoCC associated with manufacturer participation is > 10% of a candidate’s AO’s CMDCAS clients actively participating in the program. This relatively small target represents approximately 330 clients.
As of February 2016, 81 manufacturers were registered for participation in MDSAP, representing approximately 25% of the target and a measly 2.5% of AO CMDCAS clients. Health Canada’s effort to force manufacturers to provide MDSAP reports and the eventual qualification and participation of other AOs should go some way to reaching the target; however, it is likely that this would be after the December 2016 completion date for the pilot.
One of the factors making some manufacturers hesitant to adopt the MDSAP program is that at this stage there does not seem to be a sufficient cost/benefit argument to support the switch. For example, ANVISA will continue to charge for BGMP certification at the same rate as for manufacturers not participating in the program, and on top of that participants will be subject to an additional ANVISA processing fee for reviewing MDSAP audit reports. So at this point in time, MDSAP participants seeking BGMP certification are subject to a higher entry cost than manufacturers not participating in the program.
Clearly MDSAP is currently facing a number of challenges, particularly in regards to the imminent European regulatory changes and manufacturer participation. With a little over seven months to go, time is running out for the IMDRF to meet its objectives and criterion. And while Health Canada and the FDA are continuing to actively support the program, other actions, particularly those of ANVISA, are not giving manufacturers enough incentive to participate. While no city had yet been selected for the next IMDRF meeting in September 2016, it will certainly be interesting to see whether any substantial progress has been made in the program as it will be the final meeting prior to the pilot wrapping up.
Michael Dun is Country Manager for Emergo Austraila.