While everybody is focusing on the legislative process in the ENVI committee and (to a limited extent) on what the Council is doing, significant other developments are playing in the background.
Joint Immediate Action Plan
You may remember that as soon as the PIP scandal’s implications became clear, the Commission initiated the Joint Immediate Action Plan, which is intended to increase market surveillance and notified body oversight pending the adoption of the medical devices regulation and the IVD regulation.
The developments in the joint action plan are not that transparent, but a lot seems to be happening in the background.
The Commission representative mentioned during an ENVI Committee hearing that it was quite far along with its implementation. The heads of medical devices agencies (CAMD) met during the Irish presidency, and they also met with the heads of agencies of the medicinal products authorities. However, there was no press about the results achieved in the joint action plan. Currently the Lithuanian presidency is on the ball and has announced that healthcare in general and the progress on the Clinical Trials Regulation and medical devices proposals are a priority.
Some time ago I announced that the Commission was working on a recommendation on unannounced audits by notified bodies and an accompanying Commission regulation for implementation of unannounced audits by the member states, which happily chugged along. This is one of the steps in the joint action plan. This spring I had it on good authority that the recommendation was going to become public in May 2013, triggering the unannounced audits chapter in the notified bodies code. As we have become used to, that date was moved to end of July now, so end of this month. I have it – again – on good authority that this time the date will not be moved; let’s see.
The need to amend your contracts to the new situation in which critical subcontractors (outsourced production, critical parts) will however not change. Several of my clients have started this process in the mean time, not only because I am saying it’s a good idea but because they are do not want to be caught unawares by a surprise inspection that they cannot deal with, if only because their subcontractors have no obligation to cooperate.
Commission Staff Working Paper
Also in the works is a Commission Staff Working Paper setting out the concrete results of the inquiry that the Commission did as part of the joint action plan requesting the member states to set out what they have done and achieved to improve market surveillance following the initiation of the joint action plan. This is probably what was announced and planned for at the end of January at the Irish presidency.
Summer will be interesting
With all these things in the pipeline summer will be interesting. Make sure that your company engages on the unannounced audits instruments when they pass, because in any event in the notified body code there is no transitional period. More about this when the documents become public.
If you are interested in hearing a lot more about these developments and about the revision of EU medical devices law in general, the 2013 RAPS conference in Boston end of September will cover all of this this in detail with at least two sessions, with speakers from notified bodies and the Commission, and I myself. This conference is unique in that it features speakers from Europe that are otherwise very difficult to speak to in person, so if you want the inside from the insight – be there.