European Commission's Laurent Selles on Medical Device UDIs: 60 Second Interview
The FDA Final Rule on UDIs for medical devices is expected to be published in early August. Recently, the EU Commission announced their intention to take an internationally harmonised approach and follow the FDA's decision over here in Europe. Pharma IQ caught up with Laurent Selles, Deputy Head of the Cosmetics and Medical Devices Unit at the European Commission, ahead of Medical Device UDIs and Traceability, which takes place the 24th - 26th September, 2013 in Munich, Germany.
Pharma IQ: Unlike the measures taken in the pharmaceutical industry for serialisation, in which different countries have taken multiple approaches to regulations, the UDI initiative is attempting to tackle it on a global scale with international cooperation. How has this been achieved?
L Selles: It was achieved by the early decision of the FDA to go global… FDA realised before the other agencies that the issue of traceability should be addressed in a global manner.
Pharma IQ: And how practical is it to expect truly global standardisation?
L Selles: It is not practical in the short term, but this is the only route when we consider a long term perspective.
Pharma IQ: How will the EU Commission and FDA UDI regulations work together, and how will they interact in the future?
L Selles: The EU Commission and its DG SANCO Health and Consumers are committed to work hand in hand on this. There is also the political tail wind of the EU_US FTA looming.
Pharma IQ: Given that the proposed deadlines are staggered, some manufacturers may be thinking that they don’t need to take any action yet.
L Selles: Is this a fair assessment, It is fair to say that the Industry does not want to go too quickly , ahead of the regulatory implementation, and neither to lag behind.
Pharma IQ: And if not, what steps should medical device manufacturers be taking right now in order to ensure compliance?
L Selles: To be in synch with the regulatory developments is the key.
Pharma IQ: Are there any key warnings or pitfalls you would highlight to manufacturers at this stage?
L Selles: Yes… Do not develop your own UDI.
Pharma IQ: Finally, the latest word suggests that the FDA Final Rule will be published later this month.
L Selles: I keep my fingers crossed.
Pharma IQ: How far behind the US is Europe likely to be?
L Selles: For the labelling/marking? EU and the US will proceed at the same pace. Regarding the UDI Database, the US will lead by 2 or 3 years I would guess
Pharma IQ: When can European manufacturers, and then non-EU companies, expect regulations in their territories?
L Selles: In the EU: The ”Delegated act” which will regulate UDI should be adopted in 2015 (in practical application in 2016/17). The hard core will be to make the UDI DB (part of EUDAMED III) operational (up and running).
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