Countdown to the Medical Device Regulation – A LANSA Perspective
The changes happening in the medical device world over the next few years fall squarely into the category of “quiet revolutions that will affect us all.” The last time the European Commission updated and harmonised regulation across Medical Devices was in the 1990s – the huge leaps made in terms of technology would predicate some updating and tinkering to keep pace. The changes that are about to be implemented go far further than that and seek to put in place safeguards that will serve the population’s health needs for at least the next 20 years.
Together with Bsi (The British Standards Institution), LANSA once again proudly supported the ABHI (Association of British Healthcare Industries) at their industry event – “Countdown to the Medical Device Regulation,” which was held 30th September at the magnificent new offices of CMS Cameron McKenna in heart of the City of London.
As always the event was over-subscribed, re-enforcing the very high level of interest in the subject matter. A great selection of speakers created an engaging agenda that provided the audience with an up-to-date overview of the Medical Device Regulation. Sessions were delivered by:
- Johnson & Johnson
- Eucomed (The European Medical Technology Industry Association)
- CMS Cameron McKenna
- LRQA (Lloyd’s Register Quality Assurance)
- Ethicon Endo-Surgery (Europe) GmbH
- Terumo BCT
It would be impossible to reflect the detail of the regulation here, but from LANSA’s perspective, there was an overarching theme throughout the day; information about your products is as important as the product itself. Whether this be clinical evidence, information about the constituents of your product, commercial information, classification or master data; the quality of this information and how you share it (and with whom you share it) are central to meeting the demands of the unfolding regulatory landscape.
Many had arrived at the event expecting further detail on EUDAMED (The European Database on Medical Devices). To some this will be the EU’s version of the FDA’s Global Unique Device Identification Database (GUDID) but the European Commission clearly seeks to take the European database far further than the FDA have taken their identification database. The exact extent, scope and function of the EUDAMED database, however, remains uncertain.
Following many years of discussion it is hoped that the lack of clarity around simple questions such as “What is EUDAMED for?” and “Who will have access?” remain unanswered or, far worse, answered in different ways in the 28 European member states that will use the database. For manufacturers looking at a 2017 deadline for managing their data into this database, there is an urgent need for clarity and unity.
The Need for Clarity
This need for clarity can be illustrated by referring to a recent announcement by Brazil’s pharmaceutical regulator, ANVISA (Brazilian Health Surveillance Agency). At the end of September 2015 ANVISA announced that they were “suspending” at least part of RDC-54/2013, the declaration that mandated drug serialization and tracing, until further notice.
They had set hard deadlines of December 2015 and December 2016 for serialisation of some, and then all products. However, lack of clarity about the exact data requirements and responsibilities have led to them to suspending those deadlines, indefinitely. More information about this can be read on the RX Trace web site.
A very well attended event providing much needed updates on Medical device regulation in Europe. LANSA engaged with many participants requiring further clarification on the FDA UDI rule and how to prepare for next round of compliance for Risk Class II devices.