SFL Informs Swiss Pharma Professionals Of The Importance Of Medtech Regulation For Future Drug Development
Presentations by senior staff of SFL on the EU regulation of medical devices and combination products drew a large and very interested audience at the recent conference in Zurich, Switzerland, organised by the Swiss Association of Pharmaceutical Professionals (SwAPP) and SGPM, the Swiss Society for Pharmaceutical Medicine.
- (1888PressRelease) November 29, 2011 - There were more questions than time allowed among the audience of 100 or so professionals who attended SFL's presentations at the 15th Joint Swiss Symposium on Pharmaceutical Medicine (SwAPP/SGPM). Attendees were from biotech and pharma, Government, contract research organisations, healthcare institutions and ethics committees.
While few of the delegates had been aware of how EU device regulations operated, the level of interest among the audience was high, especially since the EU Medical Device Directives (MDDs) also apply in Swiss law through the mutual recognition agreement that Switzerland has with the EU.
SFL Managing Director, Shayesteh Fürst‐Ladani and UK Office Head and Medtech regulatory expert, Amanda Maxwell, explained how an increasing number of drug companies are making use of device technology to optimize delivery of their products and gain a competitive edge.
Amanda Maxwell commented afterwards: 'It is always a little nerve‐wracking to explain how devices are regulated to a group who are used to the stricter drug regulatory regime.' Ms Maxwell explained how the device sector, with its short product life‐cycle could not sustain the longer and more costly regimes associated with drugs. She also emphasized the importance of postmarket surveillance in the devices sector where the premarket phase is neither as long nor as prescriptive as in the pharma sector.
There was some concern in the audience about the different approach, she explained. One delegate observed, for example, that given blood pressure monitors are low risk and do not need the involvement of a notified body, these products may present a risk to patients from poor calibration. This type of risk, Ms Maxwell explained, had already been thought of and addressed. Any low‐risk Class I device with a measuring function must have that measuring function assessed by a notified body.
Shayesteh Fürst‐Ladani, meanwhile, spoke about the increasing tendency for pharma companies to use medical technology for more successful delivery of their drugs, and increasingly in non‐hospital settings too. However, although the rules are present in the MDDs, they are not always clear on drug‐device combination products and are not mirrored in pharma legislation.
Indeed, there is a high risk of misunderstanding since EU pharma legislation (Directive 2001/83/EC) refers to some medical devices simply as 'containers', but this concept is absent from the MDDs where the requirements are addressed in quite different and more detailed terms.
'It is time for more clarity and consistency', she told the delegates, adding that the European Commission appears receptive to the position of the EU biotech industry association, EuropaBio, that there needs to be a review, particularly of the EU rules for drug/device combination products where the drug has the primary action.
'It will be interesting to see how the revised EU legislative texts on medical devices, due out in 2012, deal with this issue', she concluded.
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