According to EDMA’s 2012 European In Vitro Diagnostics (IVD) Market Statistics Report, the in vitro diagnostics market in Europe has decreased 2.2% in 2012. These results had been predicted in the previous EDMA report released for 2011, given austerity measures to cut costs in health expenditure. However, a decline in revenue for IVDs might have bad effects in the health of Europeans: there is good reason to believe that governments should invest in IVDs when trying to save money in healthcare.
Caveat Emptor, or ‘Buyer Beware’, is a commercial rule favouring the seller, now largely extinct due to modern consumer legislation. But the European Parliament’s ENVI Committee, in its amendment on the reprocessing of single-use medical devices, has unwittingly slipped something similar back in again. Given the complex and highly technical nature of the Medical Devices Directives, I can see where busy MEPs would struggle to understand the details and consequences of this amendment, so I think it is essential that we take a moment to read the fine print.
Europe’s medical device industry has always agreed that Europe’s regulatory system for devices needs to be improved and has put forward various proposals to achieve this. In the wake of a case of fraud like the PIP breast implant incident, it is clear that we need a safer system that makes sure Europe’s patients continue to have timely access to the latest life-saving and life-enhancing medical technologies.
Getting the timing right for the implementation of changes is essential to ensuring that the new regulations result in a better system for IVDs rather than a bureaucratic quagmire. The sweeping changes being made to risk classification will be complex and time-consuming. The lessons learned from similar overhauls in other markets show us that a period of transition is essential to optimise the implementation of changes for the new European IVD legal framework.
The long anticipated revision of the Waste Electrical and Electronic Equipment (WEEE2) Directive (2012/19/EU) was published in the Official Journal, L197, on the 24th of July 2012. The Directive arrives just over a year after its sister Directive 2011/65/EU on the Restriction of Hazardous Substances (RoHS2). The stated aim of WEEE2 is to:
In summer of 2011, the EU's Central Management Committee’s (CMC) published “Decision No 3”, requiring the placement on medical devices of the full postal address of manufacturers and authorised representatives. Since then, Decision No 3 has had the European medtech industry scratching its head in confusion. As we see it, the adoption of the decision has already led to great legal uncertainty, and implementing it in its current form would serve only to increase bureaucracy and additional, unnecessary costs.