The New Approach was unveiled by the Europeans in the 1990’s to great fanfare and expectations. This scheme is a methodology for industry and government to work hand in hand: Government sets expectations for product safety and the standards process fulfills them in a straight-forward way. However, now that we’ve had a couple of decades of experience with that system, some unforseen developments are occuring. Let’s take a look at the New Approach. Is it working?
In the main, the concept behind the New Approach is admirable. It provides legislators with a tool to set the bar for performance of products and services in the European Union. And it provides a mechanism, through the use of standardization, for industry to have a clear path to meeting these legal requirements.
So what could possibly go wrong? One of the things that I worry about is the limitations of the system made apparent with the addition of the Z Annexes. Since I’m familiar with the Z Annexes because of the standards for the three medical device directives, I see them as an admission that the standards have fallen short of the goal. To me these Annexes show you that standards developed to meet the Essential Requirements of particular directives may, in fact, not meet them entirely.
Now I do understand that the Z Annexes cropped up as a result of the changing concept of risk management, so perhaps this judgement is a bit harsh. But there ought to have been a review process in there somewhere that would have flagged this issue in a different way than as it occurred.
The New Approach system was set up so that legislators would set specific expectations for performance (the Essential Requirements). And by handing those requirements to standards developing organizations (CEN and CENELEC, and to a lesser degree, ETSI), industry and the national standards bodies would respond by providing harmonized standards. These standards would allow industry to meet the Essential Requirements by meeting the standards. It’s unfortunate that this system has fallen short in this particular case.
Another area for concern is the use of the national adoption system for acceptance and publication of EN standards. A couple of thoughts here. First, national adoptions allow for national differences. It is a mighty task to keep track of those differences, even with the tool that NIST provides (as a support to WTO barriers to trade activities). Secondly, it is confusing to have so many editions of any given standard. Non-European standards users are lost at sea when it comes to deciding which one is the best choice for them.
Of course, there is one last problem. Standards can be victim to political needs and that is certainly a concern in the European Union where the economic requirements of the individual states come into play. I understand that when the CEN CENELEC system first was instituted, that the technical divide between the member states were resolved not only by best practices but also by political will. I am not fully convinced that politics are out of the picture now that the first hard years of consolidation have been achieved.
Here in the U.S., EN Standards are an important part of the standardization requirements for our global companies. We value the role these standards have come to play in allowing for the development and distribution of safe and economic products around the world. So we have a stake in the outcomes in Europe, with the New Approach system and the use of the resulting Harmonized Standards. We look forward to the resolution of some of the technical issues that have disrupted the system.
And in spite of some of the limitations noted above, the New Approach is working well in the main. Many of the differences found previously within the states that make up the European Union have been eliminated by the use of the EN standards system. So while there have been concerns over the years with this new process, we’ll have to give it high marks for improving the ability of companies to do business with and within the EU.
