Recently I had a customer who was told that an EN standard that he uses had expired and he should start using the previous edition. Our client turned to us for clarification. I figured that the information was not correct. But of course, I researched it out because you never know… It turned out that the source of the information was a person new to standards. What was the real problem? Not understanding EN expiration dates.
Here at Document Center Inc. we have a number of tools that we use for understanding the timelines for adoption and migration to the various editions EN standards. And if there’s one thing that is always confusing, it’s understanding the EN expiration dates. This information is found in the Harmonized Lists, so let’s go to the Harmonized List for Directive 93/42/eec on Medical Devices.
Let’s scroll down until you get to the section labelled: Summary list of titles and references harmonised standards under Directive 93/42/EEC for Medical devices. This information is presented in tabular format, with a series of 5 columns of data and a separate row for each EN standard. Column 1 tells you which of the European Standards Organizations (CEN, CENELEC or ETSI) are responsible for each document. Column 2 is the document number itself and its title. Column 3 is the first publication date in the OJ, the Official Journal of the European Union, which is the date when the standard is officially accepted onto the harmonized list. Column 4 provides you with the information on what standard, if any, is replaced by the one in column 2. So this might be the previous edition, or it might be a similar document but one with a different number.
However, the confusion that many people run into is with the data in column 5 on the far right, “Date of cessation of presumption of conformity of superseded standard.” This is sometimes referred to as the expiration date. This date is not the expiration of the document in column 2. It is the expiration date of the standard in column 4. Thus, you use this column to see when you have to complete your migration from 1 document or edition to the next.
Why do they call this “cessation of presumption of conformity?” The harmonized standards have been developed specifically for a program called the New Approach. In this system, regulators request one of the European Standards Organizations to develop a standard to meet specific requirements of a directive. So for the List of Harmonized Standards for 93/42/eec, all documents on this list were prepared by a standards body specifically upon request of the regulators. These regulators then accepted the documents (after review) with the publication of a notice in the OJ (the first publication date mentioned above).
Now, the essential benefit of this Harmonized List and the New Approach is what’s called “presumption of conformity.” This is the concept that when you meet the requirements of a standard on the harmonized list, you meet the requirements of the applicable directive (in this case 93/42/eec). So if you can find a harmonized standard and meet it’s requirements, your product can be easily certified for sale within the European Union.
However, the list does change as new standards are accepted by the regulators, especially when new revisions are released. You, as a user of the standard, know that just because a new standard is available, that doesn’t mean that you can update your products and processes overnight to meet new requirements. How much time will you legally have? For the European Union, you’ll use the expiration date or cessation date as the time limit for compliance with the new material.
Is the cessation date always the date by which you must comply? In the note at the bottom of the table, you’ll see that in special cases additional time may be allotted.
Is publication on the Harmonized List always proof of conformity? Well, it used to be. However, as the system matures, there are a few cases when this presumption of conformity for some standards has been called into question. If this is a case for one of the standards you use, you’ll need to do additional work to “bridge the gap.”
Understanding EN expiration dates is essential to the proper use of these publications, but it can be confusing. Document Center Inc. is a trusted resource you can turn to for information and clarification of these types of standardization questions and issues. So not only can you purchase standards at our Document Center webstore at www.document-center.com, you can turn to us for additional services to improve the way you use your compliance documentation. We’re your Standards Experts!