If you are not aware about the CE mark, you either are not an exporter to the European Community or just finished dealing with a major FDA inspection which resulted in a Warning Letter and you had nothing on your mind but figuring how to cope with this pounding migraine headache. All kidding aside, if you have not come to terms with how to put the CE mark on you medical device, you will have a hard time getting your medical product into the European Community starting this June 14.

From the companies that visited our booth at the recent MDM convention in NY at the beginning of this month, there weren’t many companies who requested assistance in putting the CE mark on their products. It appears that most of the companies that knew they would need the CE mark have already accomplished this task, while the other are taking a wait and see attitude.

The funny part is that what is happening to the smaller US companies who can’t afford the price of what it costs to put the CE mark on their product is also happening to the small medical device manufacturers in Europe. They too have found it to expensive to put the CE mark on their products.

Apparently, from my discussions with various Notified Body auditors and other Europeans I have worked with recently, they feel that there will be a real problem in the short term for propriety medical products. The smaller companies who can’t afford the cost of putting the CE mark on their products usually supply these types of products. It would appear that the CE mark requirements would put them out of business. The loss of competition could ultimately increase the cost of medical products.

Recently, many US companies have contacted mdi asking how they could put the CE mark on their products. Once the Medical Device Directive is explained along with the cost and time ramifications, these small companies have to re-evaluate whether selling to their European customers makes financial sense.

The information that I have received is that most of the European countries don’t have the enforcement staff set up to even monitor the imports to check for the CE mark. It could several months before there is any real enforcement. But, the customer is the forcing the issue. For the most part most, importers will not take shipment of product without the CE mark.

It appears that the liability of using a medical product without the CE mark is of some concern to hospitals and doctors, though product liability is not the major issue that it is here in the good old USA.

Another item of interest is that many other countries, like those in South America and Asia are requesting that the products have the CE mark. If you remember correctly, it used to be that these same importers used to want to see if the medical product had a 510(k). It appears that the FDA may have missed the boat on this on. You see, the 510(K) cannot be used as advertisement on the product or the product literature. But, as you know, the CE mark is supposed to be on the product. So it is a lot easier for someone to see the CE mark on a product than to have to request additional documents, i.e. the letter of Substantial Equivalency when purchasing. Hence the request from these countries that the product have a CE mark.

But, not like the EU, there is no legal requirement for the CE mark and no legal ramification for incorrectly putting the CE mark on a product. This should be interesting to follow.

So to you, the medical device manufacturer who has successfully and legally put the CE mark on your product, congratulations. To the other of you who couldn’t get your act together or more probably the finances together, remember, the US market still makes up over 50 % of the world’s medical sales and who wants to sell to Europe anyway.

And a little side note, I was just recently informed by a very good friend from the US Embassy in Germany that some of the European Communities participants, foremost, France, does not think that the CE mark documentation is enough to assure the safety and efficacy of the medical device. France may still want medical devices to be submitted to their Government Agency for approval. Well, wouldn’t that be cause for concern. What if all the countries started to require this additional review? Where would it leave all those companies who work diligently to meet this requirement? Unfortunately, we could only wait and see how the EU will work this out. As soon as I learn anything more about this it will be posted.

The next INSIGHT REPORT will be: