CE Marking: The First Steps in Successful Exporting to Europe

Rene van de Zande

Imagine that you work for a small or medium-sized medical device company with great products. Sales have been solid in the United States, but now you are curious about that small continent across the pond called Europe. Well, your curiosity is justified. Europe presents a huge market for American device manufacturers, and those companies that have made the effort to obtain the CE Mark mostly have found it to be a worthwhile endeavor.

Although Europe is referred to as a “small continent” in the previous paragraph, this description is only valid in terms of geography. As a market, Europe is a giant. Three factors make it a lucrative market for US companies:

    1. 450 million consumers within the European Union (290 million in the United States)
    2. An aging population (which is older than the US population) increasingly in need of medical care
    3. Exchange rate of the Euro to the dollar makes US goods a great value for European buyers (30% discount for Europeans)

Selling in Europe is not nearly as challenging or complex as it was 10 years ago. The expansion of the European Union from 15 to 25 countries in 2004 opened up new markets such as Poland, Hungary and the Czech Republic—many of which hold good potential but are still developing.

Most people who have been involved with devices know that the first step in getting access to Europe is to obtain a CE Mark. The purpose of this article is not to sell you on Europe but, instead, to tell you how to get there from a regulatory perspective. Let’s talk about how to obtain the coveted CE Mark.  

Step 1: Determine Classification

This is the first step, because the classification of your device will determine your route to compliance. The United States has three classification categories: 1, 2 and 3. Europe has five: Class 1, Class 1 Sterile/Measuring, Class 2a, Class 2b and Class 3.

Step 2: Implement a Compliant QMS

In spite of what most people think, it is not a requirement to implement a quality system that is ISO 13485:2003 certified. The Medical Device Directive (MDD) requires Class I sterile/measuring, Class IIa, IIb and III devices to meet the applicable quality system requirements addressed in Annex II and V of the MDD. ISO 13485 voluntary and can be applied as a tool to meet the MDD’s  requirements. As a result, most device companies wisely choose this tool—also because it is an internationally recognized quality standard and is required for Class II, III and IV devices in Canada.
 
Integrating ISO 13485 with your existing Good Manufacturing Practices (GMP) quality takes some effort but certainly can be done within three to 12 months, depending on the size of your company in terms of locations, personnel and resources. Note that Annex II and V of the MDD do not apply to Class 1 non-sterile and non-measuring devices, which can be self-certified.

Step 3: Complete a Technical File

Regardless of classification, you will need to complete a technical file (or design dossier, if Class III). The Technical File is similar to the 510k application in the United States and, therefore, a substantial document. It is designed to comply with the health and safety requirements stipulated in the MDD. One of the key components of the technical file is a documented risk assessment.

Step 4: Get Audited

Once you have implemented ISO 13485 and compiled your technical file, you need to have your quality system audited by a Notified Body. In the United States, the FDA conducts facility audits to determine compliance with GMP. In Europe, the Ministries of Health (MOH) collectively have outsourced this task to officially designated companies called Notified Bodies, such as BSI, Intertek, SGS, TUV and UL—all of which have US offices. You essentially contract one of these companies to conduct annual audits of your quality system and technical file.

Step 5: Appoint an AR

Europe requires that you have an official point of contact with a physical presence in Europe. This can’t be a PO Box! It has to be someone who is qualified to fulfill the role required of an authorized representative (AR).

The role of the AR is growing in importance with regard to its role in vigilance and postmarket surveillance. Competent Authorities are increasing their surveillance of the market, and inspection of ARs is becoming a reoccurring event.

Distributors can fulfill this role legally, but more are declining to do so because of the growing responsibility assigned to ARs. In addition, manufacturers realize the AR’s role necessitates that person having access to the company’s technical file and, thus, certain proprietary company information that may not be appropriate for the distributor to access.  

Step 5a: Register Your Products

This actually is only required for Class 1 devices and in-vitro diagnostics (some countries require registration for Class 3 products). Class 1 products need to be registered only with the competent authority (MOH) where your AR is based. The manufacturer or the AR can complete this task.

Step 6: Prepare a DOC

Regardless of the device’s classification, you must prepare a “Declaration of Conformity.” This is a legally binding document, printed on company letterhead, that says you meet all of the MDD’s requirements, as this has been transposed into the European country’s national law.

Class 1 non-sterile and non-measuring device manufacturers can “self-declare” their compliance. This means that the manufacturer does not need to be audited, as noted above, nor does it need any official approval from a European MOH. The company does need to prepare a technical file, appoint an AR and, of course, prepare a declaration of conformity.

Self-declaration is a tough concept for many companies to grasp, since they inherently want to see physical verification (ie, a printed certificate or listing on a government Web site) that they either have met the EU regulations or that devices are officially registered. No such database of CE Marked products exists yet, but it is on its way. The long-awaited European databank is anticipated to become officially operational in 2007. It is not yet decided what type of information will be included and who has access to this information.

Step 7: Affix CE Mark and Start Selling

Because any good program has seven steps, this step deserves inclusion. Obtaining the CE Mark for your device requires time and, sometimes, a substantial financial investment, but it gives your products a passport throughout Europe. You still need to determine the specific countries there that hold the best potential for your products and then find, screen and manage European medical distributors. That’s not as simple as attending a big trade show and signing up with the first big distributor that visits your booth—in fact, that’s the biggest mistake companies often make when getting started in Europe. The CE Mark should go hand-in-hand with solid market research to get a return on your compliance efforts.

Update on New MDD

As many of you are aware, the MDD  is undergoing changes. Earlier columns outlined these changes. As of press time, it was expected that the changes to the MDD would be voted on by the European Parliament in November, and if no changes were made, the final directive is expected to be adopted and published in January 2007. The directive then will undergo a 12-month period, during which all 25 EU members will transpose it into national law. Following this, there will be another 12-month transition period, after which all affected parties must comply.

Therefore, companies will be expected to comply with the new directive by January 2009. This date could be further extended if the European Parliament suggests changes this November.

Rene van de Zande is president and CEO of Emergo Group, a consulting firm that provides quality assurance, regulatory affairs and distribution services. Emergo Group has offices in the US, Europe, Canada and Australia. Rene can be reached at [email protected].