The Role of Product Testing in CE Marking

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

Originally published August, 1996

Greg Freiherr

Except for the simplest of medical devices, such as tongue depressors and wheelchairs, there is no direct route to a CE mark--no easy way to win approval to sell that product in the European Union (EU). Many companies on this side of the Atlantic are being advised by consultants to seek certification of their quality manufacturing systems under ISO 9000 or EN 46000, certification that can cost hundreds of thousands of dollars. But quality systems certification in itself does not ensure a CE mark. Obscured by the political shadow cast by certification is a second process that is essential to obtaining the CE mark. When performed correctly--and strategically--this process can shorten the route to obtaining a CE mark and can cut the cost of getting a product to market in Europe. It involves testing products to obtain data that support the application for a CE mark.

Simply put, product testing ensures that a device presents no danger to the patient and end-user from a number of possible hazards--biocompatibility, electromagnetic compatibility, electrical safety, mechanics, functional safety, and performance. "There is a difference between FDA efficacy and the European approach to performance," says Victor C. Clements, vice president of international business development for Technology International, Inc. (Swindon, UK). "Europeans are not concerned about whether a product is beneficial--just that it performs as intended."

The product manufacturer determines which tests should be conducted based on the type of device. Clements explains that the product test plan is really a matter of common sense founded on a clear understanding of the product and its use. For example, an implantable pump would likely require data supporting biocompatibility, electromagnetic compatibility, and sterility, as well as addressing product safety issues. "There is no list or guidance for specific devices," Clements says. "It is up to the manufacturer to figure out."

But the manufacturer is not entirely alone. Notified bodies will review a preliminary test plan put together by a company. They may even recommend various approaches for testing. The best consultants will go even further, developing a complete regimen of tests in the context of a proposed quality system that fits the company's goals. "The first thing we do is try to understand where the company is in terms of its own operations to determine strategically which is the best way to go," says Donald F. Grabarz, managing partner of International Regulatory Consultants (Salt Lake City), a consortium of consulting firms in the United States and United Kingdom.

Use of a consulting firm can prove to be critically important to a company because of the myriad choices that must be made when pursuing a CE mark. Product tests, for example, might be done by the company itself in its own lab or in a nearby lab that specializes in the tests needed. In fact, a responsible company developing high-quality products is likely to have performed many of the tests necessary to gain a CE mark as a natural part of its product development.

But there is a catch. To be valid, test results must meet certain standards established by the EU. One way to establish that validity is for the manufacturer to conduct the testing according to criteria that meet the applicable EU directives--for example, the Medical Devices Directive and the Active Implantable Medical Devices Directive. Another way is for the notified body to send one of its engineers to the manufacturer's facility to do the testing. The German notified body TÜV Essen, for example, offers such on-site testing, with the balance of the investigations and submission of additional documentation done by phone, fax, or mail.

Unfortunately, there is no way for a company to know up front the preferences of any one notified body. "There is no formal structure, no one telephone number that anybody could call to find out," says Clements. "The best advice is to contact the notified body at the outset or get in touch with a medical device consulting company."

It is at this point that the product testing phase can become as daunting and laden with bureaucracy as the process for certifying quality systems. Each of the major players involved in quality systems certification plays a similar role in product testing. A competent authority, which is to a European country what FDA is to the United States, selects notified bodies--nonprofit organizations that issue CE marks for specific products. These notified bodies also audit testing laboratories to ensure compliance with criteria associated with the Medical Devices Directive--which includes by reference both the EMC and Low Voltage directives, for example--or the Active Implantable Medical Devices Directive. Labs anywhere in the world that have been and continue to be audited by a notified body can conduct testing for that notified body to obtain the data needed to support a CE mark application. Or the notified bodies themselves can conduct the tests. TÜV Rheinland, for example, offers two major test laboratories--one at its North American headquarters in Newton, CT, and the other in San Francisco. Smaller labs are located in cities throughout the United States.

When it comes to electromagnetic compatibility (EMC), the vernacular expands further to include competent bodies, which fall somewhere between notified bodies and testing laboratories. These competent bodies are essentially engineering firms that make technical decisions related only to the EMC Directive, explains Walter Poggi, president of Retlif Testing Laboratories (Ronkonkoma, NY). "You need the competent body in EMC because EMC is a generic directive and it can spread over a very broad product spectrum," he says. "It can apply to many types of products and multiple product families."

All these players come together on a global stage, acting out different roles under different circumstances. In product testing, notified bodies often accept data gathered by a company through the efforts of its own laboratory staff. "Our job is to review those data and go on-site and look at the systems that are in place," says Steve Anderson, director of the North American medical division for TÜV Product Service (New Brighton, MN). "We look at the way test equipment is set up and the way the data were procured. On that basis, we decide whether the data are acceptable." If the data were obtained from a laboratory hired to do the testing, the notified body may go on-site to do a quality systems audit to ensure that the laboratory is qualified and competent.

That can all be avoided, however, through a process called self-declaration. This process is the simplest way to obtain a CE mark. As might be expected, however, self-declaration can be applied only to medical devices that pose little or no hazard. These devices are usually placed in Class I, which is dominated by nonactive, unpowered devices that do not penetrate the body (although some low-risk powered devices are included in this classification). A company seeking a CE mark for such a device may choose to self-declare its compliance with the appropriate directives.

Such a declaration does not mean product testing was avoided, but rather that the laboratories doing the testing did not need to go through the process involving the notified body. In fact, self-declaring compliance means the company can skip the notified body entirely. Because Class I devices pose little hazard to patients, an error in the CE marking process carries few consequences. "When you get into a low enough class, they figure even if a company does something wrong, there is not that much risk to the patient," Anderson says. The only exceptions are if the device conducts some kind of measurements or requires sterilization, in which instances it is necessary for the product to be assessed by the notified body--but only according to the directives that apply to measuring devices or sterilization.

But just as self-declaration is the simplest method, so is it the one most prone to error. In rushing to obtain a CE mark, a company may not conduct all the tests necessary to identify hazards. If an incident then occurs with the device, the procedures and test data to support the self-declaration will be requested by government, and the company will be liable if an error was in fact made.

That is not a problem for the manufacturers of more sophisticated devices, such as those residing in either Class IIa or Class IIb (medium risk) or in Class III (high risk). Class IIa devices are generally nonhazardous active devices. If they are surgically invasive, their use does not exceed 30 days. Class IIb is composed of potentially hazardous active devices--for example, those transmitting x-rays, or surgical devices carrying higher risk. Class III devices contact the heart, vascular, or central nervous system, or are invasive for long periods.

When assessing these devices for the CE mark, product testing takes on added significance. It is the means by which critical questions about the safety of the device are answered to the satisfaction of the notified body. And just as there are many ways to test a device, so are there many ways to use product testing to obtain a CE mark.

Typically, data attesting to the safety of the device are submitted to the notified body as part of a design dossier, which is reviewed for completeness and validity. According to TÜV Product Service's Anderson, this dossier is a complete listing of all the test data--animal data, clinical data, and design description--that have to do with a device. If all the required data are not included in the dossier, the company has the option of conducting additional testing itself, having the notified body conduct the additional testing, or hiring an independent testing laboratory approved by the notified body.

But in such a circumstance, testing alone, no matter how rigorous, cannot in itself win a CE mark. Before issuing the mark, the notified body must be confident that the product tested is representative of the product being routinely manufactured by the company. This usually means that the notified body must then certify the quality system associated with the manufacture of that product. For medical devices, this entails certification according to EN 46001, a standard written for the medical device industry that includes a variety of components--including postmarket surveillance as well as design considerations found in the broader ISO 9001 standard.

Alternatives to undergoing a full-blown quality systems assessment exist, however, and may be especially appealing to companies that are trying to get a product onto the European market to test its marketability and that may not want to commit to a long-term investment in that product. In such a case, the company may have several options, depending on the risk presented by the device. If the device falls into Class IIa, the manufacturer can declare conformity to the applicable standards and then have a notified body audit only the manufacturing and inspection processes, says Clements. If it is a Class IIb or Class III device, the company must choose between going the full QA route with a certification of the quality system by the notified body or seeking what is called a type examination. "That usually means you give your device to a notified body, and they do the testing to make sure the device meets the standards that Europe has established," says Anderson.

One form of type examination involves 100% testing of the product as it rolls off the factory line; the other involves batch testing. The first form is most applicable to companies producing a low volume of units, perhaps a dozen or so per year. In that case, the notified body would test each unit to determine whether it meets the appropriate standards. The second route, batch testing, is based on statistical analysis. If, for example, 1000 units were produced, testing a batch of 100 might be enough to ensure that the product meets European requirements for the CE mark. "This provides an almost superimposed quality control system, statistically sampling the product as it comes off the production line," Clements says. It does not, however, free the company from the need for a quality system. It merely has a less-demanding quality standard to meet. Rather than complying with EN 46001, which includes design controls, the company using type examination would only have to meet EN 46002, which is specific to quality manufacturing and does not include design.

Type examination can be extraordinarily costly and time consuming, given the need for continuing tests. This is especially true in the United States. While many European-based laboratories consolidate a variety of testing under one roof, such laboratories are the exception in the United States. Here, labs tend to perform only certain tests, meaning that a device may have to be tested by more than one of them.

This is a concern not only when conducting type examinations but in all aspects of product testing, because notified bodies tend to accept the results of only those labs that they have accredited. Consequently, an American company could have its product tested at several laboratories to obtain data to cover the different requirements. Each laboratory may be an expert in its field, and each may be accredited by a different notified body, but when the time comes to present the data to support a CE mark for a product, only a portion of the data may be acceptable to the chosen notified body.

This underscores the need for strategic planning early in the process. By law, notified bodies are prevented from consulting with manufacturers. "In general, we will help them define what is required," says Reiner Krumme, division manager for medical devices at TÜV Rheinland of North America, Inc. "We can talk about all possible approaches and how to approach the conformity assessment procedures. That is public information. But we cannot do any kind of consulting."

That has led some companies to seek out consultants, who promise to guide the company through the process of obtaining a CE mark. One consulting firm that appears to be ideally positioned to provide that advice is Technology International, which is affiliated with SIRA Certification Service (South Hill, Chistlehurst), a notified body operating out of the United Kingdom. "We are being trained so we understand what their approach is so that we are almost transparent as far as the customer is concerned," Technology International's Clements says.

Technology International's parent company, Interference Technology International, Ltd. (ITI; Swindon, UK), is a competent body that conducts EMC testing. ITI has a similar affiliation with SIRA, a notified body under the Medical Devices Directive for certification of quality systems to EN 46000 and for product conformity within the biomedical and electromedical fields. In this role, ITI is a testing house that generates data regarding EMC and, as such, does not provide consulting to clients.

Nothing is simple when it comes to getting a CE mark, not even choosing a notified body to review the test data. Notified bodies are not all notified for the directives relevant to medical device companies, a fact that may not be apparent until after the notified body is contacted by the device company. Also, notified bodies may only be notified for some medical devices, such as passive or active devices, or invasive products.

Similarly, not all notified bodies even do testing themselves. The National Standard Authority of Ireland (NSAI; Dublin), for example, decided a long time ago against doing any product testing, and there appears to be no chance that it will reconsider that decision anytime soon. "We have too many other irons in the fire," says Richard Bernier, director of U.S. operations for NSAI. "This is just one scope of registration--we have the automotive requirement, the machinery directive, the low voltage directive, the EMC directive, everything." Bernier notes, however, that NSAI will accept test results from recognized testing laboratories.

Companies seeking permission to market their products in the United States do not have to contend with such concerns. FDA has not spelled out specific requirements for testing laboratories, preferring to focus instead on the methodology used to verify that the data are accurate and valid. FDA's steadfast adherence to that approach may benefit American companies elsewhere in the world, as international efforts aimed at developing mutual recognition agreements (MRAs) among global regulatory agencies would ensure that a product cleared for marketing in one country would be cleared for others that have MRAs in effect. "The goal of mutual recognition is that a European would be able to go to a European laboratory and have a product approved for the U.S. marketplace and vice versa," explains Poggi. If that happens, the confusion currently surrounding product testing might just disappear.

Greg Freiherr is a contributing editor to MD&DI.