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.

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