Originally published October 1995
Robert S. Seeley
Lisa Hofmann-Zellerman, president of Accurate Surgical Instruments Corp. (Toronto), puts it bluntly: "You need CE marking if you want to survive and export."
Communauté Européene (CE) marking essentially stamps a company's passport to the European Union (EU), a market of over 300 million consumers. For device manufacturers, it is a one-stop approval that supersedes the more expensive process of seeking separate approvals from individual countries, with their varied regulatory requirements. From the EU's perspective, the goal is to harmonize national standards and bring products into the European market faster.
The advantages of CE marking are clear; the problem arises in obtaining it. Large device companies, which usually staff a full regulatory affairs department, have a firm grasp of CE marking. But many small device companies are confused: They are uncertain of what is required to obtain CE marking for their products, intimidated by its documentation burden, and wary of its costs.
It is particularly difficult for small companies to prepare for CE marking because they usually lack the time and personnel needed for the sizable documentation tasks involved. "Beyond the costs of the notified body, the energy and effort a small company has to put in to meet the requirements of the standard can be discouraging," says Paul Brooks of the British Standards Institution (BSI; Vienna, VA). Not surprisingly, many small companies put off getting CE marking - unwisely, say experts.
How much work a company must do to gain CE marking depends on the types of products it manufactures and the CE marking assessment route it chooses to take. For each product class, the EU Medical Device Directive, which took effect in January, provides several different routes through which the notified bodies can certify for CE marking (see Table). These bodies reside in Europe but usually maintain offices in the United States, from which they conduct their conformity assessments. A manufacturer must select a notified body to declare the company's eligibility for CE marking to a competent authority, a body appointed by an EU member state to carry out the requirements of the Medical Device Directive and monitor the activities of the notified bodies.
Compliance with good manufacturing practices (GMPs) puts a device company 70-75% of the way toward ISO 9000, which amounts to approximately 40% of the work needed for CE marking. And the revised GMPs, slated to come out in mid-1996, will bring device companies even closer to meeting CE marking requirements. By requiring a full (or more complete) quality system, the new GMPs are designed to harmonize with the ISO 9000 series standards, EN46000 (the European standard for quality systems specific to medical manufacturers), and many of the CE marking requirements. EN46000 lays out additional requirements for medical devices for product identification, traceability, corrective action, process control, storage and packaging, and delivery. "I'm told the new GMPs will be 90% of what CE marking and ISO 9000 represent," says BSI's Brooks.
Once it meets the standards required for ISO 9000 certification, a device company can often complete CE marking certification by itself. For companies that have already achieved ISO 9000, Brooks says, the additional requirements of a notified body to approve CE marking can be met for less than $5000.
The remaining steps between ISO 9000 and CE marking are covered by the EN46000 requirements, with the exception of two additional steps. Manufacturers must develop a vigilance program for reporting to competent authorities any serious incidents to patients using their device, and conduct postmarket surveillance to monitor less-serious problems. For higher-risk Class IIB and Class III products, companies must also consider the product-related CE marking requirements.
A company does not necessarily require ISO 9000 certification to receive CE marking, however. "Nothing in the EU Medical Device Directive says you need ISO 9000 certification for CE marking," says Glen Emelock, manager of the North American medical division of TÜV Product Service, Inc. (Danvers, MA), which is the U.S. subsidiary of a notified body in Germany. "TÜV has certified dozens of U.S. device companies for CE marking that did not seek ISO 9000."
Should a device company wait for the revised GMPs to seek CE marking? No, say those companies that have already obtained it. They warn that unexpected stumbling blocks can lengthen the process. "To wait for the revised GMPs to come out is silly," says Jean Goggins, PhD, director of medical and technical relations for Meadox Medicals, Inc. (Oakland, NJ). A medium-sized manufacturer of woven and knit vascular grafts and catheters, Meadox is one of several device companies that started early, and did the preparatory work toward CE marking certification themselves.
"We stumbled over quite a few things we didn't anticipate early on," Goggins says. One problem they encountered was that no European or international standard exists for vascular grafts. To solve the dilemma, Meadox Medicals worked with its notified body to cite the Association for the Advancement of Medical Instrumentation (AAMI) standard in the United States for vascular grafts. "Standards to support the directive are continuously evolving," says Patricia Christian, Meadox Medicals' manager of medical and technical relations. The company learned later that ISO will probably adopt the AAMI standard.
According to Goggins, the most expensive aspect of CE marking is the time staff members spend assembling and writing the required documentation. "Over the past three years, documentation tied up 30% of the annual workload of two staff members in Europe, Ms. Christian, and me. It also consumed considerable time and resources from R&D and quality assurance." Hidden expenses also creep in, such as costs for placing the CE mark on labeling and instructions for use. Labels need to be available in nine languages.
The time needed to change labeling and user instructions is another reason to start early. For Meadox Medicals, Accurate Surgical, and others, it took two to three years to achieve CE marking. St. Jude Medical (St. Paul, MN) also started early, and completed its CE marking and ISO 9000 documentation work for its mechanical heart valves in-house. The regulatory affairs associate at St. Jude who assembled the design dossier for CE marking and documentation for ISO 9000 concurrently says, "It took 100% of my time for several months. It was no small task."
The design dossier is a huge document that combines design and management information for Class III products. It describes the product, manufacturing and performance, design specifications and standards, results of risk and hazard analyses, design control, verification and validation techniques, and design processes. It involves clinical investigations, safety testing, and quality assurance. The notified body examines the design dossier to certify for CE marking.
St. Jude plugged a large amount of information from the product's premarket approval (PMA) application into the design dossier. The PMA contains much of the detailed clinical and manufacturing data that the Medical Device Directive requires for a Class III device. TÜV Product Service's Emelock says that a PMA provides about 70-80% of the design dossier's requirements for a Class III device when a company pursues full quality systems certification, as St. Jude did.
St. Jude began the CE marking process by working with consultants and attending seminars to learn about the process, including what the company needed to do to become certified. According to a regulatory affairs specialist who assisted St. Jude, preparing for CE marking was worth the effort and paid some extra dividends. "We have a better documentation system now. And we have the form ready as we put together another design dossier to obtain CE marking on a new product we're developing. The second time through won't be too bad." Hofmann-Zellerman of Accurate Surgical agrees, saying that her company benefited from writing down all of its procedures as part of CE marking. "It's also easier to involve the employees when they see the particulars in writing of why we must do certain things."
A good way to learn about CE marking is through the many seminars and conferences that notified bodies and consultants hold throughout the country. Trade associations also present educational programs, and companies are often willing to share their experiences. "There's a lot of free help out there," says BSI's Brooks.
For small companies that lack the resources needed to compile the documentation for CE marking, hiring a consultant is one alternative. Some notified bodies have support staff available to help small companies develop their documentation, allowing them to do more on their own.
Rather than assigning employees to the task, Accurate Surgical hired the consulting firm Information Mapping (Waltham, MA) to help prepare the massive documentation required for peritoneal implant catheters, considered Class IIB products under the EU's classification scheme. "I only have 10 employees, and I can't afford a full-time, $60,000-a-year regulatory person," explains Hofmann-Zellerman.
Including the costs of paying the consultant, the notified body that inspected the documentation, and the in-house labor involved, the company spent more than $100,000 to achieve CE marking. But, according to Hofmann-Zellerman, it was worthwhile. The company expects to win a $200,000 contract from a German firm that recently audited Accurate Surgical and its conformity to EU regulations.
Companies typically follow one of two routes to achieving CE marking: quality system assessment or testing and approving products. Those manufacturers that produce high volumes or wide ranges of products often select the quality system assessment approach. "The QA route sweeps a number of products under one approval," says BSI's Brooks.
Accurate Surgical pursued this alternative for its Class IIB product because of its high-volume production: the company sells some 50,000 peritoneal implant catheters per year. The notified body - TÜV Product Service, GmbH, in this case - assessed and certified the company's quality system from manufacturing through final inspection.
The alternative is to have individual products tested and approved. According to Brooks, product testing is good when a company produces a small range or low volume of products, such as magnetic resonance imaging scanners. Steve Gardner of Underwriters Laboratories (Northbrook, IL) argues that product testing can sometimes cost less than quality assurance assessment if, for example, a company has an in-house laboratory that has been certified, or if it bypasses ISO 9000 registration. Product testing may also be appropriate for high-volume components and subassemblies such as add-on personal computer boards for x-ray or cardiovascular monitoring, Gardner says.
Since it sells both Class IIB and Class III products, Meadox Medicals selected both the product testing and quality assurance certification routes to CE marking, says Goggins. "We decided to take both paths after talking it through with our notified body. We didn't want to gamble on a bad choice." She adds that Meadox Medicals created its design dossier for CE marking with data from its ISO 9000 certification, GMP program, 510(k), and PMA for sealed vascular grafts - even though the latter three do not specifically address European standards.
Meadox Medicals also benefited from a CEN document titled "Essential Requirements Checklist." The checklist translates the Medical Device Directive's essential requirements, which concern product manufacture, safety, and performance, into understandable language. "It helped us compile a checklist from which to develop our product dossier without confusion," says Goggins.
ISO 9000 WITH CE MARKING?
The decision to get ISO 9000 certification at the same time as CE marking rests with the device company, since the Medical Device Directive does not make ISO 9000 certification a prerequisite to CE marking. Accurate Surgical, like many companies going for CE marking, also had TÜV Product Service assess and certify it for ISO 9001 quality assurance. "It's better to get both done together. Otherwise we'd tie up people full time working on both, which would cost us more time and money," Hofmann-Zellerman says.
Achieving ISO 9000 also provides benefits unrelated to CE marking. A study by Lloyd's Register Quality Assurance, Ltd. (Hoboken, NJ), found that meeting ISO 9000 improves a company's management control, efficiency, and productivity.
But if a company can't afford to work up ISO 9000 and CE marking together, Emelock advises attaining ISO 9000 later, when profitability is sufficient to warrant the added expense. "Still, many companies find value in assessing for both ISO 9000 and CE marking for the most effective use of resources versus results," he says.
Depending on the product class, the size of the manufacturing operation, the volume of production, and the intricacy of the assessment, costs for ISO 9000 and CE marking assessments and certification range between $15,000 and $30,000, Emelock continues. The cost of annual follow-up audits ranges from $2500 to $5000, although auditing larger manufacturing systems that take longer to assess, and Class III products that require more detailed assessment, can cost more.
When there is less volume to inspect, the price falls. Ken Cogan, business development manager of Lloyd's Register, says a small company with fewer than 30 employees can obtain CE marking from a notified body for between $10,000 and $15,000.
In the end, Emelock says, "each company has to get to know the Medical Device Directive. Manufacturers must know the options available to make an informed decision about which certification route to take." He suggests sitting down with a few notified bodies "to find out their documentation philosophy, and come up with a CE marking solution appropriate for your company's size and budget."
With approval of the notified body and competent authority in Europe, the manufacturer is authorized to place the CE mark on its products. For device manufacturers, the mark eliminates many of Europe's national boundaries and the difficulties of complying with the various regulations of individual countries. For Europe, it opens the door to the vital products that North American medical device manufacturers provide to the world.
- "Essential Requirements Checklist," CEN/TC215, Document #N172, Brussels, Belgium, European Committee for Standardization, 1994.
CE marking classes and conformity assessment routes.
|I||Unpowered devices that do not penetrate the body. Least risk involvement with the patient.||Inspect technical file. Many companies will be able to assess and declare themselves, without a notified body.|
|IIA||Diagnostic instruments, and surgically invasive devices for transient and short-term use.||Review technical file and assess production quality assurance (QA) system or product QA system.|
Review technical file and test batches of product.
Assess full QA system for certain Class IIA products.
|IIB||Surgically invasive devices for short-term use, radiotherapy devices, and long-term-use or implantable devices.||Review technical file and type testing (inspect and test samples of product); assess production or product QA system.|
Review technical file and assess full QA system (i.e., all aspects of company's quality system).
Review technical file, type testing, and batch testing (every product or samples).
|III||Most risk involvement with the patient - contacts central nervous system or heart, or is absorbed by the body. Requires the most detailed documentation.||Review technical file and type testing; assess production QA system.|
Review technical file, type testing, and batch testing.
Examine design dossier, assess full QA system.
Robert S. Seeley contributes regularly to MD&DI.
(This article originally appeared in the October 1995 issue of Medical Device & Diagnostic Industry. © 1995 Canon Communications, Inc. All rights reserved.)