An MD&DI September 1997 Column
Understanding CE regulations poses a challenge even to Class I manufacturers.
Most U.S. manufacturers are now aware that after June 13, l998, all medical products distributed in Europe must bear the CE mark. As the deadline draws closer, however, many are finding that they are not as prepared as they had thought and that requirements that initially seemed clear are in fact quite muddled. For example, many suppliers on both sides of the Atlantic were led to believe that ISO 9000 certification would automatically allow them to affix the CE mark to their products, but this is simply not true. ISO certification only supplements and supports an assessment of conformity to the Medical Devices Directive (MDD), which must be performed by a certification body appointed by the EU member states. Based on this misconception, however, numerous manufacturers paid for ISO certification services from registrars that were not accredited as notified bodies, and they are now discovering that they are not necessarily eligible for CE marking privileges.
To qualify for the CE mark, manufacturers of Class IIa, IIb, and III devices must be certified by a notified body to Annex II, V, or VI of the MDD (also known as 93/42/EEC)1 and comply with the essential requirements of the directive. Manufacturers of active implantables and IVDs have separate directives to contend with. When auditing for compliance, the notified body will check a number of items in addition to a manufacturer's QA system, including technical files, sterility assurance measures, subcontracting procedures, recall and vigilance systems, and declarations of conformity. Depending on the classification and certification route, some devices will also require an EC-type examination or a design review by the notified body.
Manufacturers of Class I products, who require minimal interaction with a notified body, appear to be the clear winners in this scheme, but even they must deal with a number of vague or confusing requirements (see sidebar below). Simply classifying their products according to the dictates of 93/42/EEC, Annex IX, can be a tricky affair, and faulty classification can lead to bigger problems. The simplified flowcharts in Figure 1 should help manufacturers determine whether their products qualify as Class I devices. For more difficult products, manufacturers may need to refer to a consultant or obtain a suitable software program.
Figure 1. Example of a medical device classification flowchart.
Contrary to common belief, classification is based on the intended and declared use of a product, not solely on its salient features. The Class I designation usually--but not always--excludes sterile products and measuring devices that measure physiological parameters or require a high degree of accuracy. So, for example, a reusable scalpel is Class I, but a sterile scalpel is Class IIa; a scalpel blade for the reusable device is Class I, but if it is supplied sterile, it is Class IIa. A stethoscope, a simple graduated syringe (not for injection pumps), and a measuring spoon for administering an expectorant are not considered measuring devices, although a hand-driven blood-pressure gage and a digital thermometer are.
All of the classification rules are included in the directive, but they're not easy to understand. Fortunately, an EC working group has drawn up a separate paper known as MEDDEV 10/932 to explain the rules and provide some practical guidelines. For example, the directive stipulates that reusable surgical instruments belong in the Class I designation as long as they are not intended for more than an hour of continuous use. According to this definition, items such as scissors and tweezers, even if they are used in a six-hour operation, are still considered Class I devices because they are not used continuously during that time.
Even if a Class I product is supplied sterile, the manufacturer must issue a self-declaration of conformity. In this case, the manufacturer need only certify the QC system governing those aspects of manufacture concerned with securing and maintaining sterile conditions. If the device is packaged and sterilized by a company that works with a certified process, then the manufacturer must only validate the process for the particular device and submit the results to a notified body. The manufacturer still needs certification by a notified body in regard to the performance aspects relating to sterility and measurement function; the notified body will also want to inspect the manufacturer's facility. Nonetheless, the procedure is far less complicated than a full production audit.
All manufacturers applying for CE marking privileges--including manufacturers of Class I devices--must prepare the proper technical documentation; appoint a "responsible person" within the EEC; design product labels and labeling according to 93/42/EEC, Annex I, paragraph 13; and sign a declaration of conformity. The technical dossier should not pose a major problem for manufacturers familiar with device master files. A list of required dossier contents is given in the sidebar on page 88. For biological material testing, Europe uses the ISO 10993 (EN 30993) protocols, but test results according to the Tripartite agreement (or USP XXIII) are accepted. Every electrical device must also be proven to comply with the EMC requirements defined in the MDD; suppliers of preassembled electrical components may have the appropriate test results already available. Reformatting an existing device master file is not necessary, only creating an index that cross-references the essential requirements of the directives with the device file contents. The master file is a controlled document, as defined in ISO 9000, and manufacturers would do well to regard it as highly confidential.
WHAT PRODUCTS ARE CLASS I?
The classification of a product refers to its intended use. The following is a simplified listing of Class I products.
- Noninvasive (and nonactive) devices that do not modify the biological or chemical composition of blood or liquids intended for infusion; store blood, body liquids, or tissues for administration; or connect to an active medical device.
- Dressings intended only as a mechanical barrier or for absorption of exudates.
- Invasive products for use in natural body orifices and stomas for no longer than one hour or in the oral or nasal cavity or ear canal for up to 30 days.
- Surgical invasive products if they are reusable instruments and not intended for continuous use of more than one hour.
- Active devices that administer neither energy nor substances to the body nor are made for diagnosis.
Class I products cannot:
- Incorporate medicinal products (drugs) or animal tissue.
- Be intended for contraception or the prevention of sexually transmitted diseases.
The technical dossier is closely linked to the responsible person, a representative in the EEC governed by European law and authorized by the manufacturer to oversee routine regulatory affairs. Specifically, the responsible person must ensure compliance with the European vigilance system, which covers both postmarket surveillance and adverse-incident reporting. For example, if a patient were injured by a device, or if a patient would have been injured had the caregiver not intervened, the responsible person would have to investigate the incident together with the device's manufacturer and file a report with the competent authorities. Moreover, the European authorities must be able to obtain the master file in case of trouble; therefore, the manufacturer must either store the file or its abbreviated form with the responsible person or draw up a contractual agreement that gives the agent the right to access the master file without delay if required by the authorities. The agent must be available all year, as the time frame for notification could be as short as 10 days. Ideally, the responsible person should be familiar with the national regulations in all member states.
For many manufacturers, the simplest way to maintain a European address will be to appoint a distributor as their responsible person, although this course is not without potential problems. The selected distributor does not need certification as long as the manufacturer's name and CE mark are on the product labeling. The name of the responsible person must also appear on the label, package insert, or outer packaging, even if the product is sold by a completely different distributor in another country. There is no official rule or proposal regarding how many responsible persons a manufacturer should have, but each one must appear on the labeling; therefore, appointing more than one is of limited use.
CONTENTS OF A DEVICE MASTER FILE
1. EC declaration of conformity and classification according to Annex IX of the MDD.
2. Name and address of the manufacturer's European responsible person.
3. Product description, including:
- All variants.
- Intended clinical use.
- Operating instructions/instructions for use.
- Photographs highlighting the product.
- Photographs highlighting the usage.
- Brochures, advertising, catalog sheets, marketing claims (if available).
4. Product specifications, including:
- Parts list, list of components.
- Specifications of materials used, including data sheets.
- List of standards applied.
- Details of substance(s) used (in the event of drug-device combination).
- QA specifications (QC specs, in-process controls, etc.).
- Labeling, accompanying documents, package inserts (DIN EN 389, prEN 980).
- Instructions for use (prEN 1041).
- Service manual.
5. Product verification, including:
- Testing data and reports, functionality studies, wet lab or benchtop testing.
- Materials certificates/reports on biological tests.
- EMC testing and certificates.
- Validation of the packaging/aging studies.
- Compatibility studies (connection to other devices).
- Risk analysis (DIN EN 1441).
- Clinical experience.
- List of requirements (Annex I) indicating cross-reference with documentation.
The responsible person should be selected with great care; device master files must be made available to the responsible person in the event of patient injury or near injury, and many distributors are potential competitors. Class I devices, by nature, will rarely lead to patient injury, but manufacturers should still consider labeling issues when choosing a representative. It's easy to change distributors, but changing the responsible person means changing all the product labeling. As an alternative, manufacturers can contract with a professional agency to serve as a representative completely independent from any distribution network.
The issue of labeling is itself a source of contention. Not all countries have decided yet whether they will insist on having their own language on device labels. Many countries have rather imprecise rules, dictating that their national language must appear only if necessary. Manufacturers can reduce potential troubles by using the pictograms and symbols
defined in the harmonized European standard EN 980. For instructions of use, manufacturers are advised to use all 12 languages used in the European Economic Area. The requirements for labeling are presented in Annex I, paragraph 13, of the MDD; some devices may be subject to additional requirements outlined in product standards.
Class I products fall under the jurisdiction of local authorities, but who serves as those authorities may differ from country to country. In Germany, for example, there are no clear-cut regulations that define the competence of the local authorities, except in the case of danger to the patient. European product liability laws more or less give the consumer the right to sue anybody in the trade chain. Normally, claims would be filed against the manufacturer, but it is possible that there will be claims against a responsible person. This is a rather new legal situation, and the rules will be determined by court decisions. It is hoped that Class I products will not instigate many court actions, but clearly, even manufacturers of Class I devices will have a host of new concerns under the CE marking scheme.
1. Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, Official J Eur Communities, 36 (July 12): 1, 1993.
2. "Final Draft Guidelines on Medical Device Classification," MEDDEV 10/93, Brussels, European Commission, October 1993.
Hans Haindl, MD, is a medical device consultant in Germany. He heads the scientific advisory board at Medical Device Safety Service (Wennigsen, Germany), a company that provides the services of a responsible person for Europe in accordance with article 14 of the MDD.
Illustration by Warren Gebert