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A CE Mark on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations. The symbol—an abbreviation of the French phrase “Conformite Europeene”—indicates to governmental officials that the product may be legally placed on the market in their country; ensures the free movement of the product within the EU single market; and permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities. Recently, the local manager of one of my company’s European subsidiaries put a shipment of spare parts on hold because they were not CE marked. A debate ensued on whether it is required or not to affix the CE marking on those spare parts and whether the components were indeed spare parts. There are two reasons why the company should affix the CE marking on components, the local manager argued. Firstly, our company risked being shut down by the country’s Competent Authority if medical “goods” were found on the market without the CE marking, which is required by the Medical Devices Directive 93/42/EEC. Secondly, another manufacturer was CE marking their components and our company would be at a commercial disadvantage if we did not mark ours. We looked at both aspects. Regulatory Requirements and Guidelines on the Application of CE Marking The Medical Devices Directive (MDD)1 and the obligation to affix the CE marking apply to medical devices and medical accessories. According to Article 1 of the MDD:
Following is a list of MEDDEV guidelines and NB-MED recommendations that address the subject of accessories and spare parts:
Although there is no official definition of consumables in the MDD and AIMD, it is generally accepted that consumables are articles with a lifetime shorter than that of the medical device, accessory or system they are used with and would require periodic replacement. For example, a complete respiratory mask system, including headgear, is an accessory to a CPAP machine; the air filter for the same CPAP machine is a consumable. If a finished medical product falls under the definition and scope of Article 1 of MDD or AIMD, then it must be CE marked. But if it does not and the manufacturer still affixes the CE mark on the product, it is likely that Article 18 of the MDD or Article 13 of the AIMD concerning wrongly affixed CE marking will apply. Is it a Finished Product, Raw Material or Component? According to MEDDEV 2.1/1, the important factor to consider when deciding whether a product falls under the MDD or AIMD is the medical purpose assigned by the manufacturer, and whether the product is a finished product rather than a raw material, a component or an intermediate product. A finished product with an established medical purpose must be CE marked and must have an EC Declaration of Conformity, in which the manufacturer makes the required statement of conformity of your product, according to the “EC-compliance route type A,” also referred to as the self-declaration route. This statement should be available to the authorities at the point of entry on the European Market. This means that it should be signed by the manufacturer’s European representative if the company resides outside the EC. Its main purpose is to show proof of liability for compliance with EC regulations involved to the authorities and customs. It should contain all the necessary information to determine:
Back to the previous example: a complete mask system is an accessory to the CPAP machine, but individual components of the mask and CPAP machine supplied separately for the purpose of replacing existing parts are spare parts. The carry bag provided together with the CPAP machine is an accessory too, but not a medical accessory. The CPAP machine and the mask system would have to be CE marked, but not the spare parts supplied separately. The same component or subassembly might require a CE marking or not, depending on the intended use declared by the manufacturer. For instance, if a manufacturer intends to market an electronic circuit board as a “generic” off-the-shelf article having a defined function available to the user without further adjustment or connections other than simple ones, which can be performed by a lay person, the circuit board would fall under the scope of the Electromagnetic Compatibility Directive 89/336/EEC and would have to be CE marked (see “Guidelines on the Application of Directive 89/336/EEC-Chapter 6 Application of the Directive to Components, Finished Products, Systems and Installations,” available online at http://europa.eu.int/comm/enterprise/electr_equipment/emc/guides/chapsix.htm). If the specified intended use for the same article is medical, it should be considered a medical accessory and CE marked under the MDD or AIMD, as applicable. If the manufacturer however sells the circuit board for the sole purpose of replacing an existing board inside a specified (medical) device, the conformity of which has already been established, the circuit board is a spare part and is not subject to CE marking. The MEDDEV and NB-MED guidance documents represent the official interpretation of the authorities in the Member States and their Notified Bodies of various aspects of the MDD and AIMD. While the MEDDEV and NB-MED guidelines do not have statutory authority, following them provides presumption of compliance with the Directives, in the same way that voluntary compliance with harmonised European standards provides presumption of conformity to the corresponding essential requirements of the EC directives. Manufacturers can double check whether the local Competent Authority agrees with the interpretations and recommendations expressed in these guidelines. A list of Competent Authorities is available on the official Web site of the European Union, at http://www.europa.eu.int/comm/enterprise/medical_devices/guidelinesmed/2_12_1annexgen2002.htm. Commercial Considerations The CE marking is addressed to the customs inspectors and market supervision authorities and not to the end user; therefore, it is a regulatory, not a marketing, mark. It is likely, however, that European end users—institutional or private—will check whether the CE marking appears on the label, because regulatory compliance is usually a purchasing criterion. The reasons for buying spare parts are different from those for buying finished medical devices and accessories. An end user will purchase a spare part in order to replace a broken or defective part in his or her existing device or accessory. Therefore, the purchaser will check whether the component is the correct spare part required, rather than whether it is CE marked or not. Alternatively, the user can send the defective device to an authorised servicing department for part replacement and repair, and in this case he or she is not directly involved in sourcing and buying the spare part. What can a manufacturer do when its competitor sells spare parts with CE on them and, worse still, if someone claims that spare parts without a CE marking are not compliant with regulations? The regulatory side of the question has been previously clarified, and the position of regulatory opinion leaders is that spare parts are not subject to CE marking. The manufacturer should be informed and be prepared to educate his customers if necessary. It is not mandatory to affix the CE marking on spare parts, but is it any harm in doing so? Manufacturers should be aware that every CE marking affixed on products must be traceable to a Declaration of Conformity signed by a responsible person with executive authority. The CE marked medical article must have a defined intended use. Other administrative measures might be required, such as registering Class I medical devices with the Competent Authority. Having separate Declarations of Conformity for various spare parts with potential additional paper work puts an unnecessary burden on a manufacturer, especially if the number of different spare parts supplied to service its devices goes into hundreds. Overheads add extra costs to the business and put the manufacturer to a commercial disadvantage. Conclusion Using the current guidance documents, the manufacturer should establish whether components and subassemblies sold separately are indeed spare parts. This means checking that:
NOTES:
Valentina Theisz, RAC, is the regulatory affairs manager of the Patient Interface Division of ResMed in Sydney, Australia. She has been a technical certifier and technology auditor for the application of QA systems for medical devices for TÜV Product Service in Frankfurt, Tokyo and Hong Kong. She has also been a QA manager for a start-up medical devices company in Sydney.
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