CE MARKING - Too burdensome for small manufacturers?
With the support of highly capable regulatory affairs departments, large international medical device manufacturers experience little difficulty in complying with the complicated regulations governing the sale and distribution of medical products in Europe. Moreover, through their work with lobbyists and their contact with industry organisations such as the European Confederation of Medical Devices Associations (EUCOMED), they have the ability to influence, albeit indirectly, the legislative process, thereby ensuring that their concerns are addressed.
But what about small and medium manufacturers — the companies with sufficient sales volumes across the European Union (EU) to warrant its ‘CE’ certification but lacking a registered place of business or a subsidiary in any member state? These manufacturers without the same clout or resources at their disposal, will discover that their concerns are generally overlooked. In addition, these smaller manufacturers face difficulties with CE certification and registration not faced by their much larger competitors.
Certification and registration procedures often follows a similar pattern. The minimum requirement for CE marking is through the self-certification process, (Class I devices). Regardless of device classification or whether a notified body was involved, every manufacturer must fulfil both the essential requirements in accordance with Annex 1 and complete a Declaration of Conformity in accordance with Annex VII. Foreign manufacturers, without a registered place of business in the EU, must then apply for CE registration via an authorised representative in accordance with Article 14.2 of the Medical Device Directive (93/42/EEC). Following the recent publication of the in vitro diagnostic Directive (IVDD), authorised representative means: ‘any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to hte latter’s obligations under this Directive.’ (Directive 98/79/EC, Article 1, §2g). The registration is performed using the DIMDI (German Institute for Medical Documentation and Information) databank system. Unfortunately, this system can only be used to register either the manufacturers (providing they have a registered place of business in the EU) or their authorised representatives — but not both of them. Thus, in the case of non-European manufacturers, it is the authorised representatives who will receive confirmation of registration and not the manufacturers for whom they work.
Registration using the DIMDI databank system demands a familiarity with the Universal Medical Device Nomenclature System (UMDNS), which provides a common basis for device classification. Although UMDNS codes offer numerous advantages, as they reflect not only product categories but also subcategories, they unfortunately cause a lack of transparency. A manufacturer of a simple knee brace, for example, could register the device under UMDNS code 12-837, Orthoses, or UMDNS code 17-874, Orthoses, Knee, and should the manufacturer have a broad range of orthotic devices, it may have to use as many as nine different codes.
An additional hurdle is that registered trade names and trade marks lack authority and most devices are not reflected in the coding system in such a way as to alleviate the fears and uncertainties of distributors and end-users. Products that are broadly recognised in the United States, for example, will still receive scrutiny in the EU. Larger manufacturers are rarely asked to provide their European distributors or end-users with proof of CE compliance and they are seldom called upon to provide evidence of registration. On the other hand, small foreign manufacturers working via an authorised representative are requested to provide this evidence. This presents a predicament: how can they provide appropriate evidence of registration and compliance when they themselves are not reflected in the DIMDI databank system and do not receive a transparent confirmation of registration?
Unfortunately negotiating the DIMDI maze is not the only obstacle a small manufacturer must face. After successfully completing a suitable conformity assessment procedure in accordance with the relevant directives, the manufacturer must then gather the various directives, standards and guidance documents needed to demonstrate compliance. This proves to be a daunting task as the guidelines and official documents published by the European Commission are distributed by numerous institutions and organisations who also make a substantial charge.
A possible solution to these obstacles would be the creation of a central website, based on the website of the US Food and Drug Administration (FDA). Not particularly user-friendly the EU website lacks the open transparency that the FDA website provides.
Final compliance with the relevant directives does not mean that the finishing line has been crossed. Standards are revised constantly and those manufacturers who do not actively take part in these revisions — or have regulatory affairs officers to track them — will find it nearly impossible to keep up-to-date. Consequently, small manufacturers are often found to be non-compliant during re-auditing as the documents they are using have been superseded.
Regular meetings of notified bodies are held in order to exchange experiences and issue recommendations regarding grey areas that have come to light within the Directives. However, although these recommendations have little or no legal standing within the EU and are not published, they have a significant impact on the conformity assessment procedure. Mistakes regarding simple classification issues inevitably lead to non-compliance and will result in a complete change in such areas as labelling and packaging. For example, what is the exact definition for a Class 1 device with a measuring function? Are simple urine drainage bags with graduation marks Class 1 or Class 1 with measuring function? The same question applies to small plastic beakers and spoons for administering medicines. Moreover, these questions are still being discussed, even though the transition period has long since gone.
A large percentage of medical devices distributed within the EU are designed and manufactured by small overseas companies, but if the competent authorities fail to understand the unique needs of these manufacturers, there is a risk that an important source of medical supplies will be lost. The elimination of both physical and conceptual trade barriers was a founding principle of the EU, but the existence of a system that presents virtually insuperable barriers to for foreign manufacturers cannot be said to uphold that admirable goal.
By: Hans Haindl