Analysis of the regulatory hurdles in European Diagnostics

In a move aimed at harmonising diagnostics regulations, the European parliament amended the medical devices directive (MDD) of 1993 to bring in the IVD directive (98/79/EC) in 1998.

The directive is made up of a number of articles that outline definitions, standards and vigilance and as from December 7, 2003, has been enforced in the 25 European Union (EU) member states and the four European free trade association (EFTA) members namely, Iceland, Norway, Liechtenstein and Switzerland. While many regulatory hurdles have been removed with the implementation of the Conformite Europeene (CE) mark, this multinational standardised mark further allows global manufacturers to distribute their products within the EU, eliminating the need for additional quality testing or approvals.

However, while the CE mark indicates that the product meets the relevant IVD directives, critical language compliance issues have arisen, increasing the costs for manufacturers. The requirement for translating usage instructions into local languages has been transposed into 15 EU countries’ national laws, as these countries do not differentiate between lay products and those used by professionals. As a result, IVD companies have had to increase their translation activities from 5 to 15 European languages since 2000.Hence, depending on the market size, companies will now have to decide if it is beneficial to translate their products' instructions for use in order to continue serving a market in the future.

“This will affect smaller markets, and the health systems of small countries are likely to suffer as a consequence,” notes Frost & Sullivan Research Analyst Dr. Fiona Rahman. “Since Europe is now an in an open market era, customers may be forced to buy IVDs from other neighbouring countries, but at their own risk and outside the liability of the manufacturer.”

Also posing challenges are the substantial differences in the U.S. and European labelling requirements While the IVD directive encourages that the information on labels are presented as harmonised symbols, these symbols do not need to be accompanied by text explanations as per the U.S. food and drug administration (FDA) requirements. Although few would disagree that symbols on labelling are beneficial, the reluctance of the FDA to accept their use is a barrier to their universal adoption. The primary concern of the FDA is the possibility of end users not being able to understand the symbols, which might result in an unsafe use of the product.

Overall, the IVD directive has presented market participants with a combine of advantages and disadvantages. The disadvantages of regulations are that they increase the cost of the products and delay their introduction in the commercial market. In addition, along with the implementation of regulations comes more administrative works such as paperwork, registration and approvals.

Nevertheless, overbearing these disadvantages, companies complying with these regulations will gain better access to more geographic markets, and thus see an increase in the production and market value of their compliant products. Also, harmonised regulations encourage the development of new technology and since only quality products are allowed to enter the market, there is bound to be an increased value for the eventual end users.

“While the market believes that the IVD directive has increased the level of regulation for IVD products in Europe, when applied together with the common technical specifications (CTS), will increase the uniformity and quality of higher-risk products,” says Dr. Rahman. “By incorporating translation and labelling changes, manufacturers can cost-effectively market their products worldwide and hence what may now appear as a chaos of regulatory requirements could pave way for a successful international product release.”