ABSTRACT

Standards provide for the growth of markets. Across a market as a whole, standardisation offers efficiencies in terms of maintenance, compatibility and elimination of wasteful duplication or unproductive labour (DTI 2005). Standards also underpin the regulation of products. For example, in the European Union, the “placing onto market” of medical devices is governed by a number of European Council directives that are implemented though national law. The directives specify essential regulatory requirements, corresponding to the quality, safety and performance of medical devices. Modular, open, voluntary and harmonised standards support compliance with the regulatory requirements. Within the EU, this exemplifies a class of “new approach” directive. Contrasting “old approach” directives contain a large amount of technical detail, which adds to the challenge associated with approval and revision. For new approach directives, bodies such as CEN and CENELEC prepare consensus standards to support compliance. National Standards Bodies (NSB) are involved in the generation of consensus standards and private, independent, certification authorities or “Notified Bodies” assess conformity. This means that new approach directives need only contain essential requirements. For medical devices, the adoption of harmonised consensus standards provides benefit as a single European standard replaces numerous national standards. Harmonised standards therefore cut the cost of compliance, provide a single point of access to the market and support free trade. As the adoption of standards is voluntary, organisations are free to innovate, although in many cases, incorporation of tried and tested solutions is appropriate. In these cases, product standards provide a basis for quality, consistency, comparability and testing. For consumers, standards communicate

an attribution of quality and safety that would otherwise remain hidden (e.g. use of the CE mark).