Health Technology in Europe - Regulatory Framework and Industry Perspectives of the "New Approach"

Medical devices should provide patients, users, and third parties with a high level of protection and reach the performance levels attributed to them by the manufacturer. The maintenance or improvement of the level of protection, attained in the member states of the EU, is one of the essential objectives addressed by the medical device directives. The EU regulatory framework for medical devices according to the "new approach" is based on the responsibility of the manufacturer and balances free movement of products and protection of health. Broad "essential requirements" for devices are laid down in the medical device directives, as opposed to the detailed and prescriptive "old approach" directives, and European standardization organizations are mandated to prepare harmonized standards, with a presumption of conformity to relevant essential requirements, if devices comply with these harmonized standards. Industry has been a very strong supporter of the "new approach" regulatory system. The three medical device directives, by virtue of their broad essential requirements, supporting voluntary standards, and lack of a prescriptive approach, allow considerable flexibility in technical solutions and are considered to be "innovation-friendly," while maintaining a high level of patient safety. Industry has contributed hundreds of experts toward the production of several hundreds of harmonized standards. With the advent of a number of innovative enabling technologies such as nanotechnology, which has the potential for enormous application in the medical technology field, and the trend toward "convergence" of existing technologies to produce new generations of products, industry is very keen on maintaining the principles of the new approach in the future regulation of novel medical technology products incorporating innovative or hybrid technologies. Industry\´s view is that, unless innovation-friendly, adaptable, and flexible regulation is applied to such products, there will- - be a strong disincentive toward investment in the necessary research and development in Europe.