Planned EU regulation: Are additional rules overwhelming the medical technology sector? -- COMPAMED Trade Fair

Planned EU regulation: Are additional rules overwhelming the medical technology sector?

The European medical device directive is currently at a turning point. It was initiated by the 2011 breast implant scandal. A French corporation had sold implants with cheap industrial silicone for years and even deceived inspection points. This incident newly aroused the debate over safety and transparency of the European medical device regulation.

02/02/2015

Photo: Glasses lying on a thick book

The current draft law for the proposed EU regulation contains about 200 pages. For many companies, this flood of additional rules probably means the retirement of the market; © panthermedia.net/Harald Richter

Photo: Lots of sticky labels cause confusion

Until a medical product gets on the market there are a number of hurdles. Unfortunately approval procedures already cause confusion at the national level and regulations are anything but standarized at international level; © panthermedia.net/iqoncept

Photo: Hand ticking of a check list

With the extent of the EU directive quality management tends to become a mere formality. Test criteria could simply be checked off without critical analysis of the actual objective; © panthermedia.net/Gunnar Pippel

Photo: Melanie Günther; Copyright: B. Frommann

© B. Frommann