Monthly news from the German Medical Technology Association: BVMed, Reinhardtstraße 29b, D-10117 Editor: Manfred Beeres, Phone: +49 (0) 30 - 24 62 55 - 20, E-Mail: [email protected], www.bvmed.de

11/12 November 2012 Circulation: 2,800

SHI Finances : Chancellor Merkel 5 Points About New Medical Devices Regulation Is Reevaluating Berlin. In view of the record fi nancial Berlin. The European Commission submitted its pro- ase patient safety nor accelerate market access. For reserves accumulated by the health- posal for a new EU Medical Devices Directive. The the same reasons we oppose the „scrutiny process“. care system, German chancellor Angela commission is basically adhering to the „New Ap- 3. Improvements can be achieved in notifying and Merkel (CDU) is reconsidering her posi- proach“ that strengthens industrial responsibility. monitoring the notifi ed bodies in order to attain a tion regarding the quarterly practice fee. BVMed published fi ve points on the new regulation: uniform high quality in Europe. The chancellor was currently looking at 1. The „New Approach“ and the existing risk classes 4. There is no defi cit in regulations for medical de- the overall picture of the healthcare sec- should be retained, which means that the current vices, rather a defi cit in enforcing existing regulati- tor and “giving the arguments brought statutory regulations are suffi cient for manufac- ons. Therefore it makes sense to improve controls of forward a close look", said her spokes- turing and market-access of safe and high-perfor- manufacturers and the market. man, Steff en Seibert. In addition, due to mance medical devices. 5. Improvements in the traceability of medical de- the obvious fi nancial surplus, statutory 2. The current system of certifi cation through nati- vices should be introduced through the consistent health insurances are increasingly get- onally accredited and monitored testing authorities implementation of „Unique Device Identifi cation Sy- ting under pressure by politicians to pay shall in principle remain in place. We reject manda- stems“ (UDI) for all medical devices. back premiums to their insured. tory offi cial approval, since it would neither incre- More at www.bvmed.de (press releases).

Medtech Needs Interdisciplinary German Quality Campaign for Endoprosthetics Cooperation Berlin. The medtech innovation con- Berlin. The starting signal for the EndoCert project systematically optimizes major aspects of the re- ference „Fortschritt erLeben“ in Berlin by the German Association of Orthopedics and Or- spective structural, procedural and quality outco- called for interdisciplinary collaboration thopedic Surgery (DGOOC) at the end of October mes in German hospitals. Participation in the en- between researchers, physicians, and the means that, in addition to the German Endopros- doprostheses register is the basic prerequisite for medtech industry as a basic prerequisite theses Register (EPRD), another major sub-project the certifi cation process of a hospital“, says FBEI for real progress in medical technology. of the quality campaign for hip and knee endopros- spokesman Marc Michel. With EndoCert, hospitals Various experts diff ered about the ideal theses is now up and running. The member com- performing replacement arthroplasty are for the timing of getting health insurance funds panies of the BVMed orthopedic implant working fi rst time able to be certifi ed as has been common involved in the innovation process. group (FBEI) are positive about the EndoCert project. practice for industry companies for many years. “The EndoCert certifi cation system analyzes and More at: www.medinsight.de.

Health Pool Surplus Berlin. The fi nancial situation of the Ger- man healthcare system will continue to MedInsight : improve. At the end of the year, the sur- plus of the health pool will amount to Latest News on Europe’s Biggest Market! 12.7 billion euros – an increase of 3.2 bil- lion euros, the working group on Statu- tory Health Insurance (SHI) funding an- nounced.

New State Premier Mainz. (51), the most se- nior Minister of Health in Germany, will become the new State Premier in Rhine- land-. She succeeds , who has headed the federal state for 19 years. 51-year-old lawyer Ms. Dreyer has been Minister of Health and Social Aff airs in Rhineland-Palatinate for over ten years. MedInform has published a new issue of MedIn- care Pool Surplus; German Industry Establishes sight Germany, a background report authored by Healthcare Industry Committee; Number of Cardiac Medtech @ Social Media the German medtech experts Joachim M. Schmitt Deaths in Germany Decreasing Further; ICD-10-GM RSS: www.bvmed.de/rss-feeds and Manfred Beeres together with AdvaMed. 2013: DIMDI Publishes Final Version. Twitter: www.twitter.com/bvmed MedInsight gives the latest news on Europe’s big- Facebook: www.facebook.com/bvmed gest medtech market. AdvaMed, Eucomed and BVMed member compa- Youtube channel: www.youtube.com/ nies can receive "MedInsight Germany" at a dis- medizintechnologien Topics from the new issue are e. g.: SHI Fi- counted subscription price of 600 euros per year nances: Chancellor Merkel Is Reevaluating; Five (10 issues). The normal subscription fee is 1,200 Points About New Medical Devices Regulation; euros for one year. You can order a free trial copy of Medtech Needs Interdisciplinary Cooperation; MedInsight at: [email protected]. Documentation: JFC on Medical Devices; Health- More at: www.medinsight.de