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

March 2017 03/17 Circulation: 2,200

German Electoral Campaign: Compliance: BVMed Publishes Model Contracts SPD Party to Focus on Health Berlin. The SPD chancellor candidate Berlin. The Association of German Hospital Di- mustervertraege. and new party leader, , rectors, VKD, and BVMed have updated and pub- “A close cooperation between manufacturers intends to put a strong focus on the lished their joint “Model contracts on selected and medical institutions is necessary and politi- topic of justice and equity in his elec- forms of cooperation between medical device cally desired for progress in medical technology toral campaign. This includes the So- manufacturers and medical institutions and their and for the safe application of medical devices. cial Democrats’ plan to reorganize the employees.” The 24-page brochure contains a de- However, such cooperation is increasingly run- funding of the healthcare system. A tailed description of principles of cooperation, as ning into risks of criminal liability. The utmost parity-based citizens’ insurance and well as numerous model contract provisions for goal is therefore to avoid any suspicion of corrup- the harmonization of doctors’ fees are agreements covering various forms of coopera- tion. The principles of the ethical code on med- part of their agenda. Martin Schulz tion between hospitals and the industry. ical devices commerce and the updated model served as President of the European The updated model contracts, first formulated contracts help to achieve this goal,” according to Parliament until the end of 2016. In with the VKD association in 2006, can be down- BVMed CEO Joachim M. Schmitt. the polls at the beginning of February loaded in German language at www.bvmed.de/ Read more at www.medinsight.de. 2017, Schulz’ rating was already level with that of Chancellor . Medical Device Regulation: Seven Major Changes

Brigitte Zypries New Federal Berlin. Almost five years after the announce- IIb devices for the application or removal of med- Minister for Economic Affairs ment of the two Commission proposals for the ical drugs; 2. New regulation of market surveil- Berlin. Former Federal Minister of Jus- European Medical Device Regulation, MDR, and lance with shorter reporting deadlines; 3. Addi- tice is the new German the European In Vitro Diagnostic Medical Device tional reports and plans (PMS, PMCF, PSUR, SSCP); Minister for Economic Affairs. The SPD Regulation, IVDR, they are due to be adopted. 4. Significantly stricter requirements for the prep- politician succeeded in The regulations will come into force in summer aration of clinical data; 5. Staged introduction of January 2017, who in turn succeeded 2017 and their application will become manda- UDI codes; 6. Higher classification of certain sub- Frank-Walter Steinmeier as Foreign tory three years later. stances and surgically invasive medical devices; Minister. The seven major changes brought about by the 7. Extension of the application area to include in- MDR are as follows: 1. Introduction of the so-called struments for cosmetic surgery. scrutiny procedure for class III implants and class Read more at www.medinsight.de. Health Minister Groehe Outlines “Digital Health Agenda” Frankfurt. Federal Minister of Health Hermann Groehe believes that a “dig- MedInsight : ital health agenda” will contribute to a reasonable use of the opportu- Latest News on Europe’s Biggest Market! nities provided by digitization. In a guest commentary for the daily news- paper “Frankfurter Allgemeine Zei- tung”, Groehe emphasized that the only way to use the digitization of the healthcare system for real progress was to place human needs and not the technological possibilities in the fo- cus. In his guest commentary, Minister Groehe especially points at new diag- nostic options resulting from the anal- ysis of large data volumes. To this end, a risk-based, uniform European ap- proach to data protection is required.

MedInform has published a new issue of tracts; German Health Minister Groehe Out- Cardiovascular Diseases and Cancer MedInsight Germany, a background report lines “Digital Health Agenda”; German Med- Most Common Causes of Death authored by the German medtech experts ical Association Against Citizens' Health Wiesbaden. Most people in Germany Joachim M. Schmitt and Manfred Beeres in Insurance; 2016 Heart Report Presented; still die from cardiovascular diseases. cooperation with AdvaMed. MedInsight gives Cardiovascular Diseases and Cancer Most In 2015, more than 356,000, or 39 per- the latest news on Europe’s biggest medtech Common Causes of Death. cent, of all deaths were caused by car- market. diovascular diseases, the Federal Sta- AdvaMed, Eucomed and BVMed member tistical Office reported. Topics of the new issue are e. g.: Medical companies receive "MedInsight Germany" at a Device Regulation (MDR): Seven Major discounted subscription price of € 600 per year Changes; German Electoral Campaign: (10 issues). The normal subscription fee is € 1,200 Follow us on Twitter: SPD Party to Focus on Health; Healthcare for one year. You can order a free trial copy of www.twitter.com/bvmed Compliance: BVMed Publishes Model Con- MedInsight at: www.medinsight.de