Latest NEWS updated 31 January 2012 The European Commission has written a new MEDDEV 2.1/6: Guideline on the Qualification and Classification of stand alone software used in Healthcare within the Regulatory Framework of Medical Devices. It addresses both Medical and IN-Vitro Diagnostic medical devices. The document can be found Here. A new MEDDEV document 2.12/2rev.2 has beeb published covering Post Market Clinical Follow-up. This document is intended to be a guide for manufacturers and notified bodies on how to carry out Post-Market Clinical Follow-up (PMCF) studies in order to fulfill Post-Market Surveillance (PMS) obligations. This MEDDEV document can be found here. Austria is introducing a new tax system on medical devices which must be paid for the first time by June 2012 for the year 2011. This tax payment is used by the Austrian Competent Authority (Austrian Federal Office for Safety in Health Care) to monitor the medical devices market and carry out its national vigilance (read: enforcement) responsibilities. It will be a single annual fee which must be paid by any person or organization who delivers a medical device to a final consumer (or end user) in return for payment. This includes renting or leasing of medical devices. The tax rate is based on risk classification as follows in Euros: Risk Class 1 medical devices, €250 (Approx. US$355) Risk Class IIa medical devices and self-testing IVDs, €300 (Approx. US$413) Risk Class IIb medical devices and IVDs in Annex II list B, €350 (Approx. US$482) Risk Class III medical devices, IVD;s in Annex II list A: Active implantable medical devices, €400 (Approx. US$550). Companies supplying multiple risk classification of devices will only need to pay the highest tax and not a total of all the taxes together. Larger companies with several establishments will only have to pay a maximum of €2,000 (Approx. US$2,753) in total. Contact QNET