Revision 7 of MEDDEV 2.12-1, the new European Medical Device Vigilance Guidelines, will replace the current version on June 15, 2012. It may lead you to update your vigilance and post-marketing procedures.
Most recent articles
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What The Newest Revision Of The EU Vigilance Guidelines
20 June 2012, by Rene Clement -
New MEDDEV Guidelines on Postmarket Clinical Follow-Up Studies
20 April 2012, by Rene ClementIn addition to MEDDEV 2.7.1 rev.3, “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies,” that was published in December 2009, a new document (MEDDEV 2.12-2 rev.2) has been published, which describes the sources of data/documentation used in clinical evaluations and the appraisal and analysis of clinical data for CE-marked commercial medical devices.
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2012 French Tax on Medical Devices:
26 February 2012, by Rene ClementThe 2012 law on financing French social security (the Social Security Financing Bill), which was officially published on December 22, 2011 and wanted to reduce the national budget deficit, includes a full revision of the AFSSAPS tax. According to the provisions of the new law, the annual tax is now being levied to help finance social security, instead of AFSSAPS, and shall be paid by the companies that are subject to the value added tax (VAT) and make the first sales in France. The first (…)
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Medical Devices: Full Manufacturer and EAR addresses on MD labels?
15 February 2012, by Rene ClementA decision, taken by CMC, intended to achieve a common interpretation of the requirement that a manufacturer has in relation to the provision of its address on the label and the instructions for use (IFU)
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Medical Devices: Latest News Regarding Electronic Instructions for Use
28 December 2011, by Rene ClementEU Regulatory Committee on Medical Devices approves regulation on e-instructions for use of medical devices
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FAQ
22 August 2011, by Rene Clement -
Our Contracts
22 August 2011, by Rene ClementService Proposals and model of contract for Medical Devices Service Proposals and model of contract for In Vitro Diagnostic Medical Devices Questionnaire for receiving a proposal estimate
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NEW REGISTRATION REQUIREMENTS FOR MEDICAL DEVICES IN POLAND
18 June 2011, by Rene ClementThe new Polish Act of 20 May 2010 on medical devices published on the 18th September 2010 (Official Journal of Law No. 107, item 679) will fully enter into force in May 2011 with the application of the last provisions regarding the European Databank EUDAMED.
Let’s have a look on the main changes regarding registration/notification of medical devices in Poland. -
CLINICAL INVESTIGATIONS: European Commission Publishes two New MEDDEV Guidelines
15 March 2011, by Rene ClementChanges introduced by Directive 2007/47/EC amending Council Directive 90/385/EEC and Council Directive 93/42/EEC conducted the European Commission to publish revised or new MEDDEV Guidelines. The last ones dated December 2010 but available in January 2011 concern Clinical investigations.
Let’s have a look at these new documents. -
THE CERTIFICATE OF FREE SALE FOR CE-MARKED MEDICAL DEVICES
15 January 2011, by Rene ClementQA/RA Directors of US manufacturers of Medical Devices may receive a request from their International sales department for Certificates of Free Sale (CFS). They are effectively mandatory for the registration of CE marked devices which are not yet FDA approved in the main countries of Latin America, Asia and non-EU Eastern Europe.
In addition the CFS may need to be apostilled or legalized depending upon the concerned area. Where and how to obtain these CFS? MediMark® Europe, European (…)