Tag: MEDDEV 2.12/1

New MEDDEV 2.12-1 Revision 8 released for Guidelines on a Medical Devices Vigilance System

MEDDEV 2.12-1, “Guidelines on a Medical Devices Vigilance System,” has just been revised with the release of Revision 8 and it’s available now from Document Center Inc.  We’ve discussed this particular Guideline in general in a previous blog.

All MEDDEV guidelines are regularly updated accordingly with regulatory developments.  For this reason, the latest version of the guidelines should always be used.

This 2013 revision of MEDDEV 2.12-1 has:

  • carefully considered and transposed into the European context the Global Harmonisation Task Force (GHTF) international regulatory guidance documents on vigilance and postmarket surveillance,
  • addressed the introduction of European medical device database EUDAMED and
  • amended the document in light of experience with previous clauses.

Additionally, MEDDEV 2.12-1 Revision 8 explicitly includes IVF/ART devices within the scope of the vigilance system and provides clarity in relation to devices that are not intended to act directly on the individual. This newly revised 64-page guidance document will be applicable as of July 2013.

If you’re in the Medical Device industry and want to keep up with the latest releases of both standards and regulatory documents, you’ll want to use Document Center’s website, www.document-center.com, on a regular basis.  We provide information on Standards for the Medical Device Industry as well as information on Regulations and Harmonized Standards.  Feel free to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) if we can personally help you in any way.  We are dedicated to improving the way companies like yours procure and use compliance information.

Document Center’s 20 Top Selling Standards of 2012

Yes, it’s time to review Document Center‘s top selling standards of 2012.  Do you use any of these popular items?

  1. BS EN ISO 13485, New 2012 Edition, Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes
  2. BS EN ISO 14971, New 2012 Edition, Medical Devices. Application of Risk Management To Medical Devices
  3. ISO 15223-1, New 2nd Edition, Medical Devices – Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied – Part 1: General Requirements
  4. BS EN ISO 15223-1 (paper or CD Rom format), New 2012 Edition (replaces BS EN 980), Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied. General Requirements
  5. ASTM F2096, 2011 Edition, Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
  6. AMS 2750, New Revision E, Pyrometry
  7. 21 CFR Parts 800-1299, 2012 Edition, Code of Federal Regulations – Title 21–Food and Drugs (Parts 800 To 1299)
  8. ISO 19011, 2011 Edition, Guidelines for Auditing Management Systems
  9. SOR/98-282, 2012 Consolidated Edition, Medical Devices Regulations (Canada)
  10. IEC 60601-1, Consolidated Edition 3.1 with Corrigendum, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
  11. MEDDEV 2.12/1, New 8th Revision, Guidelines on a Medical Devices Vigilance System
  12. ASTM E1417, 2011 Edition with Editorial Change, Standard Practice for Liquid Penetrant Testing
  13. ASTM E18, 2011 Edition, Standard Test Methods for Rockwell Hardness of Metallic Materials
  14. ASTM A370, 2012A Edition, Standard Test Methods and Definitions for Mechanical Testing of Steel Products
  15. IPC-A-610, Revision E, Acceptability of Electronic Assemblies
  16. ISO 11137-2, 2012 Edition, Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose
  17. ASTM A240/A240M, 2012A Edition, Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
  18. ASQ Z1.4, 2008 Edition, Sampling Procedures and Tables for Inspection by Attributes
  19. ISTA 2A, 2012 Edition, Performance Tests for Packaged-Products, Packaged-Products 150 Lb (68 Kg) or Less
  20. IPC/WHMA-A-620, Revision B, Requirements and Acceptance for Cable and Wire Harness Assemblies  — tied with the all time favorite: ISO-9000, 2005 Edition, Quality Management Systems – Fundamentals and Vocabulary

All these standards are available from Document Center Inc. at our webstore, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to assist you with both your standards purchases and the services you need to maintain your standards collection.

New MEDDEV 2.12-1 Revision 7 on Guidelines on a Medical Devices Vigilance System

The new MEDDEV 2.12/1 Revision 7 has just been released.  Titled “Guidelines on a Medical Devices Vigilance System,” the new document is available from Document Center Inc.  now.  The principal purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients.  This is to be achieved by evaluating reported incidents and, where appropriate, disseminating information which could be used to prevent any repetitions, or to alleviate the consequences of such events.

The guideline is intended to facilitate the uniform application and implementation of the Medical Device Vigilance System requirements contained in three European Directives:

  • the Directive for Active Implantable Medical Devices (AIMD), 90/385/EEC
  • the Directive for Medical Devices (MDD), 93/42/EEC
  • and the In Vitro Diagnostic Medical Devices Directive (IVDD), 98/79/EC.

Revision 7 of MEDDEV 2.12-1 incorporates two new Report Forms (Annex 6-Manufacturer’s Periodic Summary Report and Annex 7- Manufacturer’s Trend Report Form) and updates two existing Report Forms (Annex 3 and Annex 4).  Field Safety Corrective Action (FSCA), Field Safety Notice (FSN), Use Error and Abnormal Use are new concepts introduced in this revision of the guideline.   The revised guidance will be applicable as of June 15th, 2012.

Corrective action includes   a device recall, the issue of a Field Safety Notice, additional surveillance/modification of devices in use, modification of future device design and/or components and/or the manufacturing process, and modification to labeling and/or instructions for use.

The MEDDEV guidelines in general are a set of documents relating to questions of application of EC-Directives on medical devices. They are not legally binding. The guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, and so on).

They are available from Document Center Inc. at our website, www.document-center.com.  Or you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Because we have a large number of medical device manufacturers as customers, we particularly catalog and monitor a number of medical device documents that cannot be found at other standards vendors.