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.