Browse through the list of 2011 MD Enews Archive

2012 Enews archive

2012 Enews

29 March 2012

Medical Device Vigilance and Guidance Revisions >

The guidance on Post Market Clinical Follow-Up (PMCF) studies (MEDDEV 2.12-2 rev.2) provides much improved guidance to manufacturers and Notified Bodies in replacing MEDDEV 2.12-2 Clinical Evaluation - Post Market Clinical Follow-Up dated May 2004 and implementing section 1.1.c of Annex X of the Medical Device Directive (MDD).

13 August 2012

BSI announces specialized regulatory training courses for the healthcare industry >

BSI Group America Inc., a leading provider of total solutions for certification and standards announces the launch of Specialized Regulatory Training courses targeted specifically for the medical device industry.

17 February 2012

EU Commission Issues Statement on Medical Device Regulations following PIP Breast Implant Problem >

The European Health and Consumer Policy Commissioner, John Dalli, called on EU Member States for immediate action to be taken on a national level to ensure full and stringent implementation of the current legislation on medical devices

22 February 2012

EU Publishes EN ISO 13485:2012 >

The European standard, EN ISO 13485:2012 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes, has been published, after approval by CEN on January 24, 2012.

26 September 2012