May, 2013

• • European Parliament released its initial commentary on the European Commission’s Impact Assessment for the proposed Regulations on medical devices and IVDs
  • European Parliament released its initial commentary of the European Commission proposed on clinical trials
  • The European Commission issued a Recommendation for Member States on a common framework for a unique device identification system of medical devices in the EU
  • The International Medical Device Regulators Forum issued a proposal for a common submission standard

April, 2013

• The EN ISO 13485:2012 standard was harmonized in late 2012, a change from the 2003 version of the standard.  The normative text of the standard is the same, but the informative annexes at the beginning of the 2012 version clarify the relationship between the standard and the medical devices Directives.  Manufacturers should examine the informative annexes and do a gap analysis to ensure they maintain compliance with the Directives and other regulatory requirements.
• Australia’s TGA released guidance on their recent reclassification of joint implants: http://www.tga.gov.au/industry/devices-reforms-joint-implants-kinds.htm
• Health Canada will require administrative regulatory activities to be submitted in electronic format only: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/admin_subs_notice_avis_admin_pres-eng.php
• European Parliament released its initial commentary on the European Commission’s Impact Assessment for the proposed Regulations on medical devices and IVDs: http://www.europarl.europa.eu/committees/en/envi/studiesdownload.html?languageDocument=EN&file=85330
• European Parliament released its initial commentary of the European Commission proposed on clinical trials: http://www.europarl.europa.eu/committees/en/envi/studiesdownload.html?languageDocument=EN&file=91350

March, 2013

• European Parliament released its initial commentary on the European Commission’s Impact Assessment for the proposed Regulations on medical devices and IVDs: http://www.europarl.europa.eu/committees/en/envi/studiesdownload.html?languageDocument=EN&file=85330
• European Parliament released its initial commentary of the European Commission proposed on clinical trials: http://www.europarl.europa.eu/committees/en/envi/studiesdownload.html?languageDocument=EN&file=91350

February, 2013

• List of Harmonized Standards updated for Medical Devices, Active Implantable Medical Devices, and In Vitro Diagnostic Medical Devices.
• MEDDEV 2.12-1 Rev. 8 Released – Guidelines on a Medical Devices Vigilance System.
• More helpful documents for manufacturers on vigilance, including forms to use.
• Don’t Forget – the EU Regulation on e-IFUs comes into effect March 1

October, 2012