As the updated list of references of harmonized standards published in November 2017 indicates, the Medical Device Quality Management System standard ISO 13485:2016 has been harmonized to the European Medical Devices Directives MDD, AIMDD and IVDD. EN ISO 13485:2016 now replaces the previous version of the standard, EN ISO 13485:2012, in the EU Official Journal, with the date of ‘cessation of presumption of conformity’ of EN ISO 13485:2012 stated as 31 March 2019. From this date on, the superseded standard ceases to give presumption of conformity with the essential requirements of the Medical Device Directives.
Manufacturers that hold EC Quality Assurance certification to allow them to place devices on the market in Europe but that do not hold separate ISO 13485 certificate will be assessed to EN ISO 13485:2016 from 1 April 2019. The certification body may have defined a different transition deadline for manufacturers holding ISO 13485 certificates – but it can only be earlier than the date of cessation. Thus, there is a maximum of one year ‘to go live’.
Are you still at the starting line? Conducting a gap analysis against your current system might be a reasonable way to start the project. Are you aware of the gaps but have no time to update your documentation? An extra pair of hands might solve this problem. No matter whether you need expertise in finding the gaps or labour to fill them in, Medfiles’ team is ready to help you!