EN ISO 13485:2016 - The harmonized standard is here

ISO 13485:2016, the Medical Device Quality Management System standard, 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. 

Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation. Manufacturers that hold CE certification with BSI to allow them to place devices on the market in Europe (but do not hold separate ISO 13485 certification) will be assessed to EN ISO 13485:2016 from 1 April 2019. Manufacturers holding only ISO 13485 certification with BSI are required to transition to ISO 13485:2016/EN ISO 13485:2016 by 28th February, 2019.

The harmonization of EN ISO 13485:2016 is another step towards compliance to the recently published Medical Devices and IVD Regulations, which will supersede the current Directives in three and five years, respectively. You can find out more about the standard's harmonization in our recent blog post.

BSI can now offer UKAS-accredited ISO 13485 certification to ISO 13485:2016 and to EN ISO 13485:2016. Talk to us to find out more. 

BSI achieves accreditation to certify organizations to new ISO 13485:2016 standard

BSI, the business standards company, has become the first certification body to achieve accreditation for the issue of quality management certificates against the requirements of ISO 13485:2016.

To gain accredited status, BSI’s processes were independently reviewed by the United Kingdom Accreditation Service (UKAS) and the Standards Council of Canada (SCC). SCC accredits organizations that certify the management systems of medical device manufacturers.  Under the Canadian Medical Devices Conformity Assessment System CMDCAS, only certification bodies accredited by SCC are eligible to certify medical device manufacturers’ management systems. 

BSI is now able to issue both UKAS and SCC accredited certificates to the latest edition of ISO 13485, the internationally recognized quality management systems standard for the medical device industry, to its clients.

Existing BSI Certification customers have until 28 February 2019 to transition from ISO 13485:2003 and the associated European Standard EN ISO 13485:2012; we recommend you start to plan your transition with urgency. You can find our useful tools and resources below.

Gary Slack, Senior VP, Global Healthcare Solutions, BSI said: “ISO 13485 is the world’s leading Medical Device standard, with over 27,000 certificates globally, therefore we’re very proud to achieve accreditation from UKAS. We have invested heavily in making sure that we provide our clients with the best service possible to transition early to the standard.”ISO 13485:2016 Transition Timeline

Medical Device Single Audit Program (MDSAP)

The MDSAP is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements.  Five of the RAs (Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW) have been running a three year MDSAP pilot, finishing December 2016. CMDCAS auditing organizations were eligible to apply for authorization under the MDSAP program during the pilot phase. BSI was the first auditing organization authorized during the Pilot Phase. The operational phase of this program is scheduled to begin in January 2017.

Health Canada has announced that as of 1 January 2019, they will terminate their current CMDCAS program and only accept MDSAP certificates. Manufacturers with products on the market in Canada cannot wait until 29 February 2019 to transition to the ISO 13485:2016 certificate. Failure to meet the 1 January 2019 date for transition to a MDSAP certificate may mean your products will not be licensed in Canada.

Schedule your MDSAP transition audits now.

BSI recommends that if you have not been contacted by your BSI Account Manager or BSI directly, please contact us to discuss your transition to MDSAP as soon as possible. For further information on this decision and how it impacts your ISO 13485 certification please visit the page: bsigroup.com/mdsap.