Information for CBMS on transition to certification according to SRPS EN ISO 13485:2017 and on IAF mandatory document IAF MD 9:2017

We hereby inform all interested parties that on 30 November, 2017 the Institute for Standardization of Serbia published the standard SRPS EN ISO 13485: 2017 Medical devices - Quality management systems - Requirements for regulatory purposes. The Accreditation Body of Serbia (ATS) hereby informs accredited certification bodies (CBs) for certification of management system for medical devices that the transition period for transition to certification according to the new standard is three years from the publication of the ISO standard, which means until 31 March, 2019.

It is necessary that the accredited CBs for certification of management systems provide  ATS with The Plan of transition to certification according to SRPS EN ISO 13485: 2017 with an assessment of the impact of transition to the management system by 30 April, at the latest, and in accordance with the plan, all the management system documents that have been amended due to new and changed requirements of the SRPS EN ISO 13485: 2017 and the mandatory document  IAF MD 9: 2017 (date of implementation 9 June2018) with a clear identification of the changes in order to for ATS to check, in accordance with the Rules of Accreditation and plans, the application of the requirements of new standard at the headquarters of the certification body and minimum one on-site witnessing at the client's site, during regular surveillance assessment or re-assessment.

ATS will not accept applications for accreditation of certification bodies for certification of management systems for medical devices according to the standard SRPS EN ISO 13485: 2014 after 20 April 2018, ie the beginning of the receipt of applications for accreditation of CBs that certify management systems for medical devices according to the new edition of the SRPS standard EN ISO 13485: 2017 is April 20, 2018.

Assessments for CBs that certify management system according to the new edition of the standard SRPS EN ISO 13485: 2017 (including the requirements for CBs laid out in IAF MD 9: 2017) will begin on 1 May, 2018, and the assessment will solely be for CBs that certify management systems for medical devices according to the new edition of the standard as of 1 September 2018, whereas for IAF MD 9: 2017 they will start as of 9 June, 2018. The deadline for completing the assessment for the purpose of moving to the accreditation of the management system for medical devices according to the new edition of the standard is 1 January, 2019. In accordance with resolution IAF Resolution 2015-13, the end of the transition period is 31 March, 2019, or 9 June, 2018 for IAF MD 9: 2017 (EA Resolution 2017 (40) 25).

We hereby also inform you that the accreditation for certification of management systems according to SRPS EN ISO 13485: 2014 will remain valid for each CB until either the transition is completed or until the expiration of the deadline for transition. Accreditation for certification of management systems for medical devices will be withdrawn to any CB that does not achieve a successful transition before the expiration of the deadline for transition.