Current BSI ISO 13485 certificates do not need to be transferred to an EU-27 conformity assessment body; they are issued by BSI which is accredited by the accreditation body United Kingdom Accreditation Service (UKAS) or Standards Council of Canada (SCC). We understand that there is a concern around the UKAS accredited management system certificates in the event of a no-deal Brexit.
UKAS’ membership of the International Accreditation Forum (IAF) will continue unaffected by Brexit. UKAS has made assurances that it will not cease to be a member of European co-operation for Accreditation (EA) and its Multilateral Agreements (MLAs) after 29 March 2019 and indeed will be able to retain its membership until at least December 2020. After this date the EA has also agreed to a further two-year grace period to consider changes to the membership criteria to ensure that UKAS can continue as a member body in the future. There are no technical grounds for UKAS management system accreditation not to continue to be accepted after Brexit.
The UKAS Brexit guidance:
Whilst BSI will be taking applications for ISO 13485 under the RvA accreditation for those clients who wish to use the Dutch location; there is no requirement to switch existing or future ISO 13485 certifications to RVA. It is completely legitimate to hold a UKAS or SCC accredited ISO 13485 certificate and maintain a CE certificate issued from a Notified Body in another country. Therefore, BSI will not effect any planned migration of ISO13485 certificates with other accreditations.
If you had joint CE and ISO audits, then they will continue to be done jointly because BSI NL and BSI Assurance UK limited:
- Are aligning processes to the existing ISO 13485 Assessment Certification Schemes (under UKAS and SCC Accreditation), e.g. the same assessors, same competencies and support processes
- UKAS and RVA ISO 13485 have identical processes/scheme manual/procedures.
Where can I find more information?
Please check our Brexit web page for the latest information available and ongoing updates. If you have any questions or concerns, please contact your normal BSI contact at any time.