ISO 13485 following Brexit

News: May 11 2021

A quality management system (QMS) based on the ISO 13485 standard is an internationally accepted model a medical device organization can implement to help demonstrate compliance to many laws and regulations of the medical device industry. ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices under European Directives and Regulations and UKCA marking medical devices under the UK MDR 2002. ISO 13485:2016 remains a state-of-the-art document.

We understand that there is a concern around the validity of accredited management system certificates issued by UK based conformity assessment bodies following the UK's departure from the EU. BSI issues ISO 13485 certificates under the following accreditations - United Kingdom Accreditation Service (UKAS) in the UK or the Dutch Accreditation Council (Raad Voor Accreditatie) (RvA) in Netherlands.

ISO 13485 certificates issued under the UKAS accreditation do not need to be transferred to an EU-27 conformity assessment body. UKAS' membership of the International Accreditation Forum (IAF) will continue unaffected by Brexit.

UKAS will continue to be a member of the European co-operation for Accreditation (EA) and its Multilateral Agreements (MLAs) and will retain its membership until 31 January 2022 (a two-year grace period following the UK departure from the EU). During this transition period, UKAS is working with EA to analyze the Trade & Coordination Agreement between the EU and the UK and then revise the EA membership criteria with the aim that UKAS remains an EA member. Both parties are confident that a satisfactory resolution shall be reached during 2021. There are no technical grounds for UKAS management system accreditation not to continue to be accepted after Brexit. Additional guidance has been published by UKAS: https://www.ukas.com/eu-exit-status/

While BSI accepts applications for ISO 13485 under the RvA accreditation for clients who wish to use the Dutch location, there is no requirement to switch existing or future ISO 13485 certifications issued under UKAS to RvA. It is entirely legitimate to hold a UKAS or RvA accredited ISO 13485 certificate and maintain a CE certificate issued from an EU Notified Body in another country, and the same for the UK Approved Bodies.

If you had joint CE and ISO audits, then they will continue to be done jointly because BSI NL and BSI Assurance UK limited:

  • have aligned 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.

There is one known exception: for EU manufacturers selling into Taiwan, we want to clarify the impact of Taiwan's Technical Cooperation Programme (TCP).

  • We had provided TCP letters under TCP II for UKAS certificates by BSI UK until 31 December 2020.
  • BSI are in the process of being recognised to the Taiwan TCP III for RvA accredited ISO 13485 certificates.
  • Once BSI NL is designated to Taiwan TCP III, our policy will be to provide TCP III letters with RvA accredited ISO 13485 certificates.