A quality management system (QMS) based on the ISO 13485 standard is an internationally recognised model that a medical device organisation can implement to help demonstrate compliance with the many laws and regulations of the medical device industry. ISO 13485 is the QMS standard recognised as the basis for CE marking of medical devices under European Directives and Regulations and UKCA marking of medical devices under UK MDR 2002. ISO 13485:2016 continues to be a state-of-the-art document.
We understand that following the UK’s departure from the EU there is a concern about the validity of accredited management system certificates issued by UK-based conformity assessment bodies, such as the United Kingdom Accreditation Service (UKAS) in the UK or the Dutch Accreditation Council (Raad Voor Accreditatie) (RvA) in the Netherlands.
ISO 13485 certificates issued under 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 remain a member of the European Accreditation Cooperation (EA) and Multilateral Agreements (MLA) and will retain its membership until 31 January 2022 (a two-year grace period following the UK’s departure from the EU). During this transitional period, UKAS is working with the EA to analyse the Trade and Coordination Agreement between the EU and the UK and subsequently revise the EA membership criteria with a view to UKAS remaining an EA member. Both parties are confident that a satisfactory solution will be reached in 2021. There is no technical reason why UKAS management system accreditation should not continue to be recognised after Brexit. Additional guidance has been issued by UKAS: https://www.ukas.com/eu-exit-status/
Whilst we accept ISO 13485 applications under RvA accreditation for customers wishing to use the Dutch location, there is no obligation to pass existing or future ISO 13485 certificates issued under UKAS to RvA. It is perfectly legitimate to hold a UKAS or RvA accredited ISO 13485 certificate and retain a CE certificate issued from an EU Notified Body in another country and the same applies to UK Notified Bodies.
If you have joint CE and ISO audits, they will continue to be done jointly as it limits
Having processes in line with existing ISO 13485 Assessment Certification Schemes (under UKAS and SCC Accreditation) e.g. same assessors, same competencies and support processes UKAS and RVA ISO 13485 have the same processes/scheme guidance/procedures.
There is one known exception: For EU manufacturers selling to Taiwan, it is necessary to clarify the impact of Taiwan’s Technical Cooperation Programme (TCP).
Until 31 December 2020, TCP approval under TCP II is required for UKAS certificates.
For RvA-approved ISO 13485 certificates, Taiwan is in the process of being recognised under TCP III.
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