Here at BSI, we are focused on solving our clients' biggest challenges by providing new methods and technology that promote deeper trust, sustainability and security. To stay at the forefront of excellence and innovation, we will start applying a piece of electronic data known as a ‘digital seal’ to our MDR/IVDR and UKCA certificates from November 2024.
• This innovation enhances the security of the MDR/IVDR and UKCA certificates we issue you.
• Certificates with digital seals cannot be edited or copied, and the validity of the seal can be verified hence reducing the instances of falsification/tampering.
• This may bring additional benefits to you in faster registration of your products by negating the need for notarising the certificates (in certain jurisdictions) and help your sustainability goals by eliminating the need for shipping associated with the notarisation of certificates.
You will not incur any additional costs for having a certificate issued with a digital seal and you don’t need to do anything or need special software. We will apply the digital seal when we issue the certificate and once applied, the digital seal will be valid for the duration of the validity of the certificate.
Any MDR/IVDR/UKCA certificates without a digital seal (i.e. those already issued or those that will be issued prior to November 2024) will continue to remain valid. Digital seals will be applied to those certificates when they are next re-issued or renewed (whichever comes first).
Please note that at this stage, digital seals are only being applied to MDR/IVDR and UKCA certificates and not to other certificate types such as ISO 13485 or MDSAP.
Where can I find additional information?
Please refer to our Digital Seal dedicated Q&A brochure for additional information on digital seals and how they enhance the security of certificates issued to you.
Our priority remains to maintain patient safety and ensure compliant conformity assessments for all products within the new regulatory framework.
Sincerely,
Jayanth Katta
Regulatory Director and Head of Medical Devices Notified Body Regulatory Services BSI
