Transfer to BSI
At BSI, we understand that having confidence in your Notified Body is important to an efficient and hassle-free CE marking process. Our approach focuses on open communication from the very beginning. Your application will be supported by a dedicated team of medical device experts.
Benefits of partnering with BSI
Of the world’s top 25 global medical device manufacturers, 23 choose BSI as their Notified Body for CE marking certification against the EU directives.
Just some of the reasons why manufacturers are getting a better experience:
- Internal product experts and auditors
- Over 700 years of technical expertise
- Full EU medical devices scope, MDD, AIMD, IVDD capability
- Single technical point of contact
- Reliability and predictability
Transfer to BSI in 10 easy steps
BSI provides a simple process for transferring ISO 13485, CE marking, CMDCAS, or Class III Design Dossier Certificates. This straightforward and efficient approach is designed around the specific needs of your company:
1. Meet and Greet - Come and talk to us, we can discuss your requirements dependant on your circumstances and future plans.
2. Proposal and Plan - We will prepare a transfer proposal from the discussed information and present it for your review and acceptance.
3. Submission - Submit your signed application, transfer plan, NB number change schedule to BSI. You will be assigned a single point of contact at BSI.
4. ISO 13485 Transfer - An assessment visit for ISO 13485 is required under the accreditation process for ISO registrations (not a CE Marking requirement).
5. CE Marking Transfer - The transfer of CE Marking requires a desktop review and it is performed on the data submitted by the manufacturer including all QMS data.
6. Recommendation for CE Marking - When BSI is ready to recommend for CE Marking, the manufacturer will need to provide written confirmation to the previous NB regarding the BSI transfer.
7. CE Marking Certificate Draft - BSI will provide draft CE Marking certificates to the manufacturer. These certificates must be signed by the manufacturer and returned to BSI.
8. Transition - BSI will write to the prior NB requesting confirmation that all certificates and the manufacturer are in "good-standing".
9. Panel Review
BSI CE Marking recommendation is submitted to the internal BSI Panel after BSI receives confirmation from the previous NB. And if accepted, the CE Marking Certificates are issued.
10. NB Number
The schedule for changing the NB number shall be initiated for new production as soon as our CE Certificates are issued. Completed devices already on the market can continue with the prior NB number.