From September 1st, 2019 UL UK will restrict its designation as a Notified Body Under Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD). They will be limiting their scope under the IVDD to a single NBOG code, IVD 0308 (Risk of trisomy 21 (incl. software)). This implies from that date (September 1st), UL will only hold designation to IVD 0308 under the IVDD.

UL customers will be transferring their UL CE certificates across to the Polish Notified body, Polskie Centrum Badan I Certyfikacji S.A. (PCBC, NB 1434), with whom they have set up a partnership.

UL UK has reportedly not applied for designation under the MDR or IVDR.

What does this mean to you?

If you were working with UL as your notified body, and have as of yet not taken any action, you will need to appoint a new notified body for your products as soon as possible to ensure that you can continue placing your devices on the European market.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.


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