BSI UK Becomes Second NB Designated Under IVDR

Regulatory NewsRegulatory News | 28 October 2019 |  By 

The European Commission on Monday updated its NANDO database to include BSI Assurance UK Ltd as the second notified body (NB) designated under the In Vitro Diagnostic Regulation (IVDR).

BSI said it is the first NB to achieve full scope designation, which covers all devices for IVDR. "This includes several new categories of devices with specific characteristics that were not covered by the In Vitro Diagnostics Directive [IVDD] such as cancer tests, genetic tests, physiological markers, and companion diagnostics," the company said in a statement.

BSI now joins Germany-based Dekra as the only NB designated under both IVDR and the Medical Devices Regulation (MDR). The other three NBs to be designated under MDR are: Italy-based IMQ Istituto, Germany-based TÜV SÜD and Germany-based TÜV Rheinland.

But NB capacity issues remain a lingering concern. According to MedTech Europe, 11 NBs under IVDR (compared to 40 under MDR) have sent completed applications to the EC’s DG Sante, and only six have had on-site inspections. But the commission is still forecasting about 20 NB designations for both IVDR and MDR by the end of 2019.

According to Team NB, 21 NBs are currently designated under the IVDD, but four of those designated under IVDD will not apply under IVDR, and three non-IVDD designated NBs have applied under IVDR.

Examples of NBs that have declined to seek designation under MDR and IVDR include London-based Lloyd's Register Quality Assurance (LRQA), which withdrew its NB services in June under the EU’s current directives and said it will not apply to be an NB under MDR or IVDR. Swiss NB QS Zürich AG also decided to not pursue designation under MDR.

European Commission’s NANDO Database


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